Determination — Pharmaceutical benefits
(PB 114 of 2008)
as amended
made under sections 85, 85A and 88 of the
National Health Act 1953
This compilation was prepared on 1 March 2010
taking into account amendments up to PB 5 of 2010
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Determinations — pharmaceutical benefits (PB 114 of 2008)
Commencement [see Note 1]
1. This instrument commences on 1 December 2008.
Repeal
2. Instrument number PB 75 of 2008 is repealed.
Definitions
3. In this instrument:
“Act” means the National Health Act 1953;
“base-priced drug” means —
(a) in relation to ranitidine (tablet, effervescent, 150 mg (as hydrochloride) or syrup 150 mg (as hydrochloride) per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine (tablet 150 mg (as hydrochloride) or tablet 300 mg (as hydrochloride)); or
(b) in relation to lercanidipine or nifedipine (tablet 20 mg (controlled release)): amlodipine, felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release)); or
(c) in relation to eprosartan (tablet 400 mg (as mesylate)): candesartan, eprosartan (tablet 600 mg (as mesylate)), irbesartan, olmesartan, telmisartan or valsartan;
“CFC” means chlorofluorocarbon;
“CFU” means colony forming unit;
“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;
“g” means gram;
“GP Management Plan” means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient's health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need;
“I.M.” means intramuscular;
“I.U.” means international unit;
“I.V.” means intravenous;
“kg” means kilogram;
“L” means litre;
“m” means metre;
“Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
“mg” means milligram;
“mL” means millilitre;
“mm” means millimetre;
“mmol” means millimole;
“palliative care patient”, in relation to a purpose specified in Part 2 of Schedule 2, means a patient with an active, progressive, far-advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;
“PBS” means Pharmaceutical Benefits Scheme;
“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;
“Team Care Arrangements” means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient.
Form
4. For the purposes of subsection 85(3) of the Act, where the strength, type of unit, size of unit or other particulars of form are mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 in relation to a listed drug, these particulars are the form or forms of that listed drug.
4A. For the purposes of subsection 85(3) of the Act, a form mentioned in Schedule 4 is a form of a medicinal preparation composed of one or more drugs or medicinal preparations, including a medicinal preparation containing an additive.
Manner of administration
5. For the purposes of subsection 85(5) of the Act, the manner of administration mentioned under the column headed “Manner of administration” in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a form of a listed drug is the manner of administration for that form of the listed drug.
Brand
5A. For the purposes of subsection 85(6) of the Act, a brand mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a listed drug in a pharmaceutical item, in a form and with a manner of administration mentioned for the listed drug, is the brand of that pharmaceutical item.
Participating dental practitioners
5B. For the purposes of subsection 88(1A) of the Act, the pharmaceutical benefits mentioned in Schedule 3 are the pharmaceutical benefits for the supply of which a participating dental practitioner is authorised to write a prescription.
Prescription
6. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit are the maximum quantities and number of repeats that a medical practitioner may prescribe or direct on one occasion for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
7. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 3 for a pharmaceutical benefit or pharmaceutical item are the maximum quantities and number of repeats that a participating dental practitioner may prescribe or direct on one occasion but only for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
8. For the purposes of subsection 85A(2) of the Act, the manner of administration, if any, mentioned for a pharmaceutical benefit in
(a) Schedule 1 or, if not mentioned in Schedule1, in Schedule 2, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or
(b) Schedule 3, is the only manner in which a participating dental practitioner may, in a prescription, direct the pharmaceutical benefit to be administered.
9. For the purposes of subsection 85A(2) of the Act, the maximum quantity or number of units of a pharmaceutical item or pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:
(a) where a pharmaceutical item or pharmaceutical benefit is mentioned —
(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(ii) in Part 2 of Schedule 1 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iv) in Part 2 of Schedule 2 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(v) in Part 1 of Schedule 3 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(vi) in Part 2 Schedule 3 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(b) in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in Schedule 4 for the form of the pharmaceutical benefit.
10. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit may, in one prescription, be directed by a medical practitioner to be repeated is:
(a) where the pharmaceutical benefit is mentioned —
(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(ii) in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iv) in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(b) in any other case — the number, if any, specified in the column headed “Maximum number of repeats” in Schedule 4 for the form of the pharmaceutical benefit.
11. Subject to paragraph 14, the following purposes are specified in relation to each pharmaceutical benefit mentioned in Part 2 of Schedule 1 or 2:
(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”
(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose;
(d) where it is specified in the column headed “Purposes” that compliance with authority procedures set out in subparagraph 11(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
(i) by delivering or posting to the Medicare Australia CEO the prescription prepared and signed by the medical practitioner:
(A) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or
(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(D) by a method approved in writing by the Secretary; or
(ii) by submitting the prescription by giving the Medicare Australia CEO by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or
(iii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or
(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).
11A. For the purposes of subparagraph 11(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.
12. Subject to paragraph 12B, the authorisation of a prescription submitted under subparagraph 11(d) may be made:
(a) if the prescription was submitted in accordance with subsubparagraph 11(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii) in any other case:
(A) by returning it to the medical practitioner; or
(B) by sending it to the person in respect of whom it was prepared; or
(b) if the prescription was submitted in accordance with subsubparagraph 11(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or
(c) if the prescription was submitted in accordance with subsubparagraph 11(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.
12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b) or (c):
(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and
(b) the medical practitioner must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
12B. Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
12BA. If a medical practitioner has written on a prescription, that has been prepared and signed in accordance with subsubparagraph 11(d)(i), the streamlined authority code mentioned in Part 2 of Schedule 1 for a pharmaceutical benefit and purpose:
(a) subparagraph 11(d) is taken to have been complied with; and
(b) the Medicare Australia CEO is taken to have authorised the prescription.
12BB. Paragraph 12BA applies to a prescription only if there is a streamlined authority code for the pharmaceutical benefit and purpose in Part 2 of Schedule 1.
12C. Where a prescription is authorised, or deemed to be authorised, in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated, the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.
13. The following purposes are specified in relation to a pharmaceutical benefit mentioned in Part 2 of Schedule 3:
(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes” —
(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose.
14. Where the purposes “For use in accordance with paragraph 14” are specified in the column headed “Purposes” in Part 2 of Schedule 1, the purposes specified for the purpose of subparagraph 11(c) are:
(a) that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient identified as being in one of the following very high risk categories:
(i) coronary heart disease which has become symptomatic;
(ii) cerebrovascular disease which has become symptomatic;
(iii) peripheral vascular disease which has become symptomatic;
(iv) diabetes mellitus with microalbuminuria (defined as urinary albumin excretion rate of greater than 20 micrograms per minute, or urinary albumin to creatinine ratio of greater than 2.5 for males or greater than 3.5 for females);
(v) diabetes mellitus in Aboriginal or Torres Strait Islander patients;
(vi) diabetes mellitus in patients aged 60 years or more;
(vii) family history of coronary heart disease which has become symptomatic before the age of 55 years in two or more first degree relatives;
(viii) family history of coronary heart disease which has become symptomatic before the age of 45 years in one or more first degree relatives; or
(b) if subparagraph 14(a) does not apply — that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient who, after at least 6 weeks of dietary therapy, qualifies for the supply of the benefit in accordance with the following table:
Category of patient | Fasting lipid level |
Patients with diabetes mellitus not otherwise included | total cholesterol greater than 5.5 mmol per L |
Aboriginal or Torres Strait Islander patients; Patients with hypertension | total cholesterol greater than 6.5 mmol per L; or total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L |
Patients with high density lipoprotein cholesterol less than 1 mmol per L | total cholesterol greater than 6.5 mmol per L |
Patients with familial hypercholesterolaemia identified by: (1) DNA mutation; or (2) tendon xanthomas in the patient or their first or second degree relative
Patients with: (1) family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or (2) family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives | If aged 18 years or less at treatment initiation: low density lipoprotein cholesterol greater than 4 mmol per L
If aged more than 18 years at treatment initiation: low density lipoprotein cholesterol greater than 5 mmol per L; or total cholesterol greater than 6.5 mmol per L; or total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L |
Patients not eligible under the above: (1) men over 34 but less than 76 years of age; or (2) post-menopausal women less than 76 years of age | total cholesterol greater than 7.5 mmol per L; or triglyceride greater than 4 mmol per L |
Patients not otherwise included | total cholesterol greater than 9 mmol per L; or triglyceride greater than 8 mmol per L |
SCHEDULE 1 – PART 1 | ||||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand | |
Abciximab | I.V. injection 10 mg in 5 mL vial | Injection | 3 | .. | ReoPro | |
Acamprosate | Tablet (enteric coated) containing acamprosate calcium 333 mg | Oral | 180 | 1 | Campral | |
Acarbose | Tablet 50 mg | Oral | 90 | 5 | Glucobay 50 | |
| Tablet 100 mg | Oral | 90 | 5 | Glucobay 100 | |
Acetazolamide | Tablet 250 mg | Oral | 100 | 3 | Diamox | |
Acetylcysteine | Inhalation solution 200 mg (as sodium) per mL, 5 mL | Inhalation | 30 | 3 | Mucomyst | |
Aciclovir | Tablet 200 mg | Oral | 50 | .. | Acihexal | |
|
|
|
|
| Acyclo-V 200 | |
|
|
|
|
| GenRx Aciclovir | |
|
|
|
|
| Lovir | |
|
|
|
|
| Zovirax 200 mg | |
| Tablet 800 mg | Oral | 35 | .. | Aciclovir 800 | |
|
|
|
|
| Acihexal | |
|
|
|
|
| Acyclo-V 800 | |
|
|
|
|
| GenRx Aciclovir | |
|
|
|
|
| Lovir | |
|
|
|
|
| Zovirax 800 mg | |
| Eye ointment 30 mg per g, 4.5 g | Application to the eye | 1 | .. | Zovirax | |
Acitretin | Capsule 10 mg | Oral | 100 | 2 | Neotigason | |
| Capsule 25 mg | Oral | 100 | 2 | Neotigason | |
Adalimumab | Injection 40 mg in 0.8 mL pre-filled syringe, 6 | Injection | 1 | .. | Humira | |
| Injection 40 mg in 0.8 mL pre-filled pen, 6 | Injection | 1 | .. | Humira | |
| Injection 40 mg in 0.8 mL pre-filled syringe | Injection | 2 | 2 | Humira | |
| Injection 40 mg in 0.8 mL pre-filled pen | Injection | 2 | 2 | Humira | |
Adrenaline | Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000) | Injection | 5 | 1 | AstraZeneca Pty Ltd | |
| I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector | Injection | 1 | .. | EpiPen Jr. | |
| I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector | Injection | 1 | .. | EpiPen | |
SCHEDULE 1 – PART 1 — continued | ||||||||||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand | |||||||
Albendazole | Tablet 200 mg | Oral | 6 | .. | Zentel | |||||||
| Tablet 400 mg | Oral | 60 | 2 | Eskazole | |||||||
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Oral | 4 | 5 | Adronat | |||||||
|
|
|
|
| Alendrobell 70mg | |||||||
|
|
|
|
| Alendronate-GA | |||||||
|
|
|
|
| Alendronate Sandoz | |||||||
|
|
|
|
| Alendro Once Weekly | |||||||
|
|
|
|
| APO-Alendronate | |||||||
|
|
|
|
| Chem mart Alendronate 70mg | |||||||
|
|
|
|
| Fosamax Once Weekly | |||||||
|
|
|
|
| Ossmax 70mg | |||||||
|
|
|
|
| Terry White Chemists Alendronate 70mg | |||||||
| Tablet 40 mg (as alendronate sodium) | Oral | 30 | 5 | Fosamax 40 mg | |||||||
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Oral | 4 | 5 | Fosamax Plus | |||||||
| Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Oral | 4 | 5 | Dronalen Plus Fosamax Plus 70 mg/140 mcg | |||||||
Alginic acid with calcium carbonate and sodium bicarbonate | Oral liquid containing alginic acid as sodium alginate 1 g, calcium carbonate 320 mg and sodium bicarbonate 534 mg in 20 mL, 500 mL | Oral | 2 | 5 | Gaviscon P | |||||||
Allopurinol | Tablet 100 mg | Oral | 200 | 2 | Allopurinol Sandoz | |||||||
|
|
|
|
| Allosig | |||||||
|
|
|
|
| Chem mart Allopurinol | |||||||
|
|
|
|
| GenRx Allopurinol | |||||||
|
|
|
|
| Progout 100 | |||||||
|
|
|
|
| Terry White Chemists Allopurinol | |||||||
|
|
|
|
| Zyloprim | |||||||
| Tablet 300 mg | Oral | 60 | 2 | Allopurinol Sandoz | |||||||
|
|
|
|
| Allosig | |||||||
|
|
|
|
| Chem mart Allopurinol | |||||||
|
|
|
|
| GenRx Allopurinol | |||||||
|
|
|
|
| Progout 300 | |||||||
|
|
|
|
| Terry White Chemists Allopurinol | |||||||
|
|
|
|
| Zyloprim | |||||||
Alprazolam | Tablet 250 micrograms | Oral | 50 | .. | Alprax 0.25 | |||||||
|
|
|
|
| Kalma 0.25 | |||||||
|
|
|
|
| Xanax | |||||||
|
|
|
|
| Zamhexal 0.25mg | |||||||
| Tablet 500 micrograms | Oral | 50 | .. | Alprax 0.5 | |||||||
|
|
|
|
| Alprazolam Sandoz | |||||||
|
|
|
|
| Kalma 0.5 | |||||||
|
|
|
|
| Xanax | |||||||
| Tablet 1 mg | Oral | 50 | 2 | Alprax 1 | |||||||
|
|
|
|
| Alprazolam-DP | |||||||
|
|
|
|
| Alprazolam-GA | |||||||
|
|
|
|
| Alprazolam Sandoz | |||||||
|
|
|
|
| Chem mart Alprazolam | |||||||
|
|
|
|
| GenRx Alprazolam | |||||||
|
|
|
|
| Kalma 1 | |||||||
|
|
|
|
| Terry White Chemists Alprazolam | |||||||
|
|
|
|
| Xanax | |||||||
| Tablet 2 mg | Oral | 50 | 2 | Alprax 2 | |||||||
|
|
|
|
| Alprazolam-GA | |||||||
|
|
|
|
| Alprazolam Sandoz | |||||||
|
|
|
|
| Chem mart Alprazolam | |||||||
|
|
|
|
| GenRx Alprazolam | |||||||
|
|
|
|
| Kalma 2 | |||||||
|
|
|
|
| Terry White Chemists Alprazolam | |||||||
|
|
|
|
| Xanax Tri-Score | |||||||
Aluminium Hydroxide with Magnesium Hydroxide | Oral suspension 200 mg-200 mg per 5 mL, 500 mL | Oral | 2 | 5 | Mylanta P | |||||||
Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide | Oral suspension 250 mg-120 mg-120 mg per 5 mL, 500 mL | Oral | 2 | 5 | Gastrogel | |||||||
Amantadine | Capsule containing amantadine hydrochloride 100 mg | Oral | 100 | 5 | Symmetrel 100 | |||||||
Amiloride | Tablet containing amiloride hydrochloride 5 mg | Oral | 100 | 1 | Kaluril | |||||||
Amino acid formula without methionine, threonine and valine and low in isoleucine | Oral powder 200 g (XMTVI Asadon) | Oral | 5 | 5 | XMTVI Asadon | |||||||
Amino acid formula without phenylalanine | Capsules 500 mg, 200 (Phlexy-10) | Oral | 16 | 5 | Phlexy-10 | |||||||
| Tablets 1 g, 75 (Phlexy-10) | Oral | 24 | 5 | Phlexy-10 | |||||||
| Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix) | Oral | 7 | 5 | Phlexy-10 Drink Mix | |||||||
Amino acid formula without phenylalanine, tyrosine and methionine | Oral powder 500 g (XPTM Tyrosidon) | Oral | 4 | 5 | XPTM Tyrosidon | |||||||
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | Oral powder 400 g (XP Analog LCP) | Oral | 8 | 5 | XP Analog LCP | |||||||
Amino acid formula with vitamins and minerals without lysine and low in tryptophan | Sachets containing oral powder 20 g, 30 (GA gel) | Oral | 4 | 5 | GA gel | |||||||
| Oral powder 400 g (XLYS, LOW TRY Analog) | Oral | 8 | 5 | XLYS, LOW TRY Analog | |||||||
| Oral powder 500 g (XLYS, LOW TRY Maxamaid) | Oral | 8 | 5 | XLYS, LOW TRY Maxamaid | |||||||
Amino acid formula with vitamins and minerals without methionine | Oral powder 400 g (XMET Analog) | Oral | 8 | 5 | XMET Analog | |||||||
| Sachets containing oral powder 20 g, 30 (HCU gel) | Oral | 4 | 5 | HCU gel | |||||||
| Sachets containing oral powder 25 g, 30 (HCU express) | Oral | 4 | 5 | HCU express | |||||||
| Oral powder 500 g (XMET Maxamaid) | Oral | 8 | 5 | XMET Maxamaid | |||||||
| Oral powder 500 g (XMET Maxamum) | Oral | 8 | 5 | XMET Maxamum | |||||||
| Oral liquid 130 mL, 30 (HCU Cooler) | Oral | 4 | 5 | HCU Cooler | |||||||
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | Oral powder 400 g (XMTVI Analog) | Oral | 8 | 5 | XMTVI Analog | |||||||
| Oral powder 500 g (XMTVI Maxamaid) | Oral | 8 | 5 | XMTVI Maxamaid | |||||||
| Oral powder 500 g (XMTVI Maxamum) | Oral | 8 | 5 | XMTVI Maxamum | |||||||
Amino acid formula with vitamins and minerals without phenylalanine | Sachets containing oral powder 18.2 g, 60 (add-ins) | Oral | 3 | 5 | add-ins | |||||||
| Sachets containing oral powder 20 g, 30 (PKU-gel) | Oral | 4 | 5 | PKU-gel | |||||||
| Sachets containing oral powder 25 g, 30 (PKU-Express) | Oral | 4 | 5 | PKU-Express | |||||||
| Sachets containing oral powder 27.8 g, 30 (Lophlex) | Oral | 3 | 5 | Lophlex | |||||||
| Sachets containing oral powder 29 g, 30 (PKU Anamix Junior) | Oral | 4 | 5 | PKU Anamix Junior | |||||||
| Sachets containing oral powder 50 g, 30 (XP Maxamum) | Oral | 3 | 5 | XP Maxamum | |||||||
| Oral powder 325 g (Phenex-2) | Oral | 10 | 5 | Phenex-2 | |||||||
| Oral powder 400 g (Phenex-2) | Oral | 8 | 5 | Phenex-2 | |||||||
| Oral powder 500 g (XP Maxamaid) | Oral | 8 | 5 | XP Maxamaid | |||||||
| Oral powder 500 g (XP Maxamum) | Oral | 8 | 5 | XP Maxamum | |||||||
| Oral liquid 250 mL (Easiphen) | Oral | 90 | 5 | Easiphen | |||||||
| Oral liquid 62.5 mL, 60 (PKU Lophlex LQ 10) | Oral | 2 | 5 | PKU Lophlex LQ 10 | |||||||
| Oral liquid 87 mL, 30 (PKU Cooler 10) | Oral | 4 | 5 | PKU Cooler 10 | |||||||
| Oral liquid 125 mL, 30 (PKU Lophlex LQ 20) | Oral | 3 | 5 | PKU Lophlex LQ 20 | |||||||
| Oral liquid 125 mL, 36 (PKU Anamix Junior LQ) | Oral | 4 | 5 | PKU Anamix Junior LQ | |||||||
| Oral liquid 130 mL, 30 (PKU Cooler 15) | Oral | 4 | 5 | PKU Cooler 15 | |||||||
| Oral liquid 174 mL, 30 (PKU Cooler 20) | Oral | 4 | 5 | PKU Cooler 20 | |||||||
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Sachets containing oral powder 20 g, 30 (TYR gel) | Oral | 4 | 5 | TYR gel | |||||||
| Sachets containing oral powder 25 g, 30 (TYR Express) | Oral | 4 | 5 | TYR Express | |||||||
| Sachets containing oral powder 29 g, 30 (TYR Anamix Junior) | Oral | 4 | 5 | TYR Anamix Junior | |||||||
| Oral powder 400 g (XPhen, Tyr Analog) | Oral | 8 | 5 | XPhen, Tyr Analog | |||||||
| Oral powder 500 g (XPhen, Tyr Maxamaid) | Oral | 8 | 5 | XPhen, Tyr Maxamaid | |||||||
| Oral powder 500 g (XPhen, Tyr Maxamum) | Oral | 8 | 5 | XPhen, Tyr Maxamum | |||||||
| Oral liquid 130 mL, 30 (TYR Cooler) | Oral | 4 | 5 | TYR Cooler | |||||||
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Sachets containing oral powder 20 g, 30 (MSUD-gel) | Oral | 4 | 5 | MSUD-gel | |||||||
| Sachets containing oral powder 25 g, 30 (MSUD Express) | Oral | 4 | 5 | MSUD Express | |||||||
| Sachets containing oral powder 29 g, 30 (Mapleflex) | Oral | 4 | 5 | Mapleflex | |||||||
| Oral powder 400 g (MSUD Analog) | Oral | 8 | 5 | MSUD Analog | |||||||
| Oral powder 500 g (MSUD AID III) | Oral | 4 | 5 | MSUD AID III | |||||||
| Oral powder 500 g (MSUD Maxamaid) | Oral | 8 | 5 | MSUD Maxamaid | |||||||
| Oral powder 500 g (MSUD Maxamum) | Oral | 8 | 5 | MSUD Maxamum | |||||||
| Oral liquid 130 mL, 30 (MSUD Cooler) | Oral | 4 | 5 | MSUD Cooler | |||||||
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid | Oral liquid 125 mL, 36 (MSUD Anamix Junior LQ) | Oral | 4 | 5 | MSUD Anamix Junior LQ | |||||||
Amino acids — synthetic, formula | Oral powder 400 g (EleCare) | Oral | 8 | 5 | EleCare | |||||||
| Oral powder 400 g (Neocate) | Oral | 8 | 5 | Neocate | |||||||
| Oral powder 400 g (Neocate Advance) | Oral | 8 | 5 | Neocate Advance | |||||||
| Oral powder 400 g (Neocate Advance Tropical Flavour) | Oral | 8 | 5 | Neocate Advance Tropical Flavour | |||||||
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) | Oral | 8 | 5 | Neocate LCP | |||||||
Amiodarone | Tablet containing amiodarone hydrochloride 100 mg | Oral | 30 | 5 | Aratac 100 | |||||||
|
|
|
|
| Cardinorm | |||||||
|
|
|
|
| Cordarone X 100 | |||||||
|
|
|
|
| Rithmik 100 | |||||||
| Tablet containing amiodarone hydrochloride 200 mg | Oral | 30 | 5 | Aratac 200 | |||||||
|
|
|
|
| Cardinorm | |||||||
|
|
|
|
| Chem mart Amiodarone | |||||||
|
|
|
|
| Cordarone X 200 | |||||||
|
|
|
|
| GenRx Amiodarone | |||||||
|
|
|
|
| Rithmik 200 | |||||||
|
|
|
|
| Terry White Chemists Amiodarone | |||||||
Amisulpride | Tablet 100 mg | Oral | 30 | 5 | Amisulpride 100 Winthrop Amisulpride Sandoz Solian 100 | |||||||
| Tablet 200 mg | Oral | 60 | 5 | Amisulpride 200 Winthrop Amisulpride Sandoz Solian 200 | |||||||
| Tablet 400 mg | Oral | 60 | 5 | Amipride 400 | |||||||
|
|
|
|
| Amisulpride 400 Winthrop | |||||||
|
|
|
|
| Amisulpride Sandoz | |||||||
|
|
|
|
| Solian 400 | |||||||
|
|
|
|
| Sulprix | |||||||
| Oral solution 100 mg per mL, 60 mL | Oral | 2 | 5 | Solian Solution | |||||||
Amitriptyline | Tablet containing amitriptyline hydrochloride 10 mg | Oral | 50 | 2 | Endep 10 | |||||||
| Tablet containing amitriptyline hydrochloride 25 mg | Oral | 50 | 2 | Endep 25 | |||||||
| Tablet containing amitriptyline hydrochloride 50 mg | Oral | 50 | 2 | Endep 50 | |||||||
Amlodipine | Tablet 5 mg (as besylate) | Oral | 30 | 5 | Amlodipine-GA | |||||||
|
|
|
|
| Amlodipine generichealth | |||||||
|
|
|
|
| Amlodipine Sandoz | |||||||
|
|
|
|
| APO-Amlodipine | |||||||
|
|
|
|
| Chem mart Amlodipine | |||||||
|
|
|
|
| Norvasc | |||||||
|
|
|
|
| Ozlodip | |||||||
|
|
|
|
| Perivasc | |||||||
|
|
|
|
| Pharmacor Amlodipine 5 | |||||||
|
|
|
|
| Terry White Chemists Amlodipine | |||||||
| Tablet 5 mg (as maleate) | Oral | 30 | 5 | Amlo 5 | |||||||
| Tablet 10 mg (as besylate) | Oral | 30 | 5 | Amlodipine-GA | |||||||
|
|
|
|
| Amlodipine generichealth | |||||||
|
|
|
|
| Amlodipine Sandoz | |||||||
|
|
|
|
| APO-Amlodipine | |||||||
|
|
|
|
| Chem mart Amlodipine | |||||||
|
|
|
|
| Norvasc | |||||||
|
|
|
|
| Ozlodip | |||||||
|
|
|
|
| Perivasc | |||||||
|
|
|
|
| Pharmacor Amlodipine 10 | |||||||
|
|
|
|
| Terry White Chemists Amlodipine | |||||||
| Tablet 10 mg (as maleate) | Oral | 30 | 5 | Amlo 10 | |||||||
Amlodipine with Atorvastatin | Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/10 | |||||||
| Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/20 | |||||||
| Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/40 | |||||||
| Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/80 | |||||||
| Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/10 | |||||||
| Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/20 | |||||||
| Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/40 | |||||||
| Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/80 | |||||||
Amlodipine with valsartan | Tablet 5 mg (as besylate)-80 mg | Oral | 28 | 5 | Exforge 5/80 | |||||||
| Tablet 5 mg (as besylate)-160 mg | Oral | 28 | 5 | Exforge 5/160 | |||||||
| Tablet 10 mg (as besylate)-160 mg | Oral | 28 | 5 | Exforge 10/160 | |||||||
Amoxycillin | Tablet 1 g (as trihydrate) | Oral | 14 | 1 | Amoxycillin Sandoz Maxamox | |||||||
| Capsule 250 mg (as trihydrate) | Oral | 20 | 1 | Alphamox 250 | |||||||
|
|
|
|
| Amoxil | |||||||
|
|
|
|
| Amoxycillin-DP | |||||||
|
|
|
|
| Amoxycillin-GA | |||||||
|
|
|
|
| Amoxycillin Ranbaxy Amoxycillin Sandoz | |||||||
|
|
|
|
| APO-Amoxycillin | |||||||
|
|
|
|
| Chem mart Amoxycillin | |||||||
|
|
|
|
| Cilamox | |||||||
|
|
|
|
| GenRx Amoxycillin | |||||||
|
|
|
|
| Terry White Chemists Amoxycillin | |||||||
| Capsule 500 mg (as trihydrate) | Oral | 20 | 1 | Alphamox 500 | |||||||
|
|
|
|
| Amoxil | |||||||
|
|
|
|
| Amoxycillin-DP | |||||||
|
|
|
|
| Amoxycillin Ranbaxy | |||||||
|
|
|
|
| Amoxycillin Sandoz | |||||||
|
|
|
|
| APO-Amoxycillin | |||||||
|
|
|
|
| Chem mart Amoxycillin | |||||||
|
|
|
|
| Cilamox | |||||||
|
|
|
|
| GenRx Amoxycillin | |||||||
|
|
|
|
| Moxacin | |||||||
|
|
|
|
| Terry White Chemists Amoxycillin | |||||||
| Sachet containing oral powder 3 g (as trihydrate) | Oral | 1 | .. | Amoxil | |||||||
| Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL | Oral | 1 | 1 | Amoxil | |||||||
| Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Alphamox 125 | |||||||
|
|
|
|
| Amoxil | |||||||
|
|
|
|
| Amoxycillin Sandoz | |||||||
|
|
|
|
| Bgramin | |||||||
|
|
|
|
| Chem mart Amoxycillin | |||||||
|
|
|
|
| GenRx Amoxycillin | |||||||
|
|
|
|
| Ranmoxy | |||||||
|
|
|
|
| Terry White Chemists Amoxycillin | |||||||
| Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Alphamox 250 | |||||||
|
|
|
|
| Amoxil Forte | |||||||
|
|
|
|
| Amoxycillin Sandoz | |||||||
|
|
|
|
| Bgramin | |||||||
|
|
|
|
| Chem mart Amoxycillin | |||||||
|
|
|
|
| Cilamox | |||||||
|
|
|
|
| GenRx Amoxycillin | |||||||
|
|
|
|
| Ranmoxy | |||||||
|
|
|
|
| Terry White Chemists Amoxycillin | |||||||
| Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Maxamox | |||||||
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | 1 | APO-Amoxycillin/Clavulanic Acid 500/125 | |||||||
|
|
|
|
| Augmentin Duo | |||||||
|
|
|
|
| Clamoxyl Duo | |||||||
|
|
|
|
| Curam Duo 500/125 | |||||||
|
|
|
|
| GA-Amclav 500/125 | |||||||
|
|
|
|
| Moxiclav Duo 500/125 | |||||||
| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | 1 | Augmentin Duo forte | |||||||
|
|
|
|
| Chem mart Amoxycillin and Clavulanic Acid | |||||||
|
|
|
|
| Clamoxyl Duo forte | |||||||
|
|
|
|
| Clavycillin 875/125 | |||||||
|
|
|
|
| Curam Duo Forte 875/125 | |||||||
|
|
|
|
| GA-Amclav Forte 875/125 | |||||||
|
|
|
|
| GenRx Amoxycillin and Clavulanic Acid | |||||||
|
|
|
|
| Moxiclav Duo Forte 875/125 | |||||||
|
|
|
|
| Terry White Chemists Amoxycillin and Clavulanic Acid | |||||||
| Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Oral | 1 | 1 | Augmentin | |||||||
|
|
|
|
| Clamoxyl | |||||||
|
|
|
|
| Curam | |||||||
| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | 1 | 1 | Augmentin Duo 400 | |||||||
|
|
|
|
| Clamoxyl Duo 400 | |||||||
|
|
|
|
| Curam Duo | |||||||
Amphotericin | Lozenge 10 mg | Oral | 20 | 1 | Fungilin | |||||||
| Powder for injection 50 mg | Injection | 1 | .. | Fungizone | |||||||
Ampicillin | Powder for injection 500 mg (as sodium) | Injection | 5 | 1 | Austrapen Ibimicyn | |||||||
| Powder for injection 1 g (as sodium) | Injection | 5 | 1 | Aspen Ampicyn Austrapen Ibimicyn | |||||||
Amylopectin, modified long chain | Sachets containing oral powder 60 g, 30 (Glycosade) | Oral | 4 | 5 | Glycosade | |||||||
Anakinra | Injection 100 mg in 0.67 mL single use pre-filled syringe | Injection | 28 | 3 | Kineret | |||||||
Anastrozole | Tablet 1 mg | Oral | 30 | 5 | Arimidex | |||||||
Apraclonidine | Eye drops 5 mg (as hydrochloride) per mL, 10 mL | Application to the eye | 1 | 2 | Iopidine 0.5% | |||||||
Aprepitant | Pack containing 1 capsule 125 mg and 2 capsules 80 mg | Oral | 1 | .. | Emend | |||||||
Arginine with carbohydrate | Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine Amino Acid Supplement) | Oral | 4 | 5 | Arginine Amino Acid Supplement | |||||||
Aripiprazole | Tablet 10 mg | Oral | 30 | 5 | Abilify | |||||||
| Tablet 15 mg | Oral | 30 | 5 | Abilify | |||||||
| Tablet 20 mg | Oral | 30 | 5 | Abilify | |||||||
| Tablet 30 mg | Oral | 30 | 5 | Abilify | |||||||
Arsenic | Injection concentrate containing arsenic trioxide 10 mg in | Injection | 60 | 2 | Phenasen | |||||||
Artemether with lumefantrine | Tablet 20 mg-120 mg | Oral | 24 | .. | Riamet | |||||||
Aspirin | Tablet 100 mg | Oral | 112 | 1 | Astrix DBL Aspirin 100 mg | |||||||
| Tablet, dispersible, 300 mg | Oral | 96 | 1 | Solprin | |||||||
Atenolol | Tablet 50 mg | Oral | 30 | 5 | Atehexal | |||||||
|
|
|
|
| Atenolol-GA | |||||||
|
|
|
|
| Chem mart Atenolol | |||||||
|
|
|
|
| GenRx Atenolol | |||||||
|
|
|
|
| Noten | |||||||
|
|
|
|
| Tenormin | |||||||
|
|
|
|
| Tensig | |||||||
|
|
|
|
| Terry White Chemists Atenolol | |||||||
Atomoxetine | Capsule 10 mg (as hydrochloride) | Oral | 56 | 5 | Strattera | |||||||
| Capsule 18 mg (as hydrochloride) | Oral | 56 | 5 | Strattera | |||||||
| Capsule 25 mg (as hydrochloride) | Oral | 56 | 5 | Strattera | |||||||
| Capsule 40 mg (as hydrochloride) | Oral | 56 | 5 | Strattera | |||||||
| Capsule 60 mg (as hydrochloride) | Oral | 56 | 5 | Strattera | |||||||
| Capsule 80 mg (as hydrochloride) | Oral | 28 | 5 | Strattera | |||||||
| Capsule 100 mg (as hydrochloride) | Oral | 28 | 5 | Strattera | |||||||
Atorvastatin | Tablet 10 mg (as calcium) | Oral | 30 | 5 | Lipitor | |||||||
| Tablet 20 mg (as calcium) | Oral | 30 | 5 | Lipitor | |||||||
| Tablet 40 mg (as calcium) | Oral | 30 | 5 | Lipitor | |||||||
| Tablet 80 mg (as calcium) | Oral | 30 | 5 | Lipitor | |||||||
Atovaquone | Oral suspension 750 mg per 5 mL, 210 mL | Oral | 1 | .. | Wellvone | |||||||
Atovaquone with proguanil | Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg | Oral | 12 | . . | Malarone | |||||||
Atropine | Injection containing atropine sulfate 600 micrograms in 1 mL | Injection | 10 | 1 | AstraZeneca Pty Ltd | |||||||
| Eye drops containing atropine sulfate 10 mg per mL, 15 mL | Application to the eye | 1 | 2 | Atropt | |||||||
Auranofin | Tablet 3 mg | Oral | 60 | 5 | Ridaura | |||||||
Aurothiomalate | Injection containing sodium aurothiomalate 10 mg | Injection | 10 | .. | Myocrisin | |||||||
| Injection containing sodium aurothiomalate 20 mg | Injection | 10 | 1 | Myocrisin | |||||||
| Injection containing sodium aurothiomalate 50 mg | Injection | 10 | 1 | Myocrisin | |||||||
Azathioprine | Tablet 25 mg | Oral | 100 | 2 | Azahexal Imuran | |||||||
| Tablet 50 mg | Oral | 100 | 2 | Azahexal | |||||||
|
|
|
|
| Azamun | |||||||
|
|
|
|
| Azapin | |||||||
|
|
|
|
| GenRx Azathioprine | |||||||
|
|
|
|
| Imuran | |||||||
|
|
|
|
| Thioprine | |||||||
Azithromycin | Tablet 500 mg (as dihydrate) | Oral | 2 | .. | Azithromycin Sandoz | |||||||
|
|
|
|
| Zithromax | |||||||
| Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL | Oral | 1 | .. | Zithromax | |||||||
Baclofen | Tablet 10 mg | Oral | 100 | 5 | Chem mart Baclofen | |||||||
|
|
|
|
| Clofen 10 | |||||||
|
|
|
|
| GenRx Baclofen | |||||||
|
|
|
|
| Lioresal 10 | |||||||
|
|
|
|
| Stelax 10 | |||||||
|
|
|
|
| Terry White Chemists Baclofen | |||||||
| Tablet 25 mg | Oral | 100 | 5 | Chem mart Baclofen | |||||||
|
|
|
|
| Clofen 25 | |||||||
|
|
|
|
| GenRx Baclofen | |||||||
|
|
|
|
| Lioresal 25 | |||||||
|
|
|
|
| Stelax 25 | |||||||
|
|
|
|
| Terry White Chemists Baclofen | |||||||
Balsalazide | Capsule containing balsalazide sodium 750 mg | Oral | 180 | 5 | Colazide | |||||||
“BCG Immunotherapeutic” (Bacillus Calmette-Guérin/ Connaught strain) | Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 108 CFU and 1 vial diluent 3 mL | Intravesical | 3 | 1 | ImmuCyst | |||||||
“BCG-Tice” (Bacillus Calmette-Guérin/ Tice strain) | Vial containing powder for intravesical administration approximately 5 x 108 CFU | Intravesical | 3 | 1 | OncoTICE | |||||||
Beclomethasone | Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Qvar 50 | |||||||
| Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Qvar 100 | |||||||
| Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Qvar 50 Autohaler | |||||||
| Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Qvar 100 Autohaler | |||||||
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe | Injection | 10 | .. | Bicillin L-A | |||||||
Benzhexol | Tablet containing benzhexol hydrochloride 2 mg | Oral | 200 | 2 | Artane | |||||||
| Tablet containing benzhexol hydrochloride 5 mg | Oral | 200 | 1 | Artane | |||||||
Benztropine | Tablet containing benztropine mesylate 2 mg | Oral | 60 | 2 | Benztrop | |||||||
| Injection containing benztropine mesylate 2 mg in 2 mL | Injection | 5 | .. | Cogentin | |||||||
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | 1 | Difflam | |||||||
Benzylpenicillin | Powder for injection 600 mg (as sodium) | Injection | 10 | 1 | BenPen | |||||||
| Powder for injection 3 g (as sodium) | Injection | 10 | .. | BenPen | |||||||
Betamethasone | Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL | Injection | 5 | .. | Celestone Chronodose | |||||||
| Cream 500 micrograms (as dipropionate) per g, 15 g | Application | 1 | 1 | Diprosone Eleuphrat | |||||||
| Cream 200 micrograms (as valerate) per g, 100 g | Application | 2 | .. | Antroquoril | |||||||
|
|
|
|
| Betnovate 1/5 | |||||||
|
|
|
|
| Celestone-M | |||||||
|
|
|
|
| Cortival 1/5 | |||||||
| Ointment 500 micrograms (as dipropionate) per g, 15 g | Application | 1 | 1 | Diprosone Eleuphrat | |||||||
| Cream 500 micrograms (as valerate) per g, 15 g | Application | 1 | 1 | Betnovate 1/2 Cortival 1/2 | |||||||
| Ointment 200 micrograms (as valerate) per g, 100 g | Application | 2 | .. | Antroquoril Celestone-M | |||||||
| Ointment 500 micrograms (as valerate) per g, 15 g | Application | 1 | 1 | Betnovate 1/2 Cortival 1/2 | |||||||
Betaxolol | Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Betoptic S | |||||||
| Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Betoptic BetoQuin | |||||||
Bethanechol | Tablet containing bethanechol hydrochloride 10 mg | Oral | 100 | 2 | Uro-Carb | |||||||
Bevacizumab | Solution for I.V. infusion 100 mg in 4 mL | Injection | 1 | . . | Avastin | |||||||
| Solution for I.V. infusion 400 mg in 16 mL | Injection | 1 | . . | Avastin | |||||||
Bicalutamide | Tablet 50 mg | Oral | 28 | 5 | APO-Bicalutamide | |||||||
|
|
|
|
| Bicalutamide-GA | |||||||
|
|
|
|
| Bicalutamide Ranbaxy | |||||||
|
|
|
|
| Calutex | |||||||
|
|
|
|
| Cosamide | |||||||
|
|
|
|
| Cosudex | |||||||
Bimatoprost | Eye drops 300 micrograms per mL, 3 mL | Application to the eye | 1 | 5 | Lumigan | |||||||
Bimatoprost with timolol | Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL | Application to the eye | 1 | 5 | Ganfort 0.3/5 | |||||||
Biperiden | Tablet containing biperiden hydrochloride 2 mg | Oral | 200 | 2 | Akineton | |||||||
Bisacodyl | Tablet 5 mg | Oral | 200 | 2 | Bisalax Lax-Tab | |||||||
| Suppositories 10 mg, 10 | Rectal | 3 | 5 | Dulcolax Petrus Bisacodyl Suppositories | |||||||
| Suppositories 10 mg, 12 | Rectal | 3 | 4 | Petrus Bisacodyl Suppositories | |||||||
| Enemas 10 mg in 5 mL, 25 | Rectal | 1 | 2 | Bisalax | |||||||
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Oral | 28 | 5 | Bicor | |||||||
|
|
|
|
| Bisoprolol Sandoz | |||||||
|
|
|
|
| Bispro 2.5 | |||||||
| Tablet containing bisoprolol fumarate 5 mg | Oral | 28 | 5 | Bicor | |||||||
|
|
|
|
| Bisoprolol Sandoz | |||||||
|
|
|
|
| Bispro 5 | |||||||
| Tablet containing bisoprolol fumarate 10 mg | Oral | 28 | 5 | Bicor | |||||||
|
|
|
|
| Bisoprolol Sandoz | |||||||
|
|
|
|
| Bispro 10 | |||||||
Bivalirudin | Powder for I.V. injection 250 mg (as trifluoroacetate) | Injection | 1 | .. | Angiomax | |||||||
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Blenamax Blenoxane Hospira Pty Limited | |||||||
Bortezomib | Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) | Injection | 4 | 2 | Velcade | |||||||
Brimonidine | Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL | Application to the eye | 1 | 5 | Alphagan Enidin | |||||||
Brimonidine with Timolol | Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Combigan | |||||||
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Application to the eye | 1 | 5 | Azopt BrinzoQuin | |||||||
Bromocriptine | Tablet 2.5 mg (as mesylate) | Oral | 30 | .. | Kripton 2.5 Parlodel | |||||||
| Capsule 5 mg (as mesylate) | Oral | 60 | 5 | Kripton 5 Parlodel | |||||||
| Capsule 10 mg (as mesylate) | Oral | 100 | 5 | Kripton 10 Parlodel | |||||||
Budesonide | Nebuliser suspension 500 micrograms in 2 mL single dose units, 30 | Inhalation | 1 | 5 | Pulmicort Respules | |||||||
| Nebuliser suspension 1 mg in 2 mL single dose units, 30 | Inhalation | 1 | 5 | Pulmicort Respules | |||||||
| Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler | |||||||
| Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler | |||||||
| Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler | |||||||
Budesonide with Eformoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 100/6 | |||||||
| Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 200/6 | |||||||
| Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 400/12 | |||||||
Buprenorphine | Transdermal patch 5 mg | Transdermal | 2 | .. | Norspan | |||||||
| Transdermal patch 10 mg | Transdermal | 2 | .. | Norspan | |||||||
| Transdermal patch 20 mg | Transdermal | 2 | .. | Norspan | |||||||
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) | Oral | 30 | .. | Clorprax | |||||||
|
|
|
|
| Prexaton | |||||||
|
|
|
|
| Zyban | |||||||
Busulfan | Tablet 2 mg | Oral | 100 | .. | Myleran | |||||||
Cabergoline | Tablet 500 micrograms | Oral | 2 | .. | Dostinex | |||||||
| Tablet 1 mg | Oral | 30 | 5 | Bergoline 1 | |||||||
|
|
|
|
| Cabaser | |||||||
| Tablet 2 mg | Oral | 30 | 5 | Bergoline 2 | |||||||
|
|
|
|
| Cabaser | |||||||
Calcipotriol | Cream 50 micrograms (as monohydrate) per g, 30 g | Application | 1 | 1 | Daivonex | |||||||
| Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL | Application | 1 | 1 | Daivonex | |||||||
Calcipotriol with betamethasone | Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g | Application | 1 | 1 | Daivobet | |||||||
Calcitriol | Capsule 0.25 microgram | Oral | 100 | 3 | Calcitriol-DP | |||||||
|
|
|
|
| Calcitriol-GA | |||||||
|
|
|
|
| Citrihexal | |||||||
|
|
|
|
| GenRx Calcitriol | |||||||
|
|
|
|
| Kosteo | |||||||
|
|
|
|
| Rocaltrol | |||||||
|
|
|
|
| Sical | |||||||
Calcium | Tablet, chewable, 500 mg (as carbonate) | Oral | 240 | 1 | Cal-Sup | |||||||
| Tablet 600 mg (as carbonate) | Oral | 240 | 1 | Calci-Tab 600 | |||||||
Candesartan | Tablet containing candesartan cilexetil 4 mg | Oral | 30 | 5 | Atacand | |||||||
| Tablet containing candesartan cilexetil 8 mg | Oral | 30 | 5 | Atacand | |||||||
| Tablet containing candesartan cilexetil 16 mg | Oral | 30 | 5 | Atacand | |||||||
| Tablet containing candesartan cilexetil 32 mg | Oral | 30 | 5 | Atacand | |||||||
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Atacand Plus 16/12.5 | |||||||
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Atacand Plus 32/12.5 | |||||||
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg | Oral | 30 | 5 | Atacand Plus 32/25 | |||||||
Capecitabine | Tablet 150 mg | Oral | 60 | 2 | Xeloda | |||||||
| Tablet 500 mg | Oral | 120 | 2 | Xeloda | |||||||
Captopril | Tablet 12.5 mg | Oral | 90 | 5 | Captohexal | |||||||
|
|
|
|
| GenRx Captopril | |||||||
|
|
|
|
| Zedace | |||||||
| Tablet 25 mg | Oral | 90 | 5 | Capoten | |||||||
|
|
|
|
| Captopril Sandoz | |||||||
|
|
|
|
| Genepharm Pty Ltd | |||||||
|
|
|
|
| GenRx Captopril | |||||||
|
|
|
|
| Zedace | |||||||
| Tablet 50 mg | Oral | 90 | 5 | Capoten | |||||||
|
|
|
|
| Captohexal | |||||||
|
|
|
|
| Genepharm Pty Ltd | |||||||
|
|
|
|
| GenRx Captopril | |||||||
|
|
|
|
| Zedace | |||||||
| Oral solution 5 mg per mL, 95 mL | Oral | 1 | 5 | Capoten | |||||||
Carbamazepine | Tablet 100 mg | Oral | 200 | 2 | Carbamazepine Sandoz Tegretol 100 | |||||||
| Tablet 200 mg | Oral | 200 | 2 | Carbamazepine Sandoz Tegretol 200 Teril | |||||||
| Tablet 200 mg (controlled release) | Oral | 200 | 2 | Tegretol CR 200 | |||||||
| Tablet 400 mg (controlled release) | Oral | 200 | 2 | Tegretol CR 400 | |||||||
| Oral suspension 100 mg per 5 mL, 300 mL | Oral | 1 | 5 | Tegretol Liquid | |||||||
Carbimazole | Tablet 5 mg | Oral | 200 | 2 | Neo-Mercazole | |||||||
Carbohydrate, fat, vitamins, minerals and trace elements | Oral powder 400 g (Pro-Phree) | Oral | 8 | 5 | Pro-Phree | |||||||
| Oral powder 400 g (Energivit) | Oral | 8 | 5 | Energivit | |||||||
Carbomer | Eye gel 2 mg per g, 10 g | Application to the eye | 1 | 5 | GelTears PAA Viscotears | |||||||
| Eye gel 2 mg per g, single dose units 0.6 mL, 30 | Application to the eye | 3 | 5 | Viscotears | |||||||
Carbomer 974 | Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30 | Application to the eye | 3 | 5 | Poly Gel | |||||||
Carboplatin | Solution for I.V. injection 50 mg in 5 mL | Injection | 2 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
| Solution for I.V. injection 150 mg in 15 mL | Injection | 6 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
| Solution for I.V. injection 450 mg in 45 mL | Injection | 2 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
Carmellose | Eye drops containing carmellose sodium 5 mg per mL, 15 mL | Application to the eye | 1 | 5 | Refresh Tears Plus | |||||||
| Eye drops containing carmellose sodium 10 mg per mL, 15 mL | Application to the eye | 1 | 5 | Refresh Liquigel | |||||||
| Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 | Application to the eye | 4 | 5 | TheraTears | |||||||
| Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 | Application to the eye | 3 | 5 | Cellufresh | |||||||
| Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 | Application to the eye | 3 | 5 | Celluvisc | |||||||
| Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 | Application to the eye | 3 | 5 | TheraTears | |||||||
Carmellose with glycerin | Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL | Application to the eye | 1 | 3 | Optive | |||||||
Carmustine | Implants 7.7 mg, 8 | Implantation | 1 | .. | Gliadel | |||||||
Carvedilol | Tablet 3.125 mg | Oral | 30 | .. | Chem mart Carvedilol 3.125 mg | |||||||
|
|
|
|
| Dilasig 3.125 | |||||||
|
|
|
|
| Dilatrend 3.125 | |||||||
|
|
|
|
| GenRx Carvedilol | |||||||
|
|
|
|
| GN-Carvedilol | |||||||
|
|
|
|
| Kredex | |||||||
|
|
|
|
| Terry White Chemists Carvedilol 3.125 mg | |||||||
|
|
|
|
| Vedilol 3.125 | |||||||
| Tablet 6.25 mg | Oral | 60 | 5 | Carvedilol generichealth | |||||||
|
|
|
|
| Carvedilol Sandoz | |||||||
|
|
|
|
| Chem mart Carvedilol 6.25 mg | |||||||
|
|
|
|
| Dilasig 6.25 | |||||||
|
|
|
|
| Dilatrend 6.25 | |||||||
|
|
|
|
| GenRx Carvedilol | |||||||
|
|
|
|
| GN-Carvedilol | |||||||
|
|
|
|
| Kredex | |||||||
|
|
|
|
| Terry White Chemists Carvedilol 6.25 mg | |||||||
|
|
|
|
| Vedilol 6.25 | |||||||
| Tablet 12.5 mg | Oral | 60 | 5 | Carvedilol generichealth | |||||||
|
|
|
|
| Carvedilol Sandoz | |||||||
|
|
|
|
| Chem mart Carvedilol 12.5 mg | |||||||
|
|
|
|
| Dilasig 12.5 | |||||||
|
|
|
|
| Dilatrend 12.5 | |||||||
|
|
|
|
| GenRx Carvedilol | |||||||
|
|
|
|
| GN-Carvedilol | |||||||
|
|
|
|
| Kredex | |||||||
|
|
|
|
| Terry White Chemists Carvedilol 12.5 mg | |||||||
|
|
|
|
| Vedilol 12.5 | |||||||
| Tablet 25 mg | Oral | 60 | 5 | Carvedilol generichealth | |||||||
|
|
|
|
| Carvedilol Sandoz | |||||||
|
|
|
|
| Chem mart Carvedilol 25 mg | |||||||
|
|
|
|
| Dilasig 25 | |||||||
|
|
|
|
| Dilatrend 25 | |||||||
|
|
|
|
| GenRx Carvedilol | |||||||
|
|
|
|
| GN-Carvedilol | |||||||
|
|
|
|
| Kredex | |||||||
|
|
|
|
| Terry White Chemists Carvedilol 25 mg | |||||||
|
|
|
|
| Vedilol 25 | |||||||
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Oral | 10 | 1 | Ceclor CD | |||||||
|
|
|
|
| Cefaclor-GA | |||||||
|
|
|
|
| Chem mart Cefaclor CD | |||||||
|
|
|
|
| Douglas Cefaclor-CD | |||||||
|
|
|
|
| GenRx Cefaclor CD | |||||||
|
|
|
|
| Karlor CD | |||||||
|
|
|
|
| Keflor CD | |||||||
|
|
|
|
| Ozcef | |||||||
|
|
|
|
| Terry White Chemists Cefaclor CD | |||||||
| Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Aclor 125 | |||||||
|
|
|
|
| Ceclor | |||||||
|
|
|
|
| Cefaclor Sandoz | |||||||
|
|
|
|
| Chem mart Cefaclor | |||||||
|
|
|
|
| GenRx Cefaclor | |||||||
|
|
|
|
| Keflor | |||||||
|
|
|
|
| Ozcef | |||||||
|
|
|
|
| Terry White Chemists Cefaclor | |||||||
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Oral | 1 | 1 | Aclor 250 | |||||||
|
|
|
|
| Ceclor | |||||||
|
|
|
|
| Cefaclor Sandoz | |||||||
|
|
|
|
| Chem mart Cefaclor | |||||||
|
|
|
|
| GenRx Cefaclor | |||||||
|
|
|
|
| Keflor | |||||||
|
|
|
|
| Ozcef | |||||||
|
|
|
|
| Terry White Chemists Cefaclor | |||||||
Cefalotin | Powder for injection 1 g (as sodium) | Injection | 10 | 1 | Cefalotin Sandoz Hospira Pty Limited Keflin Neutral | |||||||
Cefepime | Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Maxipime | |||||||
| Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Maxipime | |||||||
Cefotaxime | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited | |||||||
| Powder for injection 2 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited | |||||||
Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | 1 | .. | Ceftriaxone ICP | |||||||
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Ceftriaxone ICP | |||||||
|
|
|
|
| Ceftriaxone Sandoz | |||||||
|
|
|
|
| DBL Ceftriaxone | |||||||
|
|
|
|
| Max Pharma Pty Ltd | |||||||
|
|
|
|
| Rocephin | |||||||
| Powder for injection 2 g (as sodium) | Injection | 5 | .. | Ceftriaxone ICP | |||||||
|
|
|
|
| Ceftriaxone Sandoz | |||||||
|
|
|
|
| DBL Ceftriaxone | |||||||
|
|
|
|
| Rocephin | |||||||
Cefuroxime | Tablet 250 mg (as axetil) | Oral | 14 | 1 | Zinnat | |||||||
Celecoxib | Capsule 100 mg | Oral | 60 | 3 | Celebrex | |||||||
| Capsule 200 mg | Oral | 30 | 3 | Celebrex | |||||||
Cephalexin | Capsule 250 mg (anhydrous) | Oral | 20 | 1 | Cephalexin generichealth | |||||||
|
|
|
|
| Cefalexin Sandoz | |||||||
|
|
|
|
| Cephabell | |||||||
|
|
|
|
| Cephatrust 250 | |||||||
|
|
|
|
| Chem mart Cephalexin | |||||||
|
|
|
|
| Cilex | |||||||
|
|
|
|
| GenRx Cephalexin | |||||||
|
|
|
|
| Ialex | |||||||
|
|
|
|
| Ibilex 250 | |||||||
|
|
|
|
| Keflex | |||||||
|
|
|
|
| Rancef | |||||||
|
|
|
|
| Terry White Chemists Cephalexin | |||||||
| Capsule 500 mg (anhydrous) | Oral | 20 | 1 | Cefalexin Sandoz | |||||||
|
|
|
|
| Cephabell | |||||||
|
|
|
|
| Cephalexin generichealth | |||||||
|
|
|
|
| Cephatrust 500 | |||||||
|
|
|
|
| Chem mart Cephalexin | |||||||
|
|
|
|
| Cilex | |||||||
|
|
|
|
| GenRx Cephalexin | |||||||
|
|
|
|
| Ialex | |||||||
|
|
|
|
| Ibilex 500 | |||||||
|
|
|
|
| Keflex | |||||||
|
|
|
|
| Rancef | |||||||
|
|
|
|
| Terry White Chemists Cephalexin | |||||||
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Oral | 1 | 1 | Cefalexin Sandoz | |||||||
|
|
|
|
| Chem mart Cephalexin | |||||||
|
|
|
|
| Cilex | |||||||
|
|
|
|
| GenRx Cephalexin | |||||||
|
|
|
|
| Ialex | |||||||
|
|
|
|
| Ibilex 125 | |||||||
|
|
|
|
| Keflex | |||||||
|
|
|
|
| Terry White Chemists Cephalexin | |||||||
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Oral | 1 | 1 | Cefalexin Sandoz | |||||||
|
|
|
|
| Chem mart Cephalexin | |||||||
|
|
|
|
| Cilex | |||||||
|
|
|
|
| GenRx Cephalexin | |||||||
|
|
|
|
| Ialex | |||||||
|
|
|
|
| Ibilex 250 | |||||||
|
|
|
|
| Keflex | |||||||
|
|
|
|
| Terry White Chemists Cephalexin | |||||||
Cephazolin | Powder for injection 500 mg (as sodium) | Injection | 10 | .. | Hospira Pty Limited | |||||||
| Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefazolin Sandoz Hospira Pty Limited Kefzol | |||||||
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | 1 | .. | Erbitux | |||||||
| Solution for I.V. infusion 100 mg in 50 mL | Injection | 1 | .. | Erbitux | |||||||
| Solution for I.V. infusion 500 mg in 100 mL | Injection | 1 | .. | Erbitux | |||||||
Chlorambucil | Tablet 2 mg | Oral | 100 | 2 | Leukeran | |||||||
Chloramphenicol | Ear drops (aqueous) 5 mg per mL, 5 mL | Application to the ear | 1 | 2 | Chloromycetin | |||||||
| Eye drops 5 mg per mL, 10 mL | Application to the eye | 1 | 2 | Chloromycetin Chlorsig | |||||||
| Eye ointment 10 mg per g, 4 g | Application to the eye | 1 | .. | Chloromycetin Chlorsig | |||||||
Chlorpromazine | Tablet containing chlorpromazine hydrochloride 10 mg | Oral | 100 | 5 | Largactil | |||||||
| Tablet containing chlorpromazine hydrochloride 25 mg | Oral | 100 | 5 | Largactil | |||||||
| Tablet containing chlorpromazine hydrochloride 100 mg | Oral | 100 | 5 | Largactil | |||||||
| Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL | Oral | 1 | 5 | Largactil | |||||||
| Injection containing chlorpromazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Largactil | |||||||
Chlorthalidone | Tablet 25 mg | Oral | 100 | 1 | Hygroton 25 | |||||||
Cholestyramine | Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50 | Oral | 2 | 5 | Questran Lite | |||||||
Chorionic Gonadotrophin | Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL | Injection | 1 | 5 | Pregnyl | |||||||
Ciclesonide | Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Alvesco 80 | |||||||
| Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Alvesco 160 | |||||||
Cimetidine | Tablet 200 mg | Oral | 120 | 5 | Magicul 200 | |||||||
| Tablet 400 mg | Oral | 60 | 5 | GenRx Cimetidine Magicul 400 Tagamet | |||||||
| Tablet 800 mg | Oral | 30 | 5 | GenRx Cimetidine Magicul 800 | |||||||
Cinacalcet | Tablet 30 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar | |||||||
| Tablet 60 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar | |||||||
| Tablet 90 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar | |||||||
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Oral | 14 | .. | C-Flox 500 | |||||||
|
|
|
|
| Cifran | |||||||
|
|
|
|
| Ciprofloxacin 500 | |||||||
|
|
|
|
| Ciprofloxacin-BW | |||||||
|
|
|
|
| Ciprofloxacin-GA | |||||||
|
|
|
|
| Ciprol 500 | |||||||
|
|
|
|
| Ciproxin 500 | |||||||
|
|
|
|
| Genepharm (Australia) Limited | |||||||
|
|
|
|
| GenRx Ciprofloxacin | |||||||
|
|
|
|
| Profloxin | |||||||
| Tablet 750 mg (as hydrochloride) | Oral | 14 | .. | C-Flox 750 | |||||||
|
|
|
|
| Cifran | |||||||
|
|
|
|
| Ciprofloxacin 750 | |||||||
|
|
|
|
| Ciprofloxacin-BW | |||||||
|
|
|
|
| Ciprol 750 | |||||||
|
|
|
|
| Ciproxin 750 | |||||||
|
|
|
|
| Genepharm (Australia) Limited | |||||||
|
|
|
|
| GenRx Ciprofloxacin | |||||||
|
|
|
|
| Profloxin | |||||||
| Tablet 250 mg (as hydrochloride) | Oral | 2 | .. | Ciproxin 250 | |||||||
| Ear drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the ear | 1 | 1 | Ciloxan | |||||||
| Eye drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 2 | .. | CiloQuin Ciloxan | |||||||
Cisplatin | I.V. injection 10 mg in 10 mL | Injection | 1 | .. | Pfizer Australia Pty Ltd | |||||||
| I.V. injection 50 mg in 50 mL | Injection | 1 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
| I.V. injection 100 mg in 100 mL | Injection | 1 | .. | Cisplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
Citalopram | Tablet 10 mg (as hydrobromide) | Oral | 28 | 5 | Celapram | |||||||
| Tablet 20 mg (as hydrobromide) | Oral | 28 | 5 | APO-Citalopram | |||||||
|
|
|
|
| Celapram | |||||||
|
|
|
|
| Celica | |||||||
|
|
|
|
| Chem mart Citalopram | |||||||
|
|
|
|
| Ciazil | |||||||
|
|
|
|
| Cipramil | |||||||
|
|
|
|
| Citalobell | |||||||
|
|
|
|
| Citalopram 20 | |||||||
|
|
|
|
| Citalopram generichealth | |||||||
|
|
|
|
| Citalopram Sandoz | |||||||
|
|
|
|
| GenRx Citalopram | |||||||
|
|
|
|
| Talam | |||||||
|
|
|
|
| Terry White Chemists Citalopram | |||||||
| Tablet 40 mg (as hydrobromide) | Oral | 28 | 5 | APO-Citalopram Celapram Citalopram Sandoz GenRx Citalopram | |||||||
Cladribine | Injection 10 mg in 5 mL | Injection | 7 | .. | Litak | |||||||
| Solution for I.V. infusion 10 mg in 10 mL single use vial | Injection | 7 | .. | Leustatin | |||||||
Clarithromycin | Tablet 250 mg | Oral | 14 | 1 | APO-Clarithromycin | |||||||
|
|
|
|
| Chem mart Clarithromycin | |||||||
|
|
|
|
| Clarac | |||||||
|
|
|
|
| Clarihexal | |||||||
|
|
|
|
| Clarithro 250 | |||||||
|
|
|
|
| GenRx Clarithromycin | |||||||
|
|
|
|
| Kalixocin | |||||||
|
|
|
|
| Klacid | |||||||
|
|
|
|
| Terry White Chemists Clarithromycin | |||||||
| Powder for oral liquid 250 mg per 5 mL, 50 mL | Oral | 1 | .. | Klacid | |||||||
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | 24 | .. | Cleocin Dalacin C | |||||||
Clodronic Acid | Capsule containing 400 mg sodium clodronate (as tetrahydrate) | Oral | 100 | 2 | Bonefos | |||||||
| Capsule containing 800 mg sodium clodronate (as tetrahydrate) | Oral | 60 | 2 | Bonefos 800 mg | |||||||
Clomiphene | Tablet containing clomiphene citrate 50 mg | Oral | 10 | 5 | Clomid | |||||||
|
|
|
|
| Serophene | |||||||
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Oral | 50 | 2 | Anafranil 25 | |||||||
|
|
|
|
| Chem mart Clomipramine | |||||||
|
|
|
|
| GenRx Clomipramine | |||||||
|
|
|
|
| Placil | |||||||
|
|
|
|
| Terry White Chemists Clomipramine | |||||||
Clonazepam | Tablet 500 micrograms | Oral | 200 | 2 | Paxam 0.5 Rivotril | |||||||
| Tablet 2 mg | Oral | 200 | 2 | Paxam 2 Rivotril | |||||||
| Oral liquid 2.5 mg per mL, 10 mL | Oral | 2 | .. | Rivotril | |||||||
| Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) | Injection | 5 | .. | Rivotril | |||||||
Clonidine | Tablet containing clonidine hydrochloride 100 micrograms | Oral | 100 | 5 | Catapres 100 | |||||||
| Tablet containing clonidine hydrochloride 150 micrograms | Oral | 100 | 5 | Catapres | |||||||
Clopidogrel | Tablet 75 mg (as hydrogen sulfate) | Oral | 28 | 5 | Iscover Plavix | |||||||
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulfate)-100 mg | Oral | 30 | 5 | CoPlavix DuoCover | |||||||
Clotrimazole | Cream 10 mg per g, 20 g | Application | 2 | 3 | Clonea | |||||||
| Lotion 10 mg per mL, 20 mL | Application | 2 | 3 | Canesten | |||||||
Coal Tar - Prepared | Gel 10 mg per g, 100 mL | Application | 1 | 2 | Exorex | |||||||
Codeine | Tablet containing codeine phosphate 30 mg | Oral | 20 | .. | Fawns and McAllan Proprietary Limited | |||||||
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Oral | 20 | .. | APO-Paracetamol/Codeine 500/30 | |||||||
|
|
|
|
| Codalgin Forte | |||||||
|
|
|
|
| Codapane Forte | |||||||
|
|
|
|
| Comfarol Forte | |||||||
|
|
|
|
| Dolaforte | |||||||
|
|
|
|
| Panadeine Forte | |||||||
|
|
|
|
| Prodeine Forte | |||||||
Colchicine | Tablet 500 micrograms | Oral | 100 | 2 | Colgout Lengout | |||||||
Colestipol | Oral powder, sachets containing colestipol hydrochloride 5 g, 120 | Oral | 1 | 5 | Colestid | |||||||
Copper Sulfate | Tablets, diagnostic compound, 36 | For external use | 2 | 3 | Clinitest | |||||||
Cortisone | Tablet containing cortisone acetate 5 mg | Oral | 50 | 4 | Cortate | |||||||
| Tablet containing cortisone acetate 25 mg | Oral | 60 | 4 | Cortate | |||||||
Cromoglycic Acid | Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic) | Inhalation by mouth | 100 | 5 | Intal Spincaps | |||||||
| Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses | Inhalation by mouth | 1 | 5 | Intal | |||||||
| Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Intal CFC-Free | |||||||
| Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Intal Forte CFC-Free | |||||||
| Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL | Application to the eye | 1 | 5 | Cromolux Opticrom | |||||||
Cyclophosphamide | Tablet 50 mg | Oral | 50 | 2 | Cycloblastin | |||||||
| Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 2 | .. | Endoxan | |||||||
| Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 1 | .. | Endoxan | |||||||
| Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 1 | .. | Endoxan | |||||||
Cyclosporin | Capsule 10 mg | Oral | 120 | 3 | Neoral 10 | |||||||
| Capsule 25 mg | Oral | 60 | 3 | Cicloral Neoral 25 | |||||||
| Capsule 50 mg | Oral | 60 | 3 | Cicloral Neoral 50 | |||||||
| Capsule 100 mg | Oral | 60 | 3 | Cicloral Neoral 100 | |||||||
| Oral liquid 100 mg per mL, 50 mL | Oral | 2 | 3 | Neoral | |||||||
Cyproheptadine | Tablet containing cyproheptadine hydrochloride 4 mg (anhydrous) | Oral | 100 | 2 | Periactin | |||||||
Cyproterone | Tablet containing cyproterone acetate 50 mg | Oral | 20 | 5 | Androcur | |||||||
|
|
|
|
| Cyprohexal | |||||||
|
|
|
|
| Cyprone | |||||||
|
|
|
|
| Cyprostat | |||||||
|
|
|
|
| GenRx Cyproterone Acetate | |||||||
|
|
|
|
| Procur | |||||||
| Tablet containing cyproterone acetate 100 mg | Oral | 50 | 5 | Androcur-100 | |||||||
|
|
|
|
| Cyprohexal | |||||||
|
|
|
|
| Cyprostat-100 | |||||||
|
|
|
|
| GenRx Cyproterone Acetate | |||||||
|
|
|
|
| Procur 100 | |||||||
Cystine with carbohydrate | Sachets of oral powder 4 g containing 500 mg cystine, 30 (Cystine Amino Acid Supplement) | Oral | 4 | 5 | Cystine Amino Acid Supplement | |||||||
Cytarabine | Injection 100 mg in 5 mL vial | Injection | 10 | 1 | Pfizer Australia Pty Ltd | |||||||
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe | Injection | 10 | 1 | Fragmin | |||||||
| Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe | Injection | 10 | 1 | Fragmin | |||||||
| Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe | Injection | 10 | 1 | Fragmin | |||||||
| Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe | Injection | 10 | 1 | Fragmin | |||||||
Danazol | Capsule 100 mg | Oral | 100 | 5 | Azol 100 | |||||||
| Capsule 200 mg | Oral | 100 | 5 | Azol 200 | |||||||
Dantrolene | Capsule containing dantrolene sodium 25 mg | Oral | 100 | 2 | Dantrium | |||||||
| Capsule containing dantrolene sodium 50 mg | Oral | 100 | 2 | Dantrium | |||||||
Dapsone | Tablet 25 mg | Oral | 100 | 1 | Link Medical Products Pty Ltd | |||||||
| Tablet 100 mg | Oral | 100 | 1 | Link Medical Products Pty Ltd | |||||||
Dasatinib | Tablet 20 mg | Oral | 60 | 2 | Sprycel | |||||||
| Tablet 50 mg | Oral | 60 | 2 | Sprycel | |||||||
| Tablet 70 mg | Oral | 60 | 2 | Sprycel | |||||||
Desmopressin | Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle | Nasal | 5 | 5 | Minirin | |||||||
| Tablet containing desmopressin acetate 200 micrograms | Oral | 30 | 5 | Minirin | |||||||
| Wafer 120 micrograms (as acetate) | Sublingual | 30 | 5 | Minirin Melt | |||||||
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL | Nasal | 1 | 5 | Minirin Nasal Spray | |||||||
Desvenlafaxine | Tablet (extended release) 50 mg (as succinate) Tablet (extended release) 100 mg (as succinate) | Oral Oral | 28 28 | 5 5 | Pristiq Pristiq | |||||||
Dexamethasone | Tablet 500 micrograms | Oral | 30 | 4 | Dexmethsone | |||||||
| Tablet 4 mg | Oral | 30 | 4 | Dexmethsone | |||||||
| Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
| Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL | Injection | 5 | 1 | Hospira Pty Limited | |||||||
| Eye drops 1 mg per mL, 5 mL | Application to the eye | 1 | 2 | Maxidex | |||||||
Dexamethasone with Framycetin and Gramicidin | Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL | Application to the ear | 1 | 2 | Otodex Sofradex | |||||||
Dexamphetamine | Tablet containing dexamphetamine sulfate 5 mg | Oral | 100 | 5 | Sigma Pharmaceuticals (Australia) Pty Ltd | |||||||
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 | |||||||
|
|
|
|
| Valium | |||||||
|
|
|
|
| Valpam 2 | |||||||
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 | |||||||
|
|
|
|
| Diazepam-DP | |||||||
|
|
|
|
| Diazepam-GA | |||||||
|
|
|
|
| Ranzepam | |||||||
|
|
|
|
| Valium | |||||||
|
|
|
|
| Valpam 5 | |||||||
| Injection 10 mg in 2 mL ampoule | Injection | 5 | .. | Hospira Pty Limited | |||||||
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | 3 | APO-Diclofenac | |||||||
|
|
|
|
| Chem mart Diclofenac | |||||||
|
|
|
|
| Clonac 25 | |||||||
|
|
|
|
| Diclofenac-GA | |||||||
|
|
|
|
| Diclohexal | |||||||
|
|
|
|
| Fenac 25 | |||||||
|
|
|
|
| Terry White Chemists Diclofenac | |||||||
|
|
|
|
| Voltaren 25 | |||||||
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | 3 | Chem mart Diclofenac | |||||||
|
|
|
|
| Clonac 50 | |||||||
|
|
|
|
| Diclofenac-GA | |||||||
|
|
|
|
| Diclohexal | |||||||
|
|
|
|
| Fenac | |||||||
|
|
|
|
| GenRx Diclofenac | |||||||
|
|
|
|
| Terry White Chemists Diclofenac | |||||||
|
|
|
|
| Voltaren 50 | |||||||
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | 3 | Voltaren 100 | |||||||
Dicloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Dicloxsig Distaph 250 | |||||||
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Diclocil Dicloxsig Distaph 500 | |||||||
Digoxin | Tablet 62.5 micrograms | Oral | 200 | 1 | Lanoxin-PG Sigmaxin-PG | |||||||
| Tablet 250 micrograms | Oral | 100 | 1 | Lanoxin Sigmaxin | |||||||
| Paediatric oral solution 50 micrograms per mL, 60 mL | Oral | 2 | 3 | Lanoxin | |||||||
Dihydroergotamine | Injection containing dihydroergotamine mesylate 1 mg in 1 mL | Injection | 5 | .. | Dihydergot | |||||||
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Oral | 90 | 5 | Cardizem | |||||||
|
|
|
|
| Chem mart Diltiazem | |||||||
|
|
|
|
| Coras | |||||||
|
|
|
|
| Diltahexal | |||||||
|
|
|
|
| Dilzem 60 mg | |||||||
|
|
|
|
| GenRx Diltiazem | |||||||
|
|
|
|
| Terry White Chemists Diltiazem | |||||||
|
|
|
|
| Vasocardol | |||||||
| Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg | Oral | 30 | 5 | Cardizem CD | |||||||
|
|
|
|
| Chem mart Diltiazem CD | |||||||
|
|
|
|
| Diltahexal CD | |||||||
|
|
|
|
| Dilzem CD | |||||||
|
|
|
|
| GenRx Diltiazem CD | |||||||
|
|
|
|
| Terry White Chemists Diltiazem CD | |||||||
|
|
|
|
| Vasocardol CD | |||||||
| Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg | Oral | 30 | 5 | Cardizem CD | |||||||
|
|
|
|
| Chem mart Diltiazem CD | |||||||
|
|
|
|
| Diltahexal CD | |||||||
|
|
|
|
| Dilzem CD | |||||||
|
|
|
|
| GenRx Diltiazem CD | |||||||
|
|
|
|
| Terry White Chemists Diltiazem CD | |||||||
|
|
|
|
| Vasocardol CD | |||||||
| Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg | Oral | 30 | 5 | Cardizem CD Diltahexal CD Vasocardol CD | |||||||
Diphenoxylate with Atropine | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms | Oral | 20 | .. | Lofenoxal Lomotil | |||||||
Diphtheria and tetanus vaccine, adsorbed, diluted for adult use | Injection 0.5 mL in pre-filled syringe | Injection | 5 | .. | ADT Booster | |||||||
Dipyridamole | Capsule 200 mg (sustained release) | Oral | 60 | 5 | Persantin SR | |||||||
Dipyridamole with Aspirin | Capsule 200 mg (sustained release)-25 mg | Oral | 60 | 5 | Asasantin SR | |||||||
Disopyramide | Capsule 100 mg | Oral | 100 | 5 | Rythmodan | |||||||
| Capsule 150 mg | Oral | 100 | 5 | Rythmodan | |||||||
Docetaxel | Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL | Injection | 1 | .. | Taxotere | |||||||
| Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL | Injection | 1 | .. | Taxotere | |||||||
Dolasetron | Tablet containing dolasetron mesylate 200 mg | Oral | 2 | .. | Anzemet | |||||||
| I.V. injection containing dolasetron mesylate 100 mg in 5 mL | Injection | 1 | .. | Anzemet | |||||||
Domperidone | Tablet 10 mg | Oral | 25 | .. | Motilium | |||||||
Donepezil | Tablet containing donepezil hydrochloride 5 mg | Oral | 28 | 5 | Aricept | |||||||
| Tablet containing donepezil hydrochloride 10 mg | Oral | 28 | 5 | Aricept | |||||||
Dorzolamide | Eye drops 20 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Trusopt | |||||||
Dorzolamide with Timolol | Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Cosopt | |||||||
Dothiepin | Capsule containing dothiepin hydrochloride 25 mg | Oral | 50 | 2 | Dothep 25 Prothiaden | |||||||
| Tablet containing dothiepin hydrochloride 75 mg | Oral | 30 | 2 | Dothep 75 Prothiaden | |||||||
Doxepin | Tablet 50 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 50 | |||||||
| Capsule 10 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 10 Sinequan | |||||||
| Capsule 25 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 25 Sinequan | |||||||
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial | Injection/intravesical | 4 | .. | Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited | |||||||
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial | Injection/intravesical | 4 | .. | Adriamycin Solution | |||||||
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial | Injection/intravesical | 3 | .. | Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited | |||||||
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial | Injection/intravesical | 1 | .. | Doxorubicin Ebewe | |||||||
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Injection/intravesical | 1 | .. | Adriamycin Doxorubicin Ebewe | |||||||
Doxorubicin - Pegylated Liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Injection | 1 | .. | Caelyx | |||||||
| Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL | Injection | 1 | .. | Caelyx | |||||||
Doxycycline | Tablet 100 mg (as monohydrate) | Oral | 7 | 1 | Chem mart Doxycycline | |||||||
|
|
|
|
| Doxyhexal | |||||||
|
|
|
|
| GenRx Doxycycline | |||||||
|
|
|
|
| Terry White Chemists Doxycycline | |||||||
| Tablet 100 mg (as hydrochloride) | Oral | 7 | 1 | Doxsig | |||||||
|
|
|
|
| Doxy-100 | |||||||
|
|
|
|
| Doxylin 100 | |||||||
|
|
|
|
| Vibramycin | |||||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 7 | 1 | DBL Doxycycline Doryx | |||||||
| Tablet 50 mg (as monohydrate) | Oral | 25 | 5 | Chem mart Doxycycline | |||||||
|
|
|
|
| Doxyhexal | |||||||
|
|
|
|
| Frakas | |||||||
|
|
|
|
| GenRx Doxycycline | |||||||
|
|
|
|
| Terry White Chemists Doxycycline | |||||||
| Tablet 50 mg (as hydrochloride) | Oral | 25 | 5 | Doxy-50 Doxylin 50 Vibra-Tabs | |||||||
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 25 | 5 | DBL Doxycycline Doryx | |||||||
Drotrecogin Alfa (activated) | Powder for I.V. infusion 5 mg | Injection | 1 | .. | Xigris | |||||||
Duloxetine | Capsule 30 mg (as hydrochloride) | Oral | 28 | .. | Cymbalta | |||||||
| Capsule 60 mg (as hydrochloride) | Oral | 28 | 5 | Cymbalta | |||||||
Dydrogesterone | Tablet 10 mg | Oral | 28 | 2 | Duphaston | |||||||
Eformoterol | Capsule containing powder for oral inhalation containing eformoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer) | Inhalation by mouth | 60 | 5 | Foradile | |||||||
| Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Oxis Turbuhaler | |||||||
| Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Oxis Turbuhaler | |||||||
Electrolyte Replacement, Oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | Oral | 1 | .. | O.R.S. Repalyte New Formulation restore O.R.S. | |||||||
Electrolyte Replacement, Solution | Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L | Injection | 2 | 1 | Plasma-Lyte 148 | |||||||
Enalapril | Tablet containing enalapril maleate 5 mg | Oral | 30 | 5 | Alphapril | |||||||
|
|
|
|
| Auspril | |||||||
|
|
|
|
| Chem mart Enalapril | |||||||
|
|
|
|
| Enahexal | |||||||
|
|
|
|
| Enalabell | |||||||
|
|
|
|
| Enalapril-DP 5mg | |||||||
|
|
|
|
| Enalapril generichealth | |||||||
|
|
|
|
| Enalapril Winthrop | |||||||
|
|
|
|
| GenRx Enalapril | |||||||
|
|
|
|
| Renitec M | |||||||
|
|
|
|
| Terry White Chemists Enalapril | |||||||
| Tablet containing enalapril maleate 10 mg | Oral | 30 | 5 | Alphapril | |||||||
|
|
|
|
|
| |||||||
|
|
|
|
| Auspril | |||||||
|
|
|
|
| Chem mart Enalapril | |||||||
|
|
|
|
| Enahexal | |||||||
|
|
|
|
| Enalabell | |||||||
|
|
|
|
| Enalapril-DP 10mg | |||||||
|
|
|
|
| Enalapril generichealth | |||||||
|
|
|
|
| Enalapril Winthrop | |||||||
|
|
|
|
| GenRx Enalapril | |||||||
|
|
|
|
| Renitec | |||||||
|
|
|
|
| Terry White Chemists Enalapril | |||||||
| Tablet containing enalapril maleate 20 mg | Oral | 30 | 5 | Alphapril | |||||||
|
|
|
|
| Auspril | |||||||
|
|
|
|
| Chem mart Enalapril | |||||||
|
|
|
|
| Enahexal | |||||||
|
|
|
|
| Enalabell | |||||||
|
|
|
|
| Enalapril-DP 20mg | |||||||
|
|
|
|
| Enalapril generichealth | |||||||
|
|
|
|
| GenRx Enalapril | |||||||
|
|
|
|
| Renitec 20 | |||||||
|
|
|
|
| Terry White Chemists Enalapril | |||||||
Enalapril with Hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg | Oral | 30 | 5 | Enalapril/HCT Sandoz Renitec Plus 20/6 | |||||||
Enoxaparin | Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe | Injection | 20 | . . | Clexane | |||||||
| Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe | Injection | 20 | . . | Clexane | |||||||
| Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL | Injection | 20 | . . | Clexane | |||||||
| Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe | Injection | 10 | 1 | Clexane | |||||||
| Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe | Injection | 10 | 1 | Clexane | |||||||
| Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe | Injection | 10 | 1 | Clexane | |||||||
Entacapone | Tablet 200 mg | Oral | 200 | 4 | Comtan | |||||||
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Injection/intravesical | 4 | .. | Epirubicin Ebewe Pharmorubicin Solution | |||||||
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Injection/intravesical | 4 | .. | Pharmorubicin Solution | |||||||
| Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Injection/intravesical | 4 | .. | Epirubicin Ebewe Hospira Pty Limited Pharmorubicin Solution | |||||||
| Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL | Injection/intravesical | 2 | .. | Epirubicin Ebewe Hospira Pty Limited | |||||||
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Injection/intravesical | 1 | .. | Epirubicin Ebewe | |||||||
Eplerenone | Tablet 25 mg | Oral | 30 | 5 | Inspra | |||||||
| Tablet 50 mg | Oral | 30 | 5 | Inspra | |||||||
Eprosartan | Tablet 400 mg (as mesylate) | Oral | 56 | 5 | Teveten | |||||||
| Tablet 600 mg (as mesylate) | Oral | 28 | 5 | Teveten | |||||||
Eprosartan with Hydrochlorothiazide | Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide | Oral | 28 | 5 | Teveten Plus 600/12.5 | |||||||
Eptifibatide | Solution for I.V. injection 20 mg (as acetate) in 10 mL | Injection | 2 | .. | Integrilin | |||||||
| Solution for I.V. infusion 75 mg (as acetate) in 100 mL | Injection | 3 | .. | Integrilin | |||||||
Erlotinib | Tablet 25 mg (as hydrochloride) | Oral | 30 | 3 | Tarceva | |||||||
| Tablet 100 mg (as hydrochloride) | Oral | 30 | 3 | Tarceva | |||||||
| Tablet 150 mg (as hydrochloride) | Oral | 30 | 3 | Tarceva | |||||||
Erythromycin | Tablet 400 mg (as ethyl succinate) | Oral | 25 | 1 | E.E.S. 400 Filmtab E-Mycin | |||||||
| Capsule 250 mg (containing enteric coated pellets) | Oral | 25 | 1 | DBL Erythromycin Eryc | |||||||
| Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | 1 | E.E.S. 200 E-Mycin 200 | |||||||
| Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | 1 | E.E.S. Granules E-Mycin 400 | |||||||
| Powder for I.V. infusion 1 g (as lactobionate) | Injection | 5 | .. | Erythrocin-I.V. | |||||||
Escitalopram | Tablet 10 mg (as oxalate) | Oral | 28 | 5 | APO-Escitalopram Chem mart Escitalopram Esipram Esitalo Lexam 10 Lexapro LoxaLate Terry White Chemists Escitalopram | |||||||
| Tablet 20 mg (as oxalate) | Oral | 28 | 5 | APO-Escitalopram Chem mart Escitalopram Esipram Esitalo Lexam 20 Lexapro LoxaLate Terry White Chemists Escitalopram | |||||||
| Oral solution 10 mg (as oxalate) per mL, 28 mL | Oral | 1 | 5 | Lexapro | |||||||
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) | Oral | 30 | 1 | Nexium | |||||||
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) | Oral | 30 | 1 | Nexium | |||||||
Esomeprazole and Clarithromycin and Amoxycillin | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | 1 | .. | Nexium Hp7 | |||||||
Essential amino acids formula with minerals and vitamin C | Oral powder 400 g (Dialamine) | Oral | 5 | 5 | Dialamine | |||||||
Essential amino acids formula with vitamins and minerals | Sachets containing oral powder 12.5 g, 50 (EAA Supplement) | Oral | 4 | 5 | EAA Supplement | |||||||
Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Injection | 2 | 3 | Enbrel | |||||||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | 1 | 3 | Enbrel | |||||||
| Injection 50 mg in 1 mL single use auto-injector, 4 | Injection | 1 | 3 | Enbrel | |||||||
Ethacrynic Acid | Tablet 25 mg | Oral | 200 | 1 | Edecrin | |||||||
Ethosuximide | Capsule 250 mg | Oral | 200 | 2 | Zarontin | |||||||
| Oral solution 250 mg per 5 mL, 200 mL | Oral | 1 | 5 | Zarontin | |||||||
Etidronic Acid | Tablet containing disodium etidronate 200 mg | Oral | 60 | 5 | Didronel | |||||||
Etidronic Acid and Calcium | Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium 500 mg (as carbonate) | Oral | 1 | 1 | Didrocal | |||||||
Etonogestrel | Subcutaneous implant 68 mg | Implantation | 1 | .. | Implanon | |||||||
Etoposide | Capsule 50 mg | Oral | 20 | .. | Vepesid | |||||||
| Capsule 100 mg | Oral | 10 | .. | Vepesid | |||||||
| Solution for I.V. infusion 100 mg in 5 mL vial | Injection | 5 | .. | Etoposide Ebewe Hospira Pty Limited | |||||||
| Powder for I.V. infusion 100 mg (as phosphate) | Injection | 5 | .. | Etopophos | |||||||
| Powder for I.V. infusion 1 g (as phosphate) | Injection | 1 | .. | Etopophos | |||||||
Everolimus | Tablet 0.25 mg | Oral | 60 | 3 | Certican | |||||||
| Tablet 0.5 mg | Oral | 60 | 3 | Certican | |||||||
| Tablet 0.75 mg | Oral | 120 | 3 | Certican | |||||||
Exemestane | Tablet 25 mg | Oral | 30 | 5 | Aromasin | |||||||
Ezetimibe | Tablet 10 mg | Oral | 30 | 5 | Ezetrol | |||||||
Ezetimibe with Simvastatin | Tablet 10 mg-10 mg | Oral | 30 | 5 | Vytorin | |||||||
| Tablet 10 mg-20 mg | Oral | 30 | 5 | Vytorin | |||||||
| Tablet 10 mg-40 mg | Oral | 30 | 5 | Vytorin | |||||||
| Tablet 10 mg-80 mg | Oral | 30 | 5 | Vytorin | |||||||
Famciclovir | Tablet 125 mg | Oral | 40 | 1 | Famvir | |||||||
| Tablet 250 mg | Oral | 20 | 1 | Famvir | |||||||
| Tablet 500 mg | Oral | 30 | .. | Famvir | |||||||
Famotidine | Tablet 20 mg | Oral | 60 | 5 | Ausfam 20 | |||||||
|
|
|
|
| Chem mart Famotidine | |||||||
|
|
|
|
| Famohexal | |||||||
|
|
|
|
| GenRx Famotidine | |||||||
|
|
|
|
| Pamacid 20 | |||||||
|
|
|
|
| Pepcidine M | |||||||
|
|
|
|
| Pepzan | |||||||
|
|
|
|
| Terry White Chemists Famotidine | |||||||
| Tablet 40 mg | Oral | 30 | 5 | Ausfam 40 | |||||||
|
|
|
|
| Chem mart Famotidine | |||||||
|
|
|
|
| Famohexal | |||||||
|
|
|
|
| GenRx Famotidine | |||||||
|
|
|
|
| Pamacid 40 | |||||||
|
|
|
|
| Pepcidine | |||||||
|
|
|
|
| Pepzan | |||||||
|
|
|
|
| Terry White Chemists Famotidine | |||||||
Felodipine | Tablet 2.5 mg (extended release) | Oral | 30 | 5 | Felodur ER 2.5 mg Plendil ER | |||||||
| Tablet 5 mg (extended release) | Oral | 30 | 5 | Felodil XR 5 Felodur ER 5 mg Plendil ER | |||||||
| Tablet 10 mg (extended release) | Oral | 30 | 5 | Felodil XR 10 Felodur ER 10 mg Plendil ER | |||||||
Fenofibrate | Tablet 48 mg | Oral | 60 | 5 | Lipidil | |||||||
| Tablet 145 mg | Oral | 30 | 5 | Lipidil | |||||||
Fentanyl | Transdermal patch 2.1 mg | Transdermal | 5 | .. | Durogesic 12 | |||||||
| Transdermal patch 4.2 mg | Transdermal | 5 | .. | Durogesic 25 | |||||||
| Transdermal patch 8.4 mg | Transdermal | 5 | .. | Durogesic 50 | |||||||
| Transdermal patch 12.6 mg | Transdermal | 5 | .. | Durogesic 75 | |||||||
| Transdermal patch 16.8 mg | Transdermal | 5 | .. | Durogesic 100 | |||||||
Ferrous Fumarate with Folic Acid | Tablet 310 mg (equivalent to 100 mg iron)-350 micrograms | Oral | 60 | 1 | Ferro-f-tab | |||||||
Ferrous Sulfate | Oral liquid 30 mg per mL, 250 mL | Oral | 1 | 2 | Ferro-Liquid | |||||||
Flecainide | Tablet containing flecainide acetate 50 mg | Oral | 60 | 5 | Tambocor | |||||||
| Tablet containing flecainide acetate 100 mg | Oral | 60 | 5 | Flecatab Tambocor | |||||||
Flucloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 250 | |||||||
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 500 | |||||||
| Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited | |||||||
| Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited | |||||||
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Flubiclox Flucil | |||||||
| Powder for injection 1 g (as sodium) | Injection | 5 | 1 | Flubiclox Flucil Hospira Pty Limited | |||||||
Fluconazole | Capsule 50 mg | Oral | 28 | 5 | DBL Fluconazole | |||||||
|
|
|
|
| Diflucan | |||||||
|
|
|
|
| Dizole 50 | |||||||
|
|
|
|
| Fluconazole Sandoz | |||||||
|
|
|
|
| Fluzole 50 | |||||||
|
|
|
|
| Ozole | |||||||
| Capsule 100 mg | Oral | 28 | 5 | DBL Fluconazole | |||||||
|
|
|
|
| Diflucan | |||||||
|
|
|
|
| Dizole 100 | |||||||
|
|
|
|
| Fluconazole Sandoz | |||||||
|
|
|
|
| Fluconazole Winthrop | |||||||
|
|
|
|
| Ozole | |||||||
| Capsule 200 mg | Oral | 28 | 5 | APO-Fluconazole | |||||||
|
|
|
|
| DBL Fluconazole | |||||||
|
|
|
|
| Diflucan | |||||||
|
|
|
|
| Dizole 200 | |||||||
|
|
|
|
| Fluconazole Sandoz | |||||||
|
|
|
|
| Fluconazole Winthrop | |||||||
|
|
|
|
| Fluzole 200 | |||||||
|
|
|
|
| Ozole | |||||||
| Solution for I.V. infusion 100 mg in 50 mL | Injection | 7 | .. | Diflucan Fluconazole Hexal | |||||||
| Solution for I.V. infusion 200 mg in 100 mL | Injection | 7 | .. | Baxter Healthcare Pty Ltd Diflucan Fluconazole Hexal | |||||||
| Solution for I.V. infusion 400 mg in 200 mL | Injection | 1 | .. | Baxter Healthcare Pty Ltd | |||||||
Fludarabine | Tablet containing fludarabine phosphate 10 mg | Oral | 20 | 5 | Fludara | |||||||
| Powder for I.V. injection containing fludarabine phosphate 50 mg | Injection | 5 | 3 | Fludara Fludarabine Actavis | |||||||
| Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL | Injection | 5 | 3 | Fludarabine Ebewe | |||||||
Fludrocortisone | Tablet containing fludrocortisone acetate 100 micrograms | Oral | 200 | 1 | Florinef | |||||||
Fluorometholone | Eye drops 1 mg per mL, 5 mL | Application to the eye | 1 | 5 | Flucon FML Liquifilm | |||||||
| Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL | Application to the eye | 1 | 2 | Flarex | |||||||
Fluorouracil | Injection 500 mg in 10 mL | Injection | 10 | .. | Fluorouracil Ebewe Hospira Pty Limited | |||||||
| Injection 1000 mg in 20 mL | Injection | 5 | .. | Fluorouracil Ebewe | |||||||
Fluoxetine | Tablet, dispersible, 20 mg (as hydrochloride) | Oral | 28 | 5 | Lovan 20 Tab Prozac Tab | |||||||
| Capsule 20 mg (as hydrochloride) | Oral | 28 | 5 | Auscap | |||||||
|
|
|
|
| Chem mart Fluoxetine | |||||||
|
|
|
|
| Fluohexal | |||||||
|
|
|
|
| Fluoxebell | |||||||
|
|
|
|
| Fluoxetine 20 | |||||||
|
|
|
|
| Fluoxetine-GA | |||||||
|
|
|
|
| Fluoxetine-DP | |||||||
|
|
|
|
| Fluoxetine generichealth | |||||||
|
|
|
|
| GenRx Fluoxetine | |||||||
|
|
|
|
| Lovan | |||||||
|
|
|
|
| Prozac 20 | |||||||
|
|
|
|
| Terry White Chemists Fluoxetine | |||||||
|
|
|
|
| Zactin | |||||||
Flupenthixol Decanoate | Oily I.M. injection 20 mg in 1 mL ampoule | Injection | 5 | .. | Fluanxol Depot | |||||||
| Oily I.M. injection 40 mg in 2 mL ampoule | Injection | 5 | .. | Fluanxol Depot | |||||||
| Oily I.M. injection 100 mg in 1 mL ampoule | Injection | 5 | .. | Fluanxol Concentrated Depot | |||||||
Fluphenazine Decanoate | Injection 12.5 mg in 0.5 mL ampoule | Injection | 5 | .. | Modecate | |||||||
| Injection 25 mg in 1 mL ampoule | Injection | 5 | .. | Modecate | |||||||
| Injection 50 mg in 2 mL ampoule | Injection | 5 | .. | Modecate | |||||||
Flurbiprofen | Eye drops containing flurbiprofen sodium 300 micrograms per mL, single dose units 0.4 mL, 5 | Application to the eye | 1 | .. | Ocufen | |||||||
Flutamide | Tablet 250 mg | Oral | 100 | 5 | Eulexin Flutamin | |||||||
Fluticasone | Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Flixotide Junior | |||||||
| Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Flixotide | |||||||
| Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 1 | Flixotide | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Flixotide Junior Accuhaler | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Flixotide Accuhaler | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 1 | Flixotide Accuhaler | |||||||
Fluticasone with Salmeterol | Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 50/25 | |||||||
| Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 125/25 | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 100/50 | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 250/50 | |||||||
| Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 250/25 | |||||||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 500/50 | |||||||
Fluvastatin | Capsule 20 mg (as sodium) | Oral | 28 | 5 | Lescol Vastin | |||||||
| Capsule 40 mg (as sodium) | Oral | 28 | 5 | Lescol Vastin | |||||||
| Tablet (prolonged release) 80 mg (as sodium) | Oral | 28 | 5 | Lescol XL | |||||||
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Oral | 30 | 5 | APO-Fluvoxamine | |||||||
|
|
|
|
| Faverin 50 | |||||||
|
|
|
|
| Luvox | |||||||
|
|
|
|
| Movox 50 | |||||||
|
|
|
|
| Voxam | |||||||
| Tablet containing fluvoxamine maleate 100 mg | Oral | 30 | 5 | APO-Fluvoxamine | |||||||
|
|
|
|
| Faverin 100 | |||||||
|
|
|
|
| Luvox | |||||||
|
|
|
|
| Movox 100 | |||||||
|
|
|
|
| Voxam | |||||||
Folic Acid | Tablet 500 micrograms | Oral | 200 | .. | Megafol 0.5 | |||||||
| Tablet 5 mg | Oral | 200 | 1 | Megafol 5 | |||||||
Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid | Oral | 10 | .. | Leucovorin Calcium (Hospira Pty Limited) | |||||||
| Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Injection | 5 | 5 | Calcium Folinate Ebewe Leucovorin Calcium (Hospira Pty Limited) Leucovorin Calcium (Pfizer Australia Pty Ltd) | |||||||
| Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Injection | 10 | 1 | Calcium Folinate Ebewe Leucovorin Calcium (Pfizer Australia Pty Ltd) | |||||||
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | 4 | 1 | Leucovorin Calcium (Hospira Pty Limited) | |||||||
Follitropin Alfa | Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL | Injection | 5 | 5 | Gonal-f 75 | |||||||
| Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL | Injection | 1 | 5 | Gonal-f 75 | |||||||
| Injection 300 I.U. in 0.5 mL multi-dose cartridge | Injection | 3 | 5 | Gonal-f Pen | |||||||
| Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL | Injection | 3 | 5 | Gonal-f | |||||||
| Injection 450 I.U. in 0.75 mL multi-dose cartridge | Injection | 3 | 5 | Gonal-f Pen | |||||||
| Injection 900 I.U. in 1.5 mL multi-dose cartridge | Injection | 2 | 5 | Gonal-f Pen | |||||||
| Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL | Injection | 1 | 5 | Gonal-f | |||||||
Follitropin Beta | Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge | Injection | 3 | 5 | Puregon 300 IU/0.36 mL | |||||||
| Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge | Injection | 2 | 5 | Puregon 600 IU/0.72 mL | |||||||
| Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge | Injection | 2 | 5 | Puregon 900 IU/1.08 mL | |||||||
Fondaparinux | Injection containing fondaparinux sodium 2.5 mg in 0.5 mL single dose pre-filled syringe | Injection | 7 | .. | Arixtra | |||||||
Fosinopril | Tablet containing fosinopril sodium 10 mg | Oral | 30 | 5 | Fosinopril Sandoz | |||||||
|
|
|
|
| Fosipril 10 | |||||||
|
|
|
|
| GenRx Fosinopril | |||||||
|
|
|
|
| Monace 10 | |||||||
|
|
|
|
| Monopril | |||||||
| Tablet containing fosinopril sodium 20 mg | Oral | 30 | 5 | Fosinopril Sandoz | |||||||
|
|
|
|
| Fosipril 20 | |||||||
|
|
|
|
| GenRx Fosinopril | |||||||
|
|
|
|
| Monace 20 | |||||||
|
|
|
|
| Monopril | |||||||
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | APO-Fosinopril HCTZ 10/12.5 | |||||||
|
|
|
|
| Fosinopril/HCT Sandoz 10mg/12.5mg | |||||||
|
|
|
|
| Hyforil | |||||||
|
|
|
|
| Monoplus 10/12.5 | |||||||
| Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | APO-Fosinopril HCTZ 20/12.5 | |||||||
|
|
|
|
| Fosetic 20/12.5 | |||||||
|
|
|
|
| Fosinopril/HCT Sandoz 20mg/12.5mg | |||||||
|
|
|
|
| Hyforil | |||||||
|
|
|
|
| Monoplus 20/12.5 | |||||||
Fotemustine | Powder for injection 208 mg with solvent | Injection | 1 | 4 | Muphoran | |||||||
Framycetin | Eye or ear drops containing framycetin sulfate 5 mg per mL, 8 mL | Application to the eye/ear | 1 | 2 | Soframycin | |||||||
Frusemide | Tablet 20 mg | Oral | 100 | 1 | Chem mart Frusemide | |||||||
|
|
|
|
| Frusid | |||||||
|
|
|
|
| GenRx Frusemide | |||||||
|
|
|
|
| Lasix-M | |||||||
|
|
|
|
| Terry White Chemists Frusemide | |||||||
|
|
|
|
| Urex-M | |||||||
| Tablet 40 mg | Oral | 100 | 1 | Chem mart Frusemide | |||||||
|
|
|
|
| Frusehexal 40 mg | |||||||
|
|
|
|
| Frusid | |||||||
|
|
|
|
| GenRx Frusemide | |||||||
|
|
|
|
| Lasix | |||||||
|
|
|
|
| Terry White Chemists Frusemide | |||||||
|
|
|
|
| Uremide | |||||||
|
|
|
|
| Urex | |||||||
| Tablet 500 mg | Oral | 50 | 3 | Urex-Forte | |||||||
| Oral solution 10 mg per mL, 30 mL | Oral | 1 | 3 | Lasix | |||||||
| Injection 20 mg in 2 mL | Injection | 5 | .. | Frusehexal Frusemide-Claris Lasix | |||||||
Fusidic Acid | Tablet containing sodium fusidate 250 mg | Oral | 36 | 1 | Fucidin | |||||||
Gabapentin | Capsule 100 mg | Oral | 100 | 5 | APO-Gabapentin | |||||||
|
|
|
|
| DBL Gabapentin | |||||||
|
|
|
|
| Gabatine 100 | |||||||
|
|
|
|
| Gantin | |||||||
|
|
|
|
| Neurontin | |||||||
|
|
|
|
| Nupentin 100 | |||||||
| Capsule 300 mg | Oral | 100 | 5 | DBL Gabapentin | |||||||
|
|
|
|
| Douglas Gabapentin 300mg | |||||||
|
|
|
|
| Gabahexal 300mg | |||||||
|
|
|
|
| Gabapentin 300 | |||||||
|
|
|
|
| Gabapentin-GA | |||||||
|
|
|
|
| Gabatine 300 | |||||||
|
|
|
|
| Gantin | |||||||
|
|
|
|
| GenRx Gabapentin | |||||||
|
|
|
|
| Neurontin | |||||||
|
|
|
|
| Nupentin 300 | |||||||
| Capsule 400 mg | Oral | 100 | 5 | DBL Gabapentin | |||||||
|
|
|
|
| Douglas Gabapentin 400mg | |||||||
|
|
|
|
| Gabahexal 400mg | |||||||
|
|
|
|
| Gabapentin 400 | |||||||
|
|
|
|
| Gabatine 400 | |||||||
|
|
|
|
| Gantin | |||||||
|
|
|
|
| GenRx Gabapentin | |||||||
|
|
|
|
| Neurontin | |||||||
|
|
|
|
| Nupentin 400 | |||||||
|
|
|
|
| Pendine 400 | |||||||
| Tablet 600 mg | Oral | 100 | 5 | Gabahexal 600mg | |||||||
|
|
|
|
| Gabaran | |||||||
|
|
|
|
| GenRx Gabapentin | |||||||
|
|
|
|
| Neurontin | |||||||
| Tablet 800 mg | Oral | 100 | 5 | Gabaran | |||||||
|
|
|
|
| Gantin | |||||||
|
|
|
|
| GenRx Gabapentin | |||||||
|
|
|
|
| Neurontin | |||||||
|
|
|
|
| Pendine 800 | |||||||
Galantamine | Capsule (prolonged release) 8 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl | |||||||
| Capsule (prolonged release) 16 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl | |||||||
| Capsule (prolonged release) 24 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl | |||||||
Gefitinib | Tablet 250 mg | Oral | 30 | 1 | Iressa | |||||||
Gelatin - Succinylated | I.V. infusion 20 g per 500 mL, 500 mL | Injection | 3 | .. | Gelofusine | |||||||
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) | Injection | 4 | 2 | DBL Gemcitabine for Injection Gemcitabine Actavis Gemcitabine Ebewe Gemcite Gemzar | |||||||
| Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL | Injection | 4 | 2 | Gemcitabine Ebewe | |||||||
| Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL | Injection | 4 | 2 | Gemcitabine Ebewe | |||||||
| Powder for I.V. infusion 1 g (as hydrochloride) | Injection | 2 | 2 | DBL Gemcitabine for Injection Gemcitabine Actavis Gemcitabine Ebewe Gemcite Gemzar | |||||||
| Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL | Injection | 2 | 2 | Gemcitabine Ebewe | |||||||
| Powder for I.V. infusion 2 g (as hydrochloride) | Injection | 1 | 2 | DBL Gemcitabine for Injection | |||||||
Gemfibrozil | Tablet 600 mg | Oral | 60 | 5 | Ausgem | |||||||
|
|
|
|
| Chem mart Gemfibrozil | |||||||
|
|
|
|
| Gemhexal | |||||||
|
|
|
|
| GenRx Gemfibrozil | |||||||
|
|
|
|
| Jezil | |||||||
|
|
|
|
| Lipazil 600 mg | |||||||
|
|
|
|
| Lopid | |||||||
|
|
|
|
| Pharmacor Gemfibrozil 600 | |||||||
|
|
|
|
| Terry White Chemists Gemfibrozil | |||||||
Gentamicin | Injection 80 mg (as sulfate) in 2 mL | Injection | 10 | 1 | Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
| Eye drops 3 mg (as sulfate) per mL, 5 mL | Application to the eye | 1 | 2 | Genoptic | |||||||
Gestrinone | Capsule 2.5 mg | Oral | 8 | 5 | Dimetriose | |||||||
Glatiramer | Injection containing glatiramer acetate 20 mg in 1 mL single dose pre-filled syringe | Injection | 28 | 5 | Copaxone | |||||||
Glibenclamide | Tablet 5 mg | Oral | 100 | 5 | Daonil Glimel | |||||||
Gliclazide | Tablet 30 mg (modified release) | Oral | 100 | 5 | APO-Gliclazide MR Chem mart Gliclazide MR Diamicron MR Glyade MR Oziclide MR Terry White Chemists Gliclazide MR | |||||||
| Tablet 60 mg (modified release) | Oral | 60 | 5 | Diamicron 60mg MR | |||||||
| Tablet 80 mg | Oral | 100 | 5 | Chem mart Gliclazide | |||||||
|
|
|
|
| GenRx Gliclazide | |||||||
|
|
|
|
| Glyade | |||||||
|
|
|
|
| Mellihexal | |||||||
|
|
|
|
| Nidem | |||||||
|
|
|
|
| Terry White Chemists Gliclazide | |||||||
Glimepiride | Tablet 1 mg | Oral | 30 | 5 | Amaryl | |||||||
|
|
|
|
| APO-Glimepiride | |||||||
|
|
|
|
| Aylide 1 | |||||||
|
|
|
|
| Diapride 1 | |||||||
|
|
|
|
| Dimirel | |||||||
|
|
|
|
| Glimepiride Sandoz | |||||||
| Tablet 2 mg | Oral | 30 | 5 | Amaryl | |||||||
|
|
|
|
| APO-Glimepiride | |||||||
|
|
|
|
| Aylide 2 | |||||||
|
|
|
|
| Diapride 2 | |||||||
|
|
|
|
| Dimirel | |||||||
|
|
|
|
| Glimepiride Sandoz | |||||||
| Tablet 3 mg | Oral | 30 | 5 | Amaryl | |||||||
|
|
|
|
| APO-Glimepiride | |||||||
|
|
|
|
| Aylide 3 | |||||||
|
|
|
|
| Diapride 3 | |||||||
|
|
|
|
| Dimirel | |||||||
|
|
|
|
| Glimepiride Sandoz | |||||||
| Tablet 4 mg | Oral | 30 | 5 | Amaryl | |||||||
|
|
|
|
| APO-Glimepiride | |||||||
|
|
|
|
| Aylide 4 | |||||||
|
|
|
|
| Diapride 4 | |||||||
|
|
|
|
| Dimirel | |||||||
|
|
|
|
| Glimepiride Sandoz | |||||||
Glipizide | Tablet 5 mg | Oral | 100 | 5 | Melizide Minidiab | |||||||
Glucagon | Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe | Injection | 1 | 1 | GlucaGen Hypokit | |||||||
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL | Injection | 5 | 1 | B. Braun Australia Pty Ltd | |||||||
|
|
|
|
| Glucose 5% Freeflex | |||||||
| I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited | |||||||
| I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | Pharmatel Fresenius Kabi Pty Limited | |||||||
| I.V. infusion 278 mmol (anhydrous) per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Ltd | |||||||
|
|
|
|
| B. Braun Australia Pty Ltd | |||||||
|
|
|
|
| Pharmatel Fresenius Kabi Pty Limited | |||||||
Glucose and Ketone Indicator—Urine | Test strips, 50 (Keto-Diabur-Test 5000) | For external use | 2 | 2 | Keto-Diabur- Test 5000 | |||||||
| Test strips, 50 (Keto-Diastix) | For external use | 2 | 2 | Keto-Diastix | |||||||
Glucose Indicator—Blood | Test strips, 25 (On-Call Plus) | For external use | 4 | 5 | On-Call Plus | |||||||
| Test strips, 50 (Accu-Chek Active) | For external use | 2 | 5 | Accu-Chek Active | |||||||
| Test strips, 50 (Accu-Chek Go) | For external use | 2 | 5 | Accu-Chek Go | |||||||
| Test strips, 51 (Accu-Chek Integra) | For external use | 2 | 5 | Accu-Chek Integra | |||||||
| Test strips, 50 (Accu-Chek Mobile) | For external use | 2 | 5 | Accu-Chek Mobile | |||||||
| Test strips, 50 (Advantage II) | For external use | 2 | 5 | Advantage II | |||||||
| Test strips, 50 (Betachek) | For external use | 2 | 5 | Betachek | |||||||
| Test strips, 50 (Betachek G5) | For external use | 2 | 5 | Betachek G5 | |||||||
| Test strips, 50 (Bionime Rightest) | For external use | 2 | 5 | Bionime Rightest | |||||||
| Test strips, 50 (CareSens) | For external use | 2 | 5 | CareSens | |||||||
| Test strips, 50 (FreeStyle) | For external use | 2 | 5 | FreeStyle | |||||||
| Test strips, 50 (Freestyle Papillon) | For external use | 2 | 5 | Freestyle Papillon | |||||||
| Test strips, 50 (Glucocard 01 Sensor) | For external use | 2 | 5 | Glucocard 01 Sensor | |||||||
| Test strips, 50 (Glucoflex-R) | For external use | 2 | 5 | Glucoflex-R | |||||||
| Test strips, 50 (GlucoOz) | For external use | 2 | 5 | GlucoOz | |||||||
| Test strips, 50 (Glucostix) | For external use | 2 | 5 | Glucostix | |||||||
| Test strips, 50 (Lifeline Attest) | For external use | 2 | 5 | Lifeline Attest | |||||||
| Test strips, 50 (MWD Pen Sensor Strips) | For external use | 2 | 5 | MWD Pen Sensor Strips | |||||||
| Test strips, 50 (MyGlucoHealth) | For external use | 2 | 5 | MyGlucoHealth | |||||||
| Test strips, 50 (Omnitest EZ) | For external use | 2 | 5 | Omnitest EZ | |||||||
| Test strips, 50 (Omnitest Plus) | For external use | 2 | 5 | Omnitest Plus | |||||||
| Test strips, 50 (Optium Omega) | For external use | 2 | 5 | Optium Omega | |||||||
| Test strips, 50 (SensoCard) | For external use | 2 | 5 | SensoCard | |||||||
| Test strips, 50 (TrueTrack) | For external use | 2 | 5 | TrueTrack | |||||||
| Test strips, 100 (Accu-Chek Performa) | For external use | 1 | 5 | Accu-Chek Performa | |||||||
| Test strips, 100 (FreeStyle Lite) | For external use | 1 | 5 | FreeStyle Lite | |||||||
| Test strips, 100 (Optium glucose) | For external use | 1 | 5 | Optium glucose | |||||||
| Test strips, 100 (Precision Plus) | For external use | 1 | 5 | Precision Plus | |||||||
| Test strips, 100 (SofTact) | For external use | 1 | 5 | SofTact | |||||||
Glucose Indicator—Urine | Test strips, 50 (Clinistix) | For external use | 2 | 2 | Clinistix | |||||||
| Test strips, 50 (Diastix) | For external use | 2 | 2 | Diastix | |||||||
Glycerol | Suppositories 700 mg, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd | |||||||
| Suppositories 1.4 g, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd | |||||||
| Suppositories 2.8 g, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd | |||||||
Glyceryl Trinitrate | Tablets 600 micrograms, 100 | Buccal/sublingual | 1 | 5 | Anginine Stabilised Lycinate | |||||||
| Sublingual spray (pump pack) 400 micrograms per dose, 200 doses | Sublingual | 1 | 5 | Nitrolingual Pumpspray | |||||||
| Transdermal patch 18 mg | Transdermal | 30 | 5 | Minitran 5 | |||||||
| Transdermal patch 25 mg | Transdermal | 30 | 5 | Transiderm-Nitro 25 | |||||||
| Transdermal patch 40 mg | Transdermal | 30 | 5 | Nitro-Dur 5 | |||||||
| Transdermal patch 36 mg | Transdermal | 30 | 5 | Minitran 10 | |||||||
| Transdermal patch 50 mg | Transdermal | 30 | 5 | Transiderm-Nitro 50 | |||||||
| Transdermal patch 80 mg | Transdermal | 30 | 5 | Nitro-Dur 10 | |||||||
| Transdermal patch 54 mg | Transdermal | 30 | 5 | Minitran 15 | |||||||
| Transdermal patch 120 mg | Transdermal | 30 | 5 | Nitro-Dur 15 | |||||||
Goserelin | Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe | Implantation | 1 | 5 | Zoladex Implant | |||||||
| Subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe | Implantation | 1 | 1 | Zoladex 10.8 Implant | |||||||
Goserelin and Bicalutamide | Pack containing 1 subcutaneous implant containing goserelin 3.6 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg | Implantation/oral | 1 | 5 | ZolaCos CP 3.6/50 | |||||||
| Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg | Implantation/oral | 1 | .. | ZolaCos CP 10.8/50(28) | |||||||
| Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 84 tablets bicalutamide 50 mg | Implantation/oral | 1 | 1 | ZolaCos CP 10.8/50(84) | |||||||
Granisetron | Tablet 2 mg (as hydrochloride) | Oral | 2 | .. | Kytril | |||||||
| Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | 1 | .. | Kytril | |||||||
Griseofulvin | Tablet 125 mg | Oral | 100 | 2 | Grisovin | |||||||
| Tablet 500 mg | Oral | 28 | 2 | Grisovin 500 | |||||||
Haloperidol | Tablet 500 micrograms | Oral | 100 | 5 | Serenace | |||||||
| Tablet 1.5 mg | Oral | 100 | 5 | Serenace | |||||||
| Tablet 5 mg | Oral | 50 | 5 | Serenace | |||||||
| Oral solution 2 mg per mL, 100 mL | Oral | 1 | 5 | Serenace | |||||||
| Injection 5 mg in 1 mL ampoule | Injection | 10 | .. | Serenace | |||||||
Haloperidol Decanoate | I.M. injection equivalent to 50 mg haloperidol in 1 mL ampoule | Injection | 5 | .. | Haldol decanoate | |||||||
| I.M. injection equivalent to 150 mg haloperidol in 3 mL ampoule | Injection | 5 | .. | Haldol decanoate | |||||||
Heparin | Injection 5,000 units (as sodium) in 0.2 mL | Injection | 5 | 5 | Hospira Pty Limited | |||||||
| Injection (preservative-free) 5,000 I.U. (as sodium) in 5 mL | Injection | 50 | 5 | Pfizer Australia Pty Ltd | |||||||
| Injection 35,000 units (as sodium) in 35 mL | Injection | 12 | 5 | Hospira Pty Limited | |||||||
Hexamine | Tablet containing hexamine hippurate 1 g | Oral | 100 | 5 | Hiprex | |||||||
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal) | Oral | 24 | 5 | KetoCal | |||||||
Homatropine | Eye drops containing homatropine hydrobromide 20 mg per mL, 15 mL | Application to the eye | 1 | 2 | Isopto Homatropine | |||||||
Hydralazine | Tablet containing hydralazine hydrochloride 25 mg | Oral | 200 | 2 | Alphapress 25 | |||||||
| Tablet containing hydralazine hydrochloride 50 mg | Oral | 200 | 2 | Alphapress 50 | |||||||
Hydrochlorothiazide | Tablet 25 mg | Oral | 100 | 1 | Dithiazide | |||||||
Hydrochlorothiazide with Amiloride | Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg | Oral | 100 | 1 | Moduretic | |||||||
Hydrochlorothiazide with Triamterene | Tablet 25 mg-50 mg | Oral | 100 | 1 | Hydrene 25/50 | |||||||
Hydrocortisone | Tablet 4 mg | Oral | 50 | 4 | Hysone 4 | |||||||
| Tablet 20 mg | Oral | 60 | 4 | Hysone 20 | |||||||
| Injection 100 mg (as sodium succinate) with 2 mL solvent | Injection | 2 | .. | Solu-Cortef | |||||||
| Injection 250 mg (as sodium succinate) with 2 mL solvent | Injection | 1 | .. | Solu-Cortef | |||||||
| Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g | Application to the eye | 1 | .. | Hycor | |||||||
| Eye ointment containing hydrocortisone acetate 10 mg per g, 5 g | Application to the eye | 1 | .. | Hycor | |||||||
| Cream 10 mg per g, 50 g | Application | 1 | 1 | Egocort Cream 1% | |||||||
| Cream containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | 1 | Cortic-DS 1% Sigmacort | |||||||
| Cream containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | 1 | Cortef Cortic-DS 1% Sigmacort | |||||||
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | 1 | Cortic-DS 1% Sigmacort | |||||||
| Ointment containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | 1 | Cortic-DS 1% Sigmacort | |||||||
| Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g | Rectal | 2 | 3 | Colifoam | |||||||
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg | Oral | 20 | .. | Dilaudid | |||||||
| Tablet containing hydromorphone hydrochloride 4 mg | Oral | 20 | .. | Dilaudid | |||||||
| Tablet containing hydromorphone hydrochloride 8 mg | Oral | 20 | .. | Dilaudid | |||||||
| Tablet (modified release) containing hydromorphone hydrochloride 8 mg | Oral | 10 | .. | Jurnista | |||||||
| Tablet (modified release) containing hydromorphone hydrochloride 4 mg | Oral | 10 | .. | Jurnista | |||||||
| Tablet (modified release) containing hydromorphone hydrochloride 16 mg | Oral | 10 | .. | Jurnista | |||||||
| Tablet (modified release) containing hydromorphone hydrochloride 32 mg | Oral | 10 | .. | Jurnista | |||||||
| Tablet (modified release) containing hydromorphone hydrochloride 64 mg | Oral | 10 | .. | Jurnista | |||||||
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL | Oral | 1 | .. | Dilaudid | |||||||
| Injection containing hydromorphone hydrochloride 2 mg in 1 mL | Injection | 5 | .. | Dilaudid | |||||||
| Injection containing hydromorphone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Dilaudid-HP | |||||||
| Injection containing hydromorphone hydrochloride 50 mg in 5 mL | Injection | 5 | .. | Dilaudid-HP | |||||||
| Injection containing hydromorphone hydrochloride 500 mg in 50 mL | Injection | 1 | .. | Dilaudid-HP | |||||||
Hydroxocobalamin | Injection 1 mg in 1 mL | Injection | 3 | .. | Neo-B12 | |||||||
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg | Oral | 100 | 1 | Plaquenil | |||||||
Hydroxyethyl starch 130/0.4 | I.V. infusion 30 g per 500 mL, 500 mL | Injection | 3 | .. | Voluven 6% | |||||||
Hydroxyurea | Capsule 500 mg | Oral | 100 | .. | Hydrea | |||||||
Hypromellose | Eye drops 3 mg per mL, 15 mL | Application to the eye | 1 | 5 | Genteal In a Wink Moisturising | |||||||
| Eye drops 5 mg per mL, 15 mL | Application to the eye | 1 | 5 | Methopt | |||||||
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2 mg per g, 10 g | Application to the eye | 1 | 5 | Genteal gel HPMC PAA | |||||||
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL | Application to the eye | 1 | 5 | Poly-Tears Tears Naturale | |||||||
| Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 | Application to the eye | 3 | 5 | Bion Tears | |||||||
Ibandronic acid | Tablet 50 mg (as ibandronate sodium monohydrate) | Oral | 28 | 2 | Bondronat | |||||||
Ibuprofen | Tablet 200 mg | Oral | 100 | 3 | Rafen 200 | |||||||
| Tablet 400 mg | Oral | 30 | .. | Brufen | |||||||
Idarubicin | Capsule containing idarubicin hydrochloride 5 mg | Oral | 3 | .. | Zavedos | |||||||
| Capsule containing idarubicin hydrochloride 10 mg | Oral | 3 | .. | Zavedos | |||||||
| Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial | Injection | 3 | .. | Zavedos Solution | |||||||
| Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial | Injection | 6 | .. | Zavedos Solution | |||||||
Ifosfamide | Powder for I.V. injection 1 g in single dose vial | Injection | 5 | 5 | Holoxan | |||||||
| Powder for I.V. injection 2 g in single dose vial | Injection | 5 | 5 | Holoxan | |||||||
Imatinib | Tablet 100 mg (as mesylate) | Oral | 60 | 2 | Glivec | |||||||
| Tablet 400 mg (as mesylate) | Oral | 30 | 2 | Glivec | |||||||
Imipramine | Tablet containing imipramine hydrochloride 10 mg | Oral | 50 | 2 | Tofranil 10 Tolerade 10 | |||||||
| Tablet containing imipramine hydrochloride 25 mg | Oral | 50 | 2 | Tofranil 25 Tolerade 25 | |||||||
Imiquimod | Cream 50 mg per g, 250 mg single use sachets, 12 | Application | 1 | 1 | Aldara | |||||||
Indapamide | Tablet containing indapamide hemihydrate 1.5 mg (sustained release) | Oral | 90 | 1 | Natrilix SR | |||||||
| Tablet containing indapamide hemihydrate 2.5 mg | Oral | 90 | 1 | Chem mart Indapamide | |||||||
|
|
|
|
| Dapa-Tabs | |||||||
|
|
|
|
| GenRx Indapamide | |||||||
|
|
|
|
| Indahexal | |||||||
|
|
|
|
| Insig | |||||||
|
|
|
|
| Napamide 2.5 mg | |||||||
|
|
|
|
| Natrilix | |||||||
|
|
|
|
| Terry White Chemists Indapamide | |||||||
Indomethacin | Capsule 25 mg | Oral | 100 | 3 | Arthrexin Indocid | |||||||
| Suppository 100 mg | Rectal | 40 | 3 | Indocid | |||||||
Insect Allergen Extract—Honey Bee Venom | Injection set containing 550 micrograms | Injection | 1 | .. | Albey Bee Venom | |||||||
Insect Allergen Extract—Paper Wasp Venom | Injection set containing 550 micrograms | Injection | 1 | .. | Albey Paper Wasp Venom | |||||||
Insect Allergen Extract—Yellow Jacket Venom | Injection set containing 550 micrograms | Injection | 1 | .. | Albey Yellow Jacket Venom | |||||||
Insulin Aspart | Injection (human analogue) 100 units per mL, 10 mL vial | Injection | 5 | 2 | NovoRapid | |||||||
| Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | NovoRapid FlexPen NovoRapid Penfill 3 mL | |||||||
Insulin Aspart with Insulin Aspart Protamine Suspension | Injections (human analogue), cartridges, 30 units-70 units per mL, 3 mL, 5 | Injection | 5 | 1 | NovoMix 30 FlexPen NovoMix 30 Penfill 3 mL | |||||||
Insulin Detemir | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Levemir FlexPen Levemir Penfill | |||||||
Insulin Glargine | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Lantus Lantus SoloStar | |||||||
Insulin Glulisine | Injection (human analogue) 100 units per mL, 10 mL | Injection | 5 | 2 | Apidra | |||||||
| Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Apidra SoloStar | |||||||
Insulin Isophane | Injection (bovine) 100 units per mL, 10 mL | Injection | 5 | 2 | Hypurin Isophane | |||||||
| Injection (human) 100 units per mL, 10 mL | Injection | 5 | 2 | Humulin NPH Protaphane | |||||||
| Injections (human), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humulin NPH | |||||||
|
|
|
|
| Protaphane InnoLet | |||||||
|
|
|
|
| Protaphane NovoLet 3 mL | |||||||
|
|
|
|
| Protaphane Penfill 3 mL | |||||||
Insulin Lispro | Injection (human analogue) 100 units per mL, 10 mL vial | Injection | 5 | 2 | Humalog | |||||||
| Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog Humalog KwikPen | |||||||
Insulin Lispro with Insulin Lispro Protamine Suspension | Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog Mix25 Humalog Mix25 KwikPen | |||||||
| Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog Mix50 Humalog Mix50 KwikPen | |||||||
Insulin Neutral | Injection (bovine) 100 units per mL, 10 mL | Injection | 5 | 2 | Hypurin Neutral | |||||||
| Injection (human) 100 units per mL, 10 mL | Injection | 5 | 2 | Actrapid Humulin R | |||||||
| Injections (human), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Actrapid Penfill 3 mL Humulin R | |||||||
Insulin Neutral with Insulin Isophane | Injection (human) 30 units-70 units per mL, 10 mL | Injection | 5 | 2 | Humulin 30/70 | |||||||
| Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humulin 30/70 Mixtard 30/70 InnoLet Mixtard 30/70 Penfill 3 mL | |||||||
| Injections (human), cartridges, 50 units-50 units per mL, 3 mL, 5 | Injection | 5 | 1 | Mixtard 50/50 Penfill 3 mL | |||||||
Interferon Alfa-2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | 15 | 4 | Roferon-A | |||||||
| Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | 5 | 4 | Roferon-A | |||||||
| Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | 5 | 4 | Roferon-A | |||||||
| Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | 5 | 4 | Roferon-A | |||||||
Interferon Alfa-2b | Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen | Injection | 3 | 4 | Intron A Redipen | |||||||
| Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen | Injection | 3 | 5 | Intron A Redipen | |||||||
Interferon Beta-1a | Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent | Injection | 4 | 5 | Avonex | |||||||
| Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre-filled syringe | Injection | 4 | 5 | Avonex | |||||||
| Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe | Injection | 12 | 5 | Rebif 44 | |||||||
Interferon Beta-1b | Injection set including 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent | Injection | 15 | 5 | Betaferon | |||||||
Ipratropium | Pressurised inhalation containing ipratropium bromide 21 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 2 | 5 | Atrovent | |||||||
| Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 | Inhalation | 2 | 5 | Aeron 250 | |||||||
|
|
|
|
| APO-Ipratropium | |||||||
|
|
|
|
| Atrovent | |||||||
|
|
|
|
| Ipratrin | |||||||
|
|
|
|
| Ipravent | |||||||
| Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 | Inhalation | 2 | 5 | Aeron 500 | |||||||
|
|
|
|
| APO-Ipratropium | |||||||
|
|
|
|
| Atrovent Adult | |||||||
|
|
|
|
| Ipratrin Adult | |||||||
|
|
|
|
| Ipravent | |||||||
Irbesartan | Tablet 75 mg | Oral | 30 | 5 | Avapro Karvea | |||||||
| Tablet 150 mg | Oral | 30 | 5 | Avapro Karvea | |||||||
| Tablet 300 mg | Oral | 30 | 5 | Avapro Karvea | |||||||
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg | Oral | 30 | 5 | Avapro HCT 150/12.5 Karvezide 150/12.5 | |||||||
| Tablet 300 mg-12.5 mg | Oral | 30 | 5 | Avapro HCT 300/12.5 Karvezide 300/12.5 | |||||||
| Tablet 300 mg-25 mg | Oral | 30 | 5 | Avapro HCT 300/25 Karvezide 300/25 | |||||||
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | 1 | 3 | Camptosar Hospira Pty Limited Irinotecan Actavis Irinotecan Alphapharm Irinotecan Ebewe Irinotecan Sandoz Omegapharm Irinotecan | |||||||
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | 2 | 3 | Camptosar Hospira Pty Limited Irinotecan Actavis Irinotecan Alphapharm Irinotecan Ebewe Irinotecan Sandoz Omegapharm Irinotecan | |||||||
| I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL | Injection | 1 | 3 | Camptosar Irinotecan Ebewe | |||||||
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Injection | 1 | 3 | Hospira Pty Limited Irinotecan Ebewe | |||||||
Iron Polymaltose Complex | Injection 100 mg (iron) in 2 mL ampoule | Injection | 5 | .. | Ferrosig Ferrum H | |||||||
Iron Sucrose | Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL ampoule | Injection | 5 | .. | Venofer | |||||||
Isoleucine with carbohydrate | Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine Amino Acid Supplement) | Oral | 4 | 5 | Isoleucine Amino Acid Supplement | |||||||
| Sachets of oral powder 4 g containing 1g isoleucine, 30 (Isoleucine 1000 Amino Acid Supplement) | Oral | 4 | 5 | Isoleucine 1000 Amino Acid Supplement | |||||||
Isoniazid | Tablet 100 mg | Oral | 100 | 2 | Fawns and McAllan Proprietary Limited | |||||||
Isosorbide Dinitrate | Tablet 10 mg | Oral | 200 | 2 | Sorbidin | |||||||
| Tablet 5 mg (sublingual) | Oral | 200 | 2 | Isordil Sublingual | |||||||
Isosorbide Mononitrate | Tablet 60 mg (sustained release) | Oral | 30 | 5 | Chem mart Isosorbide Mononitrate | |||||||
|
|
|
|
| Duride | |||||||
|
|
|
|
| GenRx Isosorbide Mononitrate | |||||||
|
|
|
|
| Imdur Durule | |||||||
|
|
|
|
| Imtrate 60 mg | |||||||
|
|
|
|
| Isomonit | |||||||
|
|
|
|
| Monodur 60 mg | |||||||
|
|
|
|
| Terry White Chemists Isosorbide Mononitrate | |||||||
| Tablet 120 mg (sustained release) | Oral | 30 | 5 | Imdur 120 mg Monodur 120 mg | |||||||
Isotretinoin | Capsule 10 mg | Oral | 60 | 3 | Oratane Roaccutane | |||||||
| Capsule 20 mg | Oral | 60 | 3 | GenRx Isotretinoin | |||||||
|
|
|
|
| Oratane | |||||||
|
|
|
|
| Roaccutane | |||||||
| Capsule 40 mg | Oral | 30 | 3 | Oratane | |||||||
Itraconazole | Capsule 100 mg | Oral | 60 | 5 | Sporanox | |||||||
Ivermectin | Tablet 3 mg | Oral | 4 | .. | Stromectol | |||||||
Ketoconazole | Tablet 200 mg | Oral | 10 | .. | Nizoral | |||||||
| Cream 20 mg per g, 30 g | Application | 1 | 2 | Nizoral 2% Cream | |||||||
| Shampoo 10 mg per g, 100 mL | Application | 1 | 1 | Nizoral 1% | |||||||
| Shampoo 20 mg per g, 60 mL | Application | 1 | 1 | Nizoral 2% | |||||||
Ketoprofen | Capsule 200 mg (sustained release) | Oral | 28 | 3 | Orudis SR 200 Oruvail SR | |||||||
| Suppository 100 mg | Rectal | 40 | 3 | Orudis | |||||||
Labetalol | Tablet containing labetalol hydrochloride 100 mg | Oral | 100 | 5 | Presolol 100 Trandate | |||||||
| Tablet containing labetalol hydrochloride 200 mg | Oral | 100 | 5 | Presolol 200 Trandate | |||||||
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Oral | 1 | 5 | Actilax | |||||||
|
|
|
|
| Duphalac | |||||||
|
|
|
|
| Genlac | |||||||
|
|
|
|
| GenRx Lactulose | |||||||
|
|
|
|
| Lac-Dol | |||||||
|
|
|
|
| Lactocur | |||||||
Lamotrigine | Tablet 5 mg | Oral | 56 | 5 | Lamictal | |||||||
|
|
|
|
| Lamogine | |||||||
|
|
|
|
| Seaze 5 | |||||||
| Tablet 25 mg | Oral | 56 | 5 | GenRx Lamotrigine | |||||||
|
|
|
|
| Lamictal | |||||||
|
|
|
|
| Lamidus | |||||||
|
|
|
|
| Lamogine | |||||||
|
|
|
|
| Lamotrigine-DP | |||||||
|
|
|
|
| Lamotrigine-GA | |||||||
|
|
|
|
| Lamotrigine generichealth | |||||||
|
|
|
|
| Lamotrigine Sandoz | |||||||
|
|
|
|
| Lamotrust 25 | |||||||
|
|
|
|
| Seaze 25 | |||||||
| Tablet 50 mg | Oral | 56 | 5 | GenRx Lamotrigine | |||||||
|
|
|
|
| Lamictal | |||||||
|
|
|
|
| Lamidus | |||||||
|
|
|
|
| Lamogine | |||||||
|
|
|
|
| Lamotrigine-DP | |||||||
|
|
|
|
| Lamotrigine-GA | |||||||
|
|
|
|
| Lamotrigine generichealth | |||||||
|
|
|
|
| Lamotrigine Sandoz | |||||||
|
|
|
|
| Lamotrust 50 | |||||||
|
|
|
|
| Seaze 50 | |||||||
| Tablet 100 mg | Oral | 56 | 5 | GenRx Lamotrigine | |||||||
|
|
|
|
| Lamictal | |||||||
|
|
|
|
| Lamidus | |||||||
|
|
|
|
| Lamogine | |||||||
|
|
|
|
| Lamotrigine-DP | |||||||
|
|
|
|
| Lamotrigine-GA | |||||||
|
|
|
|
| Lamotrigine generichealth | |||||||
|
|
|
|
| Lamotrigine Sandoz | |||||||
|
|
|
|
| Lamotrust 100 | |||||||
|
|
|
|
| Seaze 100 | |||||||
| Tablet 200 mg | Oral | 56 | 5 | GenRx Lamotrigine | |||||||
|
|
|
|
| Lamictal | |||||||
|
|
|
|
| Lamidus | |||||||
|
|
|
|
| Lamogine | |||||||
|
|
|
|
| Lamotrigine-DP | |||||||
|
|
|
|
| Lamotrigine-GA | |||||||
|
|
|
|
| Lamotrigine generichealth | |||||||
|
|
|
|
| Lamotrigine Sandoz | |||||||
|
|
|
|
| Lamotrust 200 | |||||||
|
|
|
|
| Seaze 200 | |||||||
Lansoprazole | Tablet 30 mg (orally disintegrating) | Oral | 28 | 1 | Zoton FasTabs | |||||||
| Capsule 15 mg | Oral | 30 | 5 | Zoton | |||||||
Lanthanum | Tablet, chewable, 500 mg (as carbonate hydrate) | Oral | 90 | 5 | Fosrenol | |||||||
| Tablet, chewable, 750 mg (as carbonate hydrate) | Oral | 90 | 5 | Fosrenol | |||||||
| Tablet, chewable, 1000 mg (as carbonate hydrate) | Oral | 90 | 5 | Fosrenol | |||||||
Lapatinib | Tablet 250 mg (as ditosylate monohydrate) | Oral | 140 | 2 | Tykerb | |||||||
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL | Application to the eye | 1 | 5 | Xalatan | |||||||
Latanoprost with Timolol | Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Xalacom | |||||||
Leflunomide | Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg | Oral | 1 | .. | Arava | |||||||
| Tablet 10 mg | Oral | 30 | 5 | Arabloc Arava | |||||||
| Tablet 20 mg | Oral | 30 | 5 | Arabloc Arava | |||||||
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Oral | 30 | 5 | Zanidip | |||||||
| Tablet containing lercanidipine hydrochloride 20 mg | Oral | 30 | 5 | Zanidip | |||||||
Lercanidipine with enalapril | Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg | Oral | 30 | 5 | Zan-Extra 10/10 | |||||||
| Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg | Oral | 30 | 5 | Zan-Extra 10/20 | |||||||
Letrozole | Tablet 2.5 mg | Oral | 30 | 5 | Femara 2.5 mg | |||||||
Leuprorelin | I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe | Injection | 1 | 5 | Lucrin Depot 7.5mg PDS | |||||||
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set | Injection | 1 | 5 | Eligard 1 month | |||||||
| I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe | Injection | 1 | 1 | Lucrin Depot 3 Month PDS | |||||||
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set | Injection | 1 | 1 | Eligard 3 month | |||||||
| I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe | Injection | 1 | 1 | Lucrin Depot 4 Month PDS | |||||||
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set | Injection | 1 | 1 | Eligard 4 month | |||||||
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set | Injection | 1 | .. | Eligard 6 month | |||||||
Levetiracetam | Tablet 250 mg | Oral | 60 | 5 | Keppra | |||||||
| Tablet 500 mg | Oral | 60 | 5 | Keppra | |||||||
| Tablet 1 g | Oral | 60 | 5 | Keppra | |||||||
| Oral solution 100 mg per mL, 300 mL | Oral | 1 | 5 | Keppra | |||||||
Levodopa with Benserazide | Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar Rapid 62.5 | |||||||
| Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar Rapid 125 | |||||||
| Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 125 | |||||||
| Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar | |||||||
| Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 62.5 | |||||||
| Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 125 | |||||||
| Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release) | Oral | 100 | 5 | Madopar HBS | |||||||
| Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar | |||||||
Levodopa with Carbidopa | Tablet 200 mg-50 mg (anhydrous) (modified release) | Oral | 100 | 5 | Sinemet CR | |||||||
| Tablet 100 mg-25 mg (anhydrous) | Oral | 100 | 5 | Kinson Sinemet 100/25 | |||||||
| Tablet 250 mg-25 mg (anhydrous) | Oral | 100 | 5 | Levohexal Sinemet | |||||||
Levodopa with Carbidopa and Entacapone | Tablet 50 mg-12.5 mg-200 mg | Oral | 200 | 4 | Stalevo 50/12.5/200mg | |||||||
| Tablet 100 mg-25 mg-200 mg | Oral | 200 | 4 | Stalevo 100/25/200mg | |||||||
| Tablet 150 mg-37.5 mg-200 mg | Oral | 200 | 4 | Stalevo 150/37.5/200mg | |||||||
| Tablet 200 mg-50 mg-200 mg | Oral | 200 | 4 | Stalevo 200/50/200mg | |||||||
Levonorgestrel | Tablets 30 micrograms, 28 | Oral | 4 | 2 | Microlut 28 | |||||||
| Intrauterine drug delivery system 52 mg | Intrauterine | 1 | .. | Mirena | |||||||
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets | Oral | 4 | 2 | Microgynon 50 ED | |||||||
| Tablets 150 micrograms-30 micrograms, 21 | Oral | 4 | 2 | Microgynon 30 | |||||||
| Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Oral | 4 | 2 | Levlen ED | |||||||
|
|
|
|
| Microgynon 30 ED | |||||||
|
|
|
|
| Monofeme 28 | |||||||
|
|
|
|
| Nordette 28 | |||||||
| Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets | Oral | 4 | 2 | Logynon ED | |||||||
|
|
|
|
| Trifeme 28 | |||||||
|
|
|
|
| Triphasil 28 | |||||||
|
|
|
|
| Triquilar ED | |||||||
Lignocaine | Injection containing lignocaine hydrochloride 100 mg in 5 mL | Injection | 5 | .. | Pfizer Australia Pty Ltd | |||||||
| Infusion containing lignocaine hydrochloride 500 mg in 5 mL | Injection | 10 | .. | Xylocard 500 | |||||||
Lincomycin | Injection 600 mg (as hydrochloride) in 2 mL | Injection | 5 | .. | Lincocin | |||||||
Liothyronine | Tablet containing liothyronine sodium 20 micrograms | Oral | 100 | 2 | Tertroxin | |||||||
Lisinopril | Tablet 5 mg | Oral | 30 | 5 | APO-Lisinopril | |||||||
|
|
|
|
| Chem mart Lisinopril | |||||||
|
|
|
|
| Fibsol 5 | |||||||
|
|
|
|
| GenRx Lisinopril | |||||||
|
|
|
|
| Liprace | |||||||
|
|
|
|
| Lisinobell | |||||||
|
|
|
|
| Lisinopril 5 | |||||||
|
|
|
|
| Lisinopril-GA | |||||||
|
|
|
|
| Lisinopril generichealth | |||||||
|
|
|
|
| Lisinopril Hexal Lisinopril Ranbaxy | |||||||
|
|
|
|
| Lisinopril Winthrop | |||||||
|
|
|
|
| Lisodur | |||||||
|
|
|
|
| Prinivil 5 | |||||||
|
|
|
|
| Terry White Chemists Lisinopril | |||||||
|
|
|
|
| Zestril | |||||||
| Tablet 10 mg | Oral | 30 | 5 | APO-Lisinopril | |||||||
|
|
|
|
| Chem mart Lisinopril | |||||||
|
|
|
|
| Fibsol 10 | |||||||
|
|
|
|
| GenRx Lisinopril | |||||||
|
|
|
|
| Liprace | |||||||
|
|
|
|
| Lisinobell | |||||||
|
|
|
|
| Lisinopril 10 | |||||||
|
|
|
|
| Lisinopril generichealth | |||||||
|
|
|
|
| Lisinopril Hexal Lisinopril Ranbaxy | |||||||
|
|
|
|
| Lisinopril Winthrop | |||||||
|
|
|
|
| Lisodur | |||||||
|
|
|
|
| Prinivil 10 | |||||||
|
|
|
|
| Terry White Chemists Lisinopril | |||||||
|
|
|
|
| Zestril | |||||||
| Tablet 20 mg | Oral | 30 | 5 | APO-Lisinopril | |||||||
|
|
|
|
| Chem mart Lisinopril | |||||||
|
|
|
|
| Fibsol 20 | |||||||
|
|
|
|
| GenRx Lisinopril | |||||||
|
|
|
|
| Liprace | |||||||
|
|
|
|
| Lisinobell | |||||||
|
|
|
|
| Lisinopril 20 | |||||||
|
|
|
|
| Lisinopril-GA | |||||||
|
|
|
|
| Lisinopril generichealth | |||||||
|
|
|
|
| Lisinopril Hexal Lisinopril Ranbaxy Lisinopril Sandoz | |||||||
|
|
|
|
| Lisinopril Winthrop | |||||||
|
|
|
|
| Lisodur | |||||||
|
|
|
|
| Prinivil 20 | |||||||
|
|
|
|
| Terry White Chemists Lisinopril | |||||||
|
|
|
|
| Zestril | |||||||
Lithium | Tablet containing lithium carbonate 250 mg | Oral | 200 | 2 | Lithicarb | |||||||
| Tablet containing lithium carbonate 450 mg (slow release) | Oral | 200 | 2 | Quilonum SR | |||||||
Loperamide | Capsule containing loperamide hydrochloride 2 mg | Oral | 12 | .. | Gastro-Stop Loperamide Imodium | |||||||
Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 | Oral | 1 | 5 | Movicol-Half | |||||||
| Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | 1 | 5 | Movicol | |||||||
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 500 mg | Oral | 30 | 2 | Provera | |||||||
| Tablet containing medroxyprogesterone acetate 100 mg | Oral | 100 | 2 | Provera | |||||||
| Tablet containing medroxyprogesterone acetate 200 mg | Oral | 60 | 2 | Provera | |||||||
| Tablet containing medroxyprogesterone acetate 250 mg | Oral | 60 | 2 | Provera | |||||||
| Tablet containing medroxyprogesterone acetate 5 mg | Oral | 56 | 2 | Provera Ralovera | |||||||
| Tablet containing medroxyprogesterone acetate 10 mg | Oral | 30 | 2 | Medroxyhexal Provera Ralovera | |||||||
| Injection containing medroxyprogesterone acetate 50 mg in 1 mL | Injection | 1 | 1 | Depo-Provera | |||||||
| Injection containing medroxyprogesterone acetate 150 mg in 1 mL | Injection | 1 | 1 | Depo-Provera Depo-Ralovera | |||||||
Mefenamic Acid | Capsule 250 mg | Oral | 50 | 2 | Ponstan | |||||||
Megestrol | Tablet containing megestrol acetate 160 mg | Oral | 30 | 2 | Megace | |||||||
Meloxicam | Tablet 7.5 mg | Oral | 30 | 3 | Chem mart Meloxicam 7.5 mg | |||||||
|
|
|
|
| GenRx Meloxicam | |||||||
|
|
|
|
| Meloxibell | |||||||
|
|
|
|
| Meloxicam-GA | |||||||
|
|
|
|
| Meloxicam Ranbaxy | |||||||
|
|
|
|
| Meloxicam Sandoz | |||||||
|
|
|
|
| Meloxicam Winthrop | |||||||
|
|
|
|
| Mobic | |||||||
|
|
|
|
| Movalis 7.5 | |||||||
|
|
|
|
| Moxicam 7.5 | |||||||
|
|
|
|
| Pharmacor Meloxicam 7.5 | |||||||
|
|
|
|
| Terry White Chemists Meloxicam 7.5 mg | |||||||
| Tablet 15 mg | Oral | 30 | 3 | Chem mart Meloxicam 15 mg | |||||||
|
|
|
|
| GenRx Meloxicam | |||||||
|
|
|
|
| Meloxibell | |||||||
|
|
|
|
| Meloxicam-GA | |||||||
|
|
|
|
| Meloxicam Ranbaxy | |||||||
|
|
|
|
| Meloxicam Sandoz | |||||||
|
|
|
|
| Meloxicam Winthrop | |||||||
|
|
|
|
| Mobic | |||||||
|
|
|
|
| Movalis 15 | |||||||
|
|
|
|
| Moxicam 15 | |||||||
|
|
|
|
| Pharmacor Meloxicam 15 | |||||||
|
|
|
|
| Terry White Chemists Meloxicam 15 mg | |||||||
| Capsule 7.5 mg | Oral | 30 | 3 | Mobic | |||||||
|
|
|
|
| Movalis 7.5 | |||||||
| Capsule 15 mg | Oral | 30 | 3 | Mobic | |||||||
|
|
|
|
| Movalis 15 | |||||||
Melphalan | Tablet 2 mg | Oral | 25 | 1 | Alkeran | |||||||
Memantine | Tablet containing memantine hydrochloride 10 mg | Oral | 56 | 5 | Ebixa | |||||||
| Tablet containing memantine hydrochloride 20 mg | Oral | 28 | 5 | Ebixa | |||||||
| Oral drops containing memantine hydrochloride 10 mg per g, 50 g | Oral | 1 | 5 | Ebixa | |||||||
Mercaptopurine | Tablet 50 mg | Oral | 100 | 2 | Purinethol | |||||||
Mesalazine | Tablet 250 mg (enteric coated) | Oral | 100 | 5 | Mesasal | |||||||
| Tablet 500 mg (enteric coated) | Oral | 200 | 5 | Salofalk | |||||||
| Tablet 500 mg (prolonged release) | Oral | 200 | 5 | Pentasa | |||||||
| Sachet containing prolonged release granules, 1 g per sachet | Oral | 100 | 5 | Pentasa | |||||||
| Sachet containing prolonged release granules, 2 g per sachet | Oral | 60 | 5 | Pentasa | |||||||
| Sachet containing granules, 500 mg per sachet | Oral | 200 | 5 | Salofalk | |||||||
| Sachet containing granules, 1 g per sachet | Oral | 100 | 5 | Salofalk | |||||||
| Sachet containing granules, 1.5 g per sachet | Oral | 60 | 5 | Salofalk | |||||||
| Suppositories 1 g, 28 | Rectal | 1 | 1 | Pentasa | |||||||
| Enemas 1 g in 100 mL, 7 | Rectal | 4 | 1 | Pentasa | |||||||
| Enemas 2 g in 60 mL, 7 | Rectal | 4 | 1 | Salofalk | |||||||
| Enemas 4 g in 60 mL, 7 | Rectal | 4 | 1 | Salofalk | |||||||
| Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g | Rectal | 4 | 1 | Salofalk | |||||||
Mesna | Solution for I.V. injection 400 mg in 4 mL ampoule | Injection | 15 | 5 | Uromitexan | |||||||
| Solution for I.V. injection 1 g in 10 mL ampoule | Injection | 15 | 5 | Uromitexan | |||||||
Metformin | Tablet containing metformin hydrochloride 500 mg | Oral | 100 | 5 | Chem mart Metformin | |||||||
|
|
|
|
| Diabex | |||||||
|
|
|
|
| Diaformin | |||||||
|
|
|
|
| Formet 500 | |||||||
|
|
|
|
| Genepharm (Australia) Limited | |||||||
|
|
|
|
| GenRx Metformin | |||||||
|
|
|
|
| Glucohexal | |||||||
|
|
|
|
| Glucophage | |||||||
|
|
|
|
| Metforbell | |||||||
|
|
|
|
| Metformin 500 | |||||||
|
|
|
|
| Metformin-GA | |||||||
|
|
|
|
| Metformin generichealth | |||||||
|
|
|
|
| Metformin Ranbaxy | |||||||
|
|
|
|
| Terry White Chemists Metformin | |||||||
| Tablet (extended release) containing metformin hydrochloride 500 mg | Oral | 90 | 5 | Diabex XR Diaformin XR Metex XR | |||||||
| Tablets (extended release) containing metformin hydrochloride 500 mg, 120 | Oral | 1 | 5 | Diabex XR Diaformin XR Metex XR | |||||||
| Tablet containing metformin hydrochloride 850 mg | Oral | 60 | 5 | Chem mart Metformin | |||||||
|
|
|
|
| Diabex 850 | |||||||
|
|
|
|
| Diaformin 850 | |||||||
|
|
|
|
| Formet 850 | |||||||
|
|
|
|
| Genepharm (Australia) Limited | |||||||
|
|
|
|
| GenRx Metformin | |||||||
|
|
|
|
| Glucohexal | |||||||
|
|
|
|
| Glucophage | |||||||
|
|
|
|
| Metforbell | |||||||
|
|
|
|
| Metformin 850 | |||||||
|
|
|
|
| Metformin generichealth | |||||||
|
|
|
|
| Metformin Ranbaxy | |||||||
|
|
|
|
| Terry White Chemists Metformin | |||||||
| Tablet containing metformin hydrochloride 1 g | Oral | 90 | 5 | Diabex 1000 | |||||||
|
|
|
|
| Diaformin 1000 | |||||||
|
|
|
|
| Formet 1000 | |||||||
|
|
|
|
| Glucohexal | |||||||
|
|
|
|
| Metformin-GA | |||||||
Metformin with Glibenclamide | Tablet containing metformin hydrochloride 250 mg with glibenclamide 1.25 mg | Oral | 90 | 5 | Glucovance 250mg/1.25mg | |||||||
| Tablet containing metformin hydrochloride 500 mg with glibenclamide 2.5 mg | Oral | 90 | 5 | Glucovance 500mg/2.5mg | |||||||
| Tablet containing metformin hydrochloride 500 mg with glibenclamide 5 mg | Oral | 90 | 5 | Glucovance 500mg/5mg | |||||||
Methadone | Tablet containing methadone hydrochloride 10 mg | Oral | 20 | .. | Physeptone | |||||||
| Injection containing methadone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Physeptone | |||||||
Methotrexate | Tablet 2.5 mg | Oral | 30 | 5 | Hospira Pty Limited Methoblastin | |||||||
| Tablet 10 mg | Oral | 15 | 1 | Methoblastin | |||||||
| Injection 5 mg in 2 mL vial | Injection | 5 | .. | Hospira Pty Limited | |||||||
| Injection 50 mg in 2 mL vial | Injection | 5 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
| Solution concentrate for I.V. infusion 500 mg in 20 mL vial | Injection | 1 | .. | Hospira Pty Limited | |||||||
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Injection | 1 | .. | Hospira Pty Limited Methotrexate Ebewe | |||||||
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial | Injection | 1 | .. | Methotrexate Ebewe | |||||||
Methyldopa | Tablet 250 mg | Oral | 100 | 5 | Aldomet Hydopa | |||||||
Methylphenidate | Tablet containing methylphenidate hydrochloride 10 mg | Oral | 100 | 5 | Ritalin 10 | |||||||
| Tablet containing methylphenidate hydrochloride 18 mg (extended release) | Oral | 30 | 5 | Concerta | |||||||
| Tablet containing methylphenidate hydrochloride 27 mg (extended release) | Oral | 30 | 5 | Concerta | |||||||
| Tablet containing methylphenidate hydrochloride 36 mg (extended release) | Oral | 30 | 5 | Concerta | |||||||
| Tablet containing methylphenidate hydrochloride 54 mg (extended release) | Oral | 30 | 5 | Concerta | |||||||
| Capsule containing methylphenidate hydrochloride 20 mg (modified release) | Oral | 30 | 5 | Ritalin LA | |||||||
| Capsule containing methylphenidate hydrochloride 30 mg (modified release) | Oral | 30 | 5 | Ritalin LA | |||||||
| Capsule containing methylphenidate hydrochloride 40 mg (modified release) | Oral | 30 | 5 | Ritalin LA | |||||||
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Injection | 5 | .. | Depo-Medrol Depo-Nisolone | |||||||
| Powder for injection 40 mg (as sodium succinate) with diluent | Injection | 5 | .. | Solu-Medrol | |||||||
| Powder for injection 1 g (as sodium succinate) with diluent | Injection | 1 | .. | Solu-Medrol | |||||||
| Cream containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan | |||||||
| Ointment containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan | |||||||
| Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan | |||||||
| Lotion containing methylprednisolone aceponate 1 mg per g, 20 g | Application | 1 | .. | Advantan | |||||||
Methysergide | Tablet 1 mg (as maleate) | Oral | 100 | 2 | Deseril | |||||||
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Oral | 25 | .. | Maxolon Pramin | |||||||
| Injection containing metoclopramide hydrochloride 10 mg in 2 mL | Injection | 10 | .. | Maxolon | |||||||
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Oral | 100 | 5 | Betaloc | |||||||
|
|
|
|
| Chem mart Metoprolol | |||||||
|
|
|
|
| GenRx Metoprolol | |||||||
|
|
|
|
| Lopresor 50 | |||||||
|
|
|
|
| Metohexal | |||||||
|
|
|
|
| Metrol 50 | |||||||
|
|
|
|
| Minax 50 | |||||||
|
|
|
|
| Terry White Chemists Metoprolol | |||||||
| Tablet containing metoprolol tartrate 100 mg | Oral | 60 | 5 | Betaloc | |||||||
|
|
|
|
| Chem mart Metoprolol | |||||||
|
|
|
|
| GenRx Metoprolol | |||||||
|
|
|
|
| Lopresor 100 | |||||||
|
|
|
|
| Metohexal | |||||||
|
|
|
|
| Metrol 100 | |||||||
|
|
|
|
| Minax 100 | |||||||
|
|
|
|
| Terry White Chemists Metoprolol | |||||||
Metoprolol succinate | Tablet 23.75 mg (controlled release) | Oral | 15 | .. | Toprol-XL 23.75 | |||||||
| Tablet 47.5 mg (controlled release) | Oral | 30 | 5 | Toprol-XL 47.5 | |||||||
| Tablet 95 mg (controlled release) | Oral | 30 | 5 | Toprol-XL 95 | |||||||
| Tablet 190 mg (controlled release) | Oral | 30 | 5 | Toprol-XL 190 | |||||||
Metronidazole | Tablet 200 mg | Oral | 21 | 1 | Flagyl Metrogyl 200 Metronide 200 | |||||||
| Tablet 400 mg | Oral | 5 | 2 | Metrogyl 400 | |||||||
| Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL | Oral | 1 | .. | Flagyl S | |||||||
| I.V. infusion 500 mg in 100 mL | Injection | 5 | 1 | Baxter Healthcare Pty Ltd DBL Metronidazole Intravenous Infusion Metronidazole Sandoz | |||||||
| Suppositories 500 mg, 10 | Rectal | 1 | .. | Flagyl | |||||||
Mexiletine | Capsule containing mexiletine hydrochloride 50 mg | Oral | 100 | 5 | Mexitil | |||||||
| Capsule containing mexiletine hydrochloride 200 mg | Oral | 100 | 5 | Mexitil | |||||||
Mianserin | Tablet containing mianserin hydrochloride 10 mg | Oral | 50 | 5 | Lumin 10 Tolvon | |||||||
| Tablet containing mianserin hydrochloride 20 mg | Oral | 50 | 5 | Lumin 20 Tolvon | |||||||
Miconazole | Cream containing miconazole nitrate 20 mg per g, 15 g | Application | 2 | 3 | Daktarin | |||||||
| Cream containing miconazole nitrate 20 mg per g, 30 g | Application | 1 | 2 | Daktarin | |||||||
| Cream containing miconazole nitrate 20 mg per g, 70 g | Application | 1 | 1 | Daktarin | |||||||
| Powder containing miconazole nitrate 20 mg per g, 30 g | Application | 1 | 2 | Daktarin | |||||||
| Tincture 20 mg per mL, 30 mL | Application | 1 | 2 | Daktarin | |||||||
| Lotion containing miconazole nitrate 20 mg per mL, 30 g | Application | 1 | 2 | Daktarin | |||||||
Milk powder — lactose free formula | Oral powder 900 g (S-26 LF) | Oral | 5 | .. | S-26 LF | |||||||
| Oral powder 900 g (Karicare De-Lact) | Oral | 5 | .. | Karicare De-Lact | |||||||
Milk powder — lactose modified | Oral powder 900 g (Digestelact) | Oral | 3 | 1 | Digestelact | |||||||
Milk powder — synthetic | Low calcium oral powder 400 g (Locasol) | Oral | 8 | 5 | Locasol | |||||||
Milk protein and fat formula with vitamins and minerals — carbohydrate free | Oral powder 225 g (Carbohydrate Free Mixture) | Oral | 24 | 5 | Carbohydrate Free Mixture | |||||||
Mineral mixture | Oral powder 250 g (Metabolic Mineral Mixture) | Oral | 1 | 5 | Metabolic Mineral Mixture | |||||||
Minocycline | Tablet 50 mg (as hydrochloride) | Oral | 60 | 5 | Akamin 50 Minomycin-50 | |||||||
| Capsule 100 mg (as hydrochloride) | Oral | 11 | .. | Akamin 100 | |||||||
Minoxidil | Tablet 10 mg | Oral | 100 | 5 | Loniten | |||||||
Mirtazapine | Tablet 15 mg | Oral | 30 | 5 | Axit 15 | |||||||
| Tablet 15 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab | |||||||
| Tablet 30 mg | Oral | 30 | 5 | Avanza | |||||||
|
|
|
|
| Axit 30 | |||||||
|
|
|
|
| Chem mart Mirtazapine | |||||||
|
|
|
|
| GenRx Mirtazapine | |||||||
|
|
|
|
| Mirtazapine-DP | |||||||
|
|
|
|
| Mirtazapine Sandoz | |||||||
|
|
|
|
| Mirtazon | |||||||
|
|
|
|
| Terry White Chemists Mirtazapine | |||||||
| Tablet 30 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab | |||||||
| Tablet 45 mg | Oral | 30 | 5 | APO-Mirtazapine Avanza Chem mart Mirtazapine Mirtazapine Sandoz Mirtazon Terry White Chemists Mirtazapine | |||||||
| Tablet 45 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab | |||||||
Misoprostol | Tablet 200 micrograms | Oral | 120 | 2 | Cytotec | |||||||
Mitozantrone | Injection 10 mg (as hydrochloride) in 5 mL | Injection | 1 | .. | Pfizer Australia Pty Ltd | |||||||
| Injection 20 mg (as hydrochloride) in 10 mL | Injection | 1 | .. | Hospira Pty Limited | |||||||
|
|
|
|
| Mitozantrone Ebewe | |||||||
|
|
|
|
| Onkotrone | |||||||
|
|
|
|
| Pfizer Australia Pty Ltd | |||||||
| Injection 25 mg (as hydrochloride) in 12.5 mL | Injection | 1 | .. | Onkotrone Pfizer Australia Pty Ltd | |||||||
Moclobemide | Tablet 150 mg | Oral | 60 | 5 | Amira 150 | |||||||
|
|
|
|
| Aurorix | |||||||
|
|
|
|
| Chem mart Moclobemide | |||||||
|
|
|
|
| Clobemix | |||||||
|
|
|
|
| GenRx Moclobemide | |||||||
|
|
|
|
| Mohexal | |||||||
|
|
|
|
| Terry White Chemists Moclobemide | |||||||
| Tablet 300 mg | Oral | 60 | 5 | Amira 300 | |||||||
|
|
|
|
| Aurorix 300 mg | |||||||
|
|
|
|
| Chem mart Moclobemide | |||||||
|
|
|
|
| Clobemix | |||||||
|
|
|
|
| GenRx Moclobemide | |||||||
|
|
|
|
| Maosig | |||||||
|
|
|
|
| Mohexal | |||||||
|
|
|
|
| Terry White Chemists Moclobemide | |||||||
Modafinil | Tablet 100 mg | Oral | 120 | 5 | Modavigil | |||||||
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g | Application | 1 | .. | Elocon Novasone | |||||||
| Ointment containing mometasone furoate 1 mg per g, 15 g | Application | 1 | .. | Elocon Novasone | |||||||
| Lotion containing mometasone furoate 1 mg per g, 30 mL | Application | 1 | .. | Elocon Novasone | |||||||
Montelukast | Tablet, chewable, 4 mg (as sodium) | Oral | 28 | 5 | Singulair | |||||||
| Tablet, chewable, 5 mg (as sodium) | Oral | 28 | 5 | Singulair | |||||||
Morphine | Tablet containing morphine sulfate 10 mg | Oral | 20 | .. | Sevredol | |||||||
| Tablet containing morphine sulfate 20 mg | Oral | 20 | .. | Sevredol | |||||||
| Tablet containing morphine sulfate 30 mg | Oral | 20 | .. | Anamorph | |||||||
| Tablet containing morphine sulfate 5 mg (controlled release) | Oral | 20 | .. | MS Contin | |||||||
| Tablet containing morphine sulfate 10 mg (controlled release) | Oral | 20 | .. | Momex SR 10 MS Contin | |||||||
| Tablet containing morphine sulfate 15 mg (controlled release) | Oral | 20 | .. | MS Contin | |||||||
| Tablet containing morphine sulfate 30 mg (controlled release) | Oral | 20 | .. | Momex SR 30 MS Contin | |||||||
| Tablet containing morphine sulfate 60 mg (controlled release) | Oral | 20 | .. | Momex SR 60 MS Contin | |||||||
| Tablet containing morphine sulfate 100 mg (controlled release) | Oral | 20 | .. | Momex SR 100 MS Contin | |||||||
| Tablet containing morphine sulfate 200 mg (controlled release) | Oral | 20 | .. | MS Contin | |||||||
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | |||||||
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | |||||||
| Capsule containing morphine sulfate 30 mg (controlled release) | Oral | 10 | .. | MS Mono | |||||||
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | |||||||
| Capsule containing morphine sulfate 60 mg (controlled release) | Oral | 10 | .. | MS Mono | |||||||
| Capsule containing morphine sulfate 90 mg (controlled release) | Oral | 10 | .. | MS Mono | |||||||
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | |||||||
| Capsule containing morphine sulfate 120 mg (controlled release) | Oral | 10 | .. | MS Mono | |||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Oral | 20 | .. | MS Contin Suspension 20 mg | |||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Oral | 20 | .. | MS Contin Suspension 30 mg | |||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Oral | 20 | .. | MS Contin Suspension 60 mg | |||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Oral | 20 | .. | MS Contin Suspension 100 mg | |||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet | Oral | 20 | .. | MS Contin Suspension 200 mg | |||||||
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral | 1 | .. | Ordine 2 | |||||||
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral | 1 | .. | Ordine 5 | |||||||
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral | 1 | .. | Ordine 10 | |||||||
| Injection containing morphine sulfate 10 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
| Injection containing morphine tartrate 120 mg in 1.5 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
| Injection containing morphine sulfate 15 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
| Injection containing morphine sulfate 30 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
Moxonidine | Tablet 200 micrograms | Oral | 30 | 5 | Physiotens | |||||||
| Tablet 400 micrograms | Oral | 30 | 5 | Physiotens | |||||||
Mupirocin | Nasal ointment 20 mg (as calcium) per g, 3 g | Nasal | 1 | . . | Bactroban | |||||||
Mycophenolic Acid | Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid | Oral | 120 | 3 | Myfortic | |||||||
| Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid | Oral | 120 | 3 | Myfortic | |||||||
| Capsule containing mycophenolate mofetil 250 mg | Oral | 300 | 3 | CellCept | |||||||
| Tablet containing mycophenolate mofetil 500 mg | Oral | 150 | 3 | CellCept | |||||||
| Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL | Oral | 1 | 3 | CellCept | |||||||
Nafarelin | Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses | Nasal | 1 | 5 | Synarel | |||||||
Naloxone | Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set | Injection | 1 | .. | Naloxone Min-I-Jet | |||||||
Naltrexone | Tablet containing naltrexone hydrochloride 50 mg | Oral | 30 | 1 | Naltrexone generichealth Naltrexone QP ReVia | |||||||
Nandrolone Decanoate | Injection 50 mg in 1 mL disposable syringe | Injection | 1 | 7 | Deca-Durabolin | |||||||
Naproxen | Tablet 250 mg | Oral | 100 | 3 | Inza 250 Naprosyn | |||||||
| Tablet containing naproxen sodium 550 mg | Oral | 50 | 3 | Anaprox 550 Crysanal | |||||||
| Tablet 500 mg | Oral | 50 | 3 | Inza 500 Naprosyn | |||||||
| Tablet 750 mg (sustained release) | Oral | 28 | 3 | Naprosyn SR750 Proxen SR 750 | |||||||
| Tablet 1 g (sustained release) | Oral | 28 | 3 | Naprosyn SR1000 Proxen SR 1000 | |||||||
| Oral suspension 125 mg per 5 mL, 474 mL | Oral | 1 | 3 | Naprosyn | |||||||
Naratriptan | Tablet 2.5 mg (as hydrochloride) | Oral | 4 | 5 | Naramig | |||||||
Nebivolol | Tablet 1.25 mg (as hydrochloride), 28 | Oral | 1 | 5 | Nebilet | |||||||
| Tablet 1.25 mg (as hydrochloride) | Oral | 56 | 5 | Nebilet | |||||||
| Tablet 5 mg (as hydrochloride) | Oral | 28 | 5 | Nebilet | |||||||
| Tablet 10 mg (as hydrochloride) | Oral | 28 | 5 | Nebilet | |||||||
Nedocromil | Pressurised inhalation containing nedocromil sodium 2 mg per dose, 112 doses (CFC-free formulation) | Inhalation by mouth | 1 | 5 | Tilade CFC-Free | |||||||
Neomycin | Tablet containing neomycin sulfate 500 mg | Oral | 25 | 1 | Neosulf | |||||||
Neomycin with Bacitracin | Ear ointment 3.5 mg neomycin (as undecenoate) with bacitracin zinc 400 units per g, 10 g | Application to the ear | 1 | .. | Nemdyn | |||||||
Nicorandil | Tablets 10 mg, 60 | Oral | 1 | 5 | Ikorel | |||||||
| Tablets 20 mg, 60 | Oral | 1 | 5 | Ikorel | |||||||
Nicotine | Transdermal patch 24.9 mg | Transdermal | 28 | 2 | Nicorette Patch | |||||||
Nifedipine | Tablet 10 mg | Oral | 60 | 5 | Adalat 10 Adefin 10 | |||||||
| Tablet 20 mg | Oral | 60 | 5 | Adalat 20 | |||||||
|
|
|
|
| Adefin 20 | |||||||
|
|
|
|
| GenRx Nifedipine | |||||||
|
|
|
|
| Nifehexal | |||||||
| Tablet 20 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 20mg | |||||||
| Tablet 30 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 30 Addos XR 30 Adefin XL 30 APO-Nifedipine XR | |||||||
| Tablet 60 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 60 Addos XR 60 Adefin XL 60 APO-Nifedipine XR | |||||||
Nilotinib | Capsule 200 mg (as hydrochloride monohydrate) | Oral | 112 | 2 | Tasigna | |||||||
Nilutamide | Tablet 150 mg | Oral | 30 | 5 | Anandron | |||||||
Nitrazepam | Tablet 5 mg | Oral | 25 | .. | Alodorm Mogadon | |||||||
Nitrofurantoin | Capsule 50 mg | Oral | 30 | 1 | Macrodantin | |||||||
| Capsule 100 mg | Oral | 30 | 1 | Macrodantin | |||||||
Nizatidine | Capsule 150 mg | Oral | 60 | 5 | Nizac Tacidine Tazac | |||||||
| Capsule 300 mg | Oral | 30 | 5 | Nizac Tacidine Tazac | |||||||
Norethisterone | Tablets 350 micrograms, 28 | Oral | 4 | 2 | Locilan 28 Day Micronor Noriday 28 Day | |||||||
| Tablet 5 mg | Oral | 30 | 2 | Primolut N | |||||||
Norethisterone with Ethinyloestradiol | Tablets 500 micrograms-35 micrograms, 21 | Oral | 4 | 2 | Brevinor | |||||||
| Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets | Oral | 4 | 2 | Brevinor Norimin 28 Day | |||||||
| Tablets 1 mg-35 micrograms, 21 | Oral | 4 | 2 | Brevinor-1 | |||||||
| Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets | Oral | 4 | 2 | Brevinor-1 Norimin-1 28 Day | |||||||
| Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets 1 mg-35 micrograms and 7 inert tablets | Oral | 4 | 2 | Improvil 28 Day Synphasic | |||||||
Norethisterone with Mestranol | Tablets 1 mg-50 micrograms, 21 | Oral | 4 | 2 | Norinyl-1 | |||||||
| Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets | Oral | 4 | 2 | Norinyl-1/28 | |||||||
Norfloxacin | Tablet 400 mg | Oral | 14 | 1 | Chem mart Norfloxacin | |||||||
|
|
|
|
| Genepharm Pty Ltd | |||||||
|
|
|
|
| GenRx Norfloxacin | |||||||
|
|
|
|
| Norflohexal | |||||||
|
|
|
|
| Noroxin | |||||||
|
|
|
|
| Nufloxib | |||||||
|
|
|
|
| Roxin | |||||||
|
|
|
|
| Terry White Chemists Norfloxacin | |||||||
Nortriptyline | Tablet 10 mg (as hydrochloride) | Oral | 50 | 2 | Allegron | |||||||
| Tablet 25 mg (as hydrochloride) | Oral | 50 | 2 | Allegron | |||||||
Nystatin | Tablet 500,000 units | Oral | 50 | .. | Nilstat | |||||||
| Capsule 500,000 units | Oral | 50 | .. | Nilstat | |||||||
| Oral suspension 100,000 units per mL, 24 mL | Oral | 1 | 1 | Mycostatin Nilstat | |||||||
| Cream 100,000 units per g, 15 g | Application | 2 | 3 | Mycostatin | |||||||
Oestradiol | Tablet 2 mg | Oral | 56 | 2 | Zumenon | |||||||
| Tablet containing oestradiol valerate 1 mg | Oral | 56 | 2 | Progynova | |||||||
| Tablet containing oestradiol valerate 2 mg | Oral | 56 | 2 | Progynova | |||||||
| Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28 | Transdermal | 1 | 5 | Sandrena | |||||||
| Transdermal patches 390 micrograms, 8 | Transdermal | 1 | 5 | Estradot 25 | |||||||
| Transdermal patches 750 micrograms (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 25 | |||||||
| Transdermal patches 2 mg, 4 | Transdermal | 1 | 5 | Climara 25 | |||||||
| Transdermal patches 2 mg, 8 | Transdermal | 1 | 5 | Estraderm 25 | |||||||
| Transdermal patches 585 micrograms, 8 | Transdermal | 1 | 5 | Estradot 37.5 | |||||||
| Transdermal patches 1.5 mg (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 50 | |||||||
| Transdermal patches 3.8 mg, 4 | Transdermal | 1 | 5 | Climara 50 | |||||||
| Transdermal patches 4 mg, 8 | Transdermal | 1 | 5 | Estraderm 50 | |||||||
| Transdermal patches 780 micrograms, 8 | Transdermal | 1 | 5 | Estradot 50 | |||||||
| Transdermal patches 5.7 mg, 4 | Transdermal | 1 | 5 | Climara 75 | |||||||
| Transdermal patches 1.17 mg, 8 | Transdermal | 1 | 5 | Estradot 75 | |||||||
| Transdermal patches 3 mg (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 100 | |||||||
| Transdermal patches 7.6 mg, 4 | Transdermal | 1 | 5 | Climara 100 | |||||||
| Transdermal patches 8 mg, 8 | Transdermal | 1 | 5 | Estraderm 100 | |||||||
| Transdermal patches 1.56 mg, 8 | Transdermal | 1 | 5 | Estradot 100 | |||||||
| Vaginal tablets 25 micrograms, 15 | Vaginal | 1 | 2 | Vagifem | |||||||
Oestradiol and Oestradiol with Dydrogesterone | Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg | Oral | 1 | 5 | Femoston 2/10 | |||||||
Oestradiol and Oestradiol with Norethisterone | Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate | Transdermal | 1 | 5 | Estalis sequi 50/140 | |||||||
| Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate | Transdermal | 1 | 5 | Estalis sequi 50/250 | |||||||
| Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg | Transdermal | 1 | 5 | Estracombi | |||||||
Oestradiol with Norethisterone | Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 | Transdermal | 1 | 5 | Estalis continuous 50/140 | |||||||
| Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 | Transdermal | 1 | 5 | Estalis continuous 50/250 | |||||||
Oestriol | Pessaries 500 micrograms, 15 | Vaginal | 1 | 2 | Ovestin Ovula | |||||||
| Vaginal cream 1 mg per g, 15 g | Application | 1 | 1 | Ovestin | |||||||
Ofloxacin | Eye drops 3 mg per mL, 5 mL | Application to the eye | 2 | .. | Ocuflox | |||||||
Olanzapine | Tablet 2.5 mg | Oral | 28 | 5 | Zyprexa | |||||||
| Tablet 5 mg | Oral | 28 | 5 | Zyprexa | |||||||
| Tablet 7.5 mg | Oral | 28 | 5 | Zyprexa | |||||||
| Tablet 10 mg | Oral | 28 | 5 | Zyprexa | |||||||
| Wafer 5 mg | Oral | 28 | 5 | Zyprexa Zydis | |||||||
| Wafer 10 mg | Oral | 28 | 5 | Zyprexa Zydis | |||||||
| Powder for injection 210 mg (as pamoate monohydrate) with diluent | Injection | 2 | 5 | Zyprexa Relprevv | |||||||
| Powder for injection 300 mg (as pamoate monohydrate) with diluent | Injection | 2 | 5 | Zyprexa Relprevv | |||||||
| Powder for injection 405 mg (as pamoate monohydrate) with diluent | Injection | 1 | 5 | Zyprexa Relprevv | |||||||
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Oral | 30 | 5 | Olmetec | |||||||
| Tablet containing olmesartan medoxomil 40 mg | Oral | 30 | 5 | Olmetec | |||||||
Olmesartan with Hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Olmetec Plus | |||||||
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Olmetec Plus | |||||||
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Oral | 30 | 5 | Olmetec Plus | |||||||
Olsalazine | Capsule containing olsalazine sodium 250 mg | Oral | 100 | 5 | Dipentum | |||||||
| Tablet containing olsalazine sodium 500 mg | Oral | 100 | 5 | Dipentum | |||||||
Omeprazole | Tablet 20 mg (as magnesium) | Oral | 30 | 1 | Acimax Tablets Losec Tablets Omepral | |||||||
| Tablet 20 mg | Oral | 30 | 1 | APO-Omeprazole | |||||||
|
|
|
|
| Chem mart Omeprazole | |||||||
|
|
|
|
| GenRx Omeprazole | |||||||
|
|
|
|
| Meprazol | |||||||
|
|
|
|
| Omeprazole-GA | |||||||
|
|
|
|
| Omeprazole Ranbaxy | |||||||
|
|
|
|
| Omeprazole Winthrop | |||||||
|
|
|
|
| Ozmep | |||||||
|
|
|
|
| Terry White Chemists Omeprazole | |||||||
| Capsule 20 mg | Oral | 30 | 1 | Probitor | |||||||
| Tablet 10 mg (as magnesium) | Oral | 30 | 5 | Losec Tablets | |||||||
Omeprazole and Clarithromycin and Amoxycillin | Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | 1 | .. | Klacid Hp 7 | |||||||
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Oral | 4 | .. | APO-Ondansetron | |||||||
|
|
|
|
| Ondansetron-RL | |||||||
|
|
|
|
| Ondaz | |||||||
|
|
|
|
| Onsetron 4 | |||||||
|
|
|
|
| Zofran | |||||||
| Tablet 8 mg (as hydrochloride dihydrate) | Oral | 4 | .. | APO-Ondansetron | |||||||
|
|
|
|
| Ondansetron-RL | |||||||
|
|
|
|
| Ondaz | |||||||
|
|
|
|
| Onsetron 8 | |||||||
|
|
|
|
| Zofran | |||||||
| Wafer 4 mg | Oral | 4 | .. | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |||||||
| Wafer 8 mg | Oral | 4 | .. | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |||||||
| Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL | Oral | 1 | . . | Zofran syrup 50 mL | |||||||
| I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL | Injection | 1 | .. | Ondansetron-RL | |||||||
|
|
|
|
| Ondaz | |||||||
|
|
|
|
| Onsetron | |||||||
|
|
|
|
| Pfizer Australia Pty Ltd | |||||||
|
|
|
|
| Zofran | |||||||
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Injection | 1 | .. | Ondansetron-RL | |||||||
|
|
|
|
| Ondaz | |||||||
|
|
|
|
| Onsetron | |||||||
|
|
|
|
| Pfizer Australia Pty Ltd | |||||||
|
|
|
|
| Zofran | |||||||
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL | Injection | 1 | 2 | Eloxatin | |||||||
| Powder for I.V. infusion 50 mg | Injection | 1 | 2 | Hospira Pty Limited | |||||||
|
|
|
|
| Oxalatin | |||||||
|
|
|
|
| Oxaliplatin Actavis | |||||||
|
|
|
|
| Oxaliplatin Alphapharm | |||||||
|
|
|
|
| Oxaliplatin Ebewe | |||||||
| Solution concentrate for I.V. infusion 100 mg in 20 mL | Injection | 1 | 2 | Eloxatin | |||||||
| Powder for I.V. infusion 100 mg | Injection | 1 | 2 | Hospira Pty Limited | |||||||
|
|
|
|
| Oxalatin | |||||||
|
|
|
|
| Oxaliplatin Actavis | |||||||
|
|
|
|
| Oxaliplatin Alphapharm | |||||||
|
|
|
|
| Oxaliplatin Ebewe | |||||||
|
|
|
|
| Oxaliplatin Link | |||||||
|
|
|
|
| Winthrop Oxaliplatin | |||||||
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | 1 | 2 | Eloxatin | |||||||
Oxazepam | Tablet 15 mg | Oral | 25 | .. | Alepam 15 Serepax | |||||||
| Tablet 30 mg | Oral | 25 | .. | Alepam 30 Murelax Serepax | |||||||
Oxcarbazepine | Tablet 150 mg | Oral | 100 | 5 | Trileptal | |||||||
| Tablet 300 mg | Oral | 100 | 5 | Trileptal | |||||||
| Tablet 600 mg | Oral | 100 | 5 | Trileptal | |||||||
| Oral suspension 60 mg per mL, 250 mL | Oral | 2 | 5 | Trileptal | |||||||
Oxprenolol | Tablet containing oxprenolol hydrochloride 20 mg | Oral | 100 | 5 | Corbeton 20 | |||||||
| Tablet containing oxprenolol hydrochloride 40 mg | Oral | 100 | 5 | Corbeton 40 | |||||||
Oxybutynin | Tablet containing oxybutynin hydrochloride 5 mg | Oral | 100 | 5 | Ditropan Oxybutynin Sandoz Oxybutynin Winthrop | |||||||
| Transdermal patches 36 mg, 8 | Transdermal | 1 | 5 | Oxytrol | |||||||
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | Endone | |||||||
| Capsule containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | OxyNorm | |||||||
| Capsule containing oxycodone hydrochloride 10 mg | Oral | 20 | .. | OxyNorm | |||||||
| Capsule containing oxycodone hydrochloride 20 mg | Oral | 20 | .. | OxyNorm | |||||||
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL | Oral | 1 | .. | OxyNorm Liquid 5mg/5mL | |||||||
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) | Oral | 20 | .. | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) | Oral | 20 | .. | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 15 mg (controlled release) | Oral | 20 | . . | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) | Oral | 20 | .. | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 30 mg (controlled release) | Oral | 20 | . . | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) | Oral | 20 | .. | OxyContin | |||||||
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) | Oral | 20 | .. | OxyContin | |||||||
| Suppository 30 mg (as pectinate) | Rectal | 12 | .. | Proladone | |||||||
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | 5 | .. | Anzatax Paclitaxel Actavis Paclitaxel Ebewe Taxol | |||||||
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | 2 | .. | Anzatax Paclitaxel Actavis Paclitaxel Ebewe Taxol | |||||||
| Solution concentrate for I.V. infusion 150 mg in 25 mLl | Injection | 2 | .. | Anzatax Paclitaxel Actavis Paclitaxel Ebewe | |||||||
| Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | 1 | .. | Anzatax Paclitaxel Actavis Paclitaxel Ebewe Taxol | |||||||
Paclitaxel, nanoparticle albumin-bound | Powder for I.V. injection containing 100 mg paclitaxel | Injection | 1 | .. | Abraxane | |||||||
Paliperidone | Tablet 3 mg (prolonged release) | Oral | 28 | 5 | Invega | |||||||
| Tablet 6 mg (prolonged release) | Oral | 28 | 5 | Invega | |||||||
| Tablet 9 mg (prolonged release) | Oral | 28 | 5 | Invega | |||||||
Pamidronic Acid | Concentrated injection containing disodium pamidronate 15 mg in 5 mL | Injection | 4 | .. | Pamisol | |||||||
| Injection set containing 4 vials powder for I.V. infusion containing disodium pamidronate 15 mg and 4 ampoules solvent 5 mL | Injection | 1 | .. | Aredia 15 mg | |||||||
| Concentrated injection containing disodium pamidronate 30 mg in 10 mL | Injection | 2 | .. | Pamisol | |||||||
| Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL | Injection | 1 | .. | Aredia 30 mg | |||||||
| Concentrated injection containing disodium pamidronate 60 mg in 10 mL | Injection | 1 | .. | Pamisol | |||||||
Pancreatic Extract | Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity | Oral | 500 | 10 | Creon 5000 | |||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity | Oral | 500 | 10 | Creon 10,000 | |||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity | Oral | 200 | 10 | Creon 25,000 | |||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity | Oral | 200 | 10 | Creon 40,000 | |||||||
Pancrelipase | Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity | Oral | 200 | 10 | Panzytrat 25000 | |||||||
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | 30 | 2 | Somac | |||||||
| Sachet containing granules 40 mg (as sodium sesquihydrate) | Oral | 30 | 2 | Somac | |||||||
| Tablet (enteric coated) 20 mg (as sodium sesquihydrate) | Oral | 30 | 5 | Somac | |||||||
Paracetamol | Tablet 500 mg | Oral | 100 | 1 | APO-Paracetamol Chem mart Paracetamol | |||||||
|
|
|
|
| Dymadon P | |||||||
|
|
|
|
| Febridol | |||||||
|
|
|
|
| Generic Health Pty Ltd | |||||||
|
|
|
|
| Panamax | |||||||
|
|
|
|
| Paracetamol Sandoz | |||||||
|
|
|
|
| Paralgin | |||||||
|
|
|
|
| Pharmacy Choice Paracetamol | |||||||
|
|
|
|
| Terry White Chemists Paracetamol | |||||||
| Tablet 665 mg (modified release) | Oral | 192 | 5 | Panadol Osteo | |||||||
| Oral liquid 120 mg per 5 mL, 100 mL | Oral | 1 | 2 | Panamax | |||||||
| Oral liquid 240 mg per 5 mL, 200 mL | Oral | 1 | 2 | Panamax 240 Elixir | |||||||
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | 2 | 5 | Duratears Poly Visc | |||||||
| Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | 1 | 5 | Ircal Lacri-Lube Poly Visc | |||||||
Paroxetine | Tablet 20 mg (as hydrochloride) | Oral | 30 | 5 | Aropax | |||||||
|
|
|
|
| Chem mart Paroxetine | |||||||
|
|
|
|
| Extine 20 | |||||||
|
|
|
|
| GenRx Paroxetine | |||||||
|
|
|
|
| Paroxetine 20 | |||||||
|
|
|
|
| Paroxetine-DP | |||||||
|
|
|
|
| Paroxetine-GA | |||||||
|
|
|
|
| Paroxetine Sandoz | |||||||
|
|
|
|
| Paxtine | |||||||
|
|
|
|
| Terry White Chemists Paroxetine | |||||||
| Tablet 20 mg (as mesilate) | Oral | 30 | 5 | Paroxetine generichealth | |||||||
Pemetrexed | Powder for I.V. infusion 100 mg (as disodium heptahydrate) | Injection | 1 | 3 | Alimta | |||||||
| Powder for I.V. infusion 500 mg (as disodium heptahydrate) | Injection | 1 | 3 | Alimta | |||||||
Penicillamine | Tablet 125 mg | Oral | 100 | 1 | D-Penamine | |||||||
| Tablet 250 mg | Oral | 100 | 1 | D-Penamine | |||||||
Pergolide | Tablet 50 micrograms (as mesylate) | Oral | 100 | .. | Permax | |||||||
| Tablet 250 micrograms (as mesylate) | Oral | 100 | 5 | Permax | |||||||
| Tablet 1 mg (as mesylate) | Oral | 100 | 5 | Permax | |||||||
Perhexiline | Tablet containing perhexiline maleate 100 mg | Oral | 100 | 5 | Pexsig | |||||||
Pericyazine | Tablet 2.5 mg | Oral | 100 | 5 | Neulactil | |||||||
| Tablet 10 mg | Oral | 100 | 5 | Neulactil | |||||||
Perindopril | Tablet containing perindopril erbumine 2 mg | Oral | 30 | 5 | Chem mart Perindopril | |||||||
|
|
|
|
| GenRx Perindopril | |||||||
|
|
|
|
| Indopril 2 | |||||||
|
|
|
|
| Ozapace | |||||||
|
|
|
|
| Perindo | |||||||
|
|
|
|
| Perindopril 2 | |||||||
|
|
|
|
| Perindopril-DP | |||||||
|
|
|
|
| Terry White Chemists Perindopril | |||||||
| Tablet containing perindopril arginine 2.5 mg | Oral | 30 | 5 | Coversyl 2.5mg | |||||||
| Tablet containing perindopril erbumine 4 mg | Oral | 30 | 5 | Chem mart Perindopril | |||||||
|
|
|
|
| GenRx Perindopril | |||||||
|
|
|
|
| Indopril 4 | |||||||
|
|
|
|
| Ozapace | |||||||
|
|
|
|
| Perindo | |||||||
|
|
|
|
| Perindopril 4 | |||||||
|
|
|
|
| Perindopril-DP | |||||||
|
|
|
|
| Terry White Chemists Perindopril | |||||||
| Tablet containing perindopril arginine 5 mg | Oral | 30 | 5 | Coversyl 5mg | |||||||
| Tablet containing perindopril erbumine 8 mg | Oral | 30 | 5 | Chem mart Perindopril | |||||||
|
|
|
|
| GenRx Perindopril | |||||||
|
|
|
|
| Indopril 8 | |||||||
|
|
|
|
| Ozapace | |||||||
|
|
|
|
| Perindo | |||||||
|
|
|
|
| Perindopril 8 | |||||||
|
|
|
|
| Perindopril-DP | |||||||
|
|
|
|
| Terry White Chemists Perindopril | |||||||
| Tablet containing perindopril arginine 10 mg | Oral | 30 | 5 | Coversyl 10mg | |||||||
Perindopril with Indapamide | Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg | Oral | 30 | 5 | Coversyl Plus LD 2.5mg/0.625mg | |||||||
| Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Oral | 30 | 5 | Chem mart Perindopril/ Indapamide 4/1.25 | |||||||
|
|
|
|
| GenRx Perindopril/ Indapamide 4/1.25 | |||||||
|
|
|
|
| Perindo Combi 4/1.25 | |||||||
|
|
|
|
| Terry White Chemists Perindopril/ Indapamide 4/1.25 | |||||||
| Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg | Oral | 30 | 5 | Coversyl Plus 5mg/1.25mg | |||||||
Permethrin | Cream 50 mg per g, 30 g | Application | 1 | 1 | Lyclear | |||||||
Phenelzine | Tablet 15 mg (as sulfate) | Oral | 100 | 1 | Nardil | |||||||
Phenobarbitone | Tablet 30 mg | Oral | 200 | 4 | Sigma Pharmaceuticals (Australia) Pty Ltd | |||||||
| Injection containing phenobarbitone sodium 200 mg in 1 mL | Injection | 5 | .. | Fawns and McAllan Proprietary Limited | |||||||
Phenoxybenzamine | Capsule containing phenoxybenzamine hydrochloride 10 mg | Oral | 100 | 5 | Dibenyline | |||||||
| Capsules containing phenoxybenzamine hydrochloride 10 mg, 30 | Oral | 3 | 5 | Dibenyline | |||||||
| Capsules containing phenoxybenzamine hydrochloride 10 mg, 100 | Oral | 1 | 5 | Dibenzyline | |||||||
Phenoxymethylpenicillin | Tablet 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin-VK Filmtab | |||||||
| Tablet 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin-VK Filmtab | |||||||
| Capsule 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK | |||||||
|
|
|
|
| Cilopen VK | |||||||
|
|
|
|
| LPV | |||||||
| Capsule 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK | |||||||
|
|
|
|
| Cilopen VK | |||||||
|
|
|
|
| LPV | |||||||
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | 1 | Abbocillin-V Cilicaine V | |||||||
Phenylalanine with carbohydrate | Sachets of oral powder 4 g containing 50 mg phenylalanine, 30 (Phenylalanine Amino Acid Supplement) | Oral | 4 | 5 | Phenylalanine Amino Acid Supplement | |||||||
Phenytoin | Tablet 50 mg | Oral | 200 | 2 | Dilantin Infatabs | |||||||
| Capsule containing phenytoin sodium 30 mg | Oral | 200 | 2 | Dilantin Sodium | |||||||
| Capsule containing phenytoin sodium 100 mg | Oral | 200 | 2 | Dilantin Sodium | |||||||
| Oral suspension 30 mg per 5 mL, 500 mL | Oral | 1 | 3 | Dilantin | |||||||
Pilocarpine | Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt | |||||||
| Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt | |||||||
| Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt | |||||||
| Eye drops containing pilocarpine hydrochloride 60 mg per mL, 15 mL | Application to the eye | 1 | 5 | P.V. Carpine Pilopt | |||||||
Pimecrolimus | Cream 10 mg per g, 15 g | Application | 1 | 1 | Elidel | |||||||
Pindolol | Tablet 5 mg | Oral | 100 | 5 | Barbloc 5 Visken 5 | |||||||
| Tablet 15 mg | Oral | 50 | 5 | Barbloc 15 Visken 15 | |||||||
Pioglitazone | Tablet 15 mg (as hydrochloride) | Oral | 28 | 5 | Actos | |||||||
| Tablet 30 mg (as hydrochloride) | Oral | 28 | 5 | Actos | |||||||
| Tablet 45 mg (as hydrochloride) | Oral | 28 | 5 | Actos | |||||||
Piroxicam | Dispersible tablet 10 mg | Oral | 50 | 3 | Mobilis D-10 | |||||||
| Dispersible tablet 20 mg | Oral | 25 | 3 | Feldene-D | |||||||
|
|
|
|
| Mobilis D-20 | |||||||
| Capsule 10 mg | Oral | 50 | 3 | Chem mart Piroxicam | |||||||
|
|
|
|
| Feldene | |||||||
|
|
|
|
| GenRx Piroxicam | |||||||
|
|
|
|
| Mobilis 10 | |||||||
|
|
|
|
| Terry White Chemists Piroxicam | |||||||
| Capsule 20 mg | Oral | 25 | 3 | Chem mart Piroxicam | |||||||
|
|
|
|
| Feldene | |||||||
|
|
|
|
| GenRx Piroxicam | |||||||
|
|
|
|
| Mobilis 20 | |||||||
|
|
|
|
| Terry White Chemists Piroxicam | |||||||
Pizotifen | Tablet 500 micrograms (as malate) | Oral | 100 | 2 | Sandomigran 0.5 | |||||||
Pneumococcal Vaccine - Polyvalent | Injection 0.5 mL (23 valent) | Injection | 1 | .. | Pneumovax 23 | |||||||
Polyethylene glycol 400 | Eye drops 2.5 mg per mL, 15 mL | Application to the eye | 1 | 5 | Blink Intensive Tears | |||||||
| Eye drops 2.5 mg per mL, single dose units 0.4 mL, 20 | Application to the eye | 5 | 5 | Blink Intensive Tears | |||||||
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg-3 mg per mL, 15 mL | Application to the eye | 1 | 5 | Systane | |||||||
| Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 | Application to the eye | 2 | 5 | Systane | |||||||
Polygeline | I.V. infusion 17.5 g per 500 mL with electrolytes, 500 mL | Injection | 3 | .. | Haemaccel | |||||||
Poly-l-lactic acid | Powder for injection 150 mg | Injection | 2 | . . | Sculptra | |||||||
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL | Application to the eye | 1 | 5 | Liquifilm Tears PVA Tears | |||||||
| Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | 1 | 5 | Vistil | |||||||
| Eye drops 30 mg per mL, 15 mL | Application to the eye | 1 | 5 | Liquifilm Forte PVA Forte | |||||||
| Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | 1 | 5 | Vistil Forte | |||||||
Posaconazole | Oral suspension 40 mg per mL, 105 mL | Oral | 6 | 2 | Noxafil | |||||||
Potassium Chloride | Tablet 600 mg (sustained release) | Oral | 200 | 1 | Duro-K Slow-K Span-K | |||||||
Potassium Chloride with Potassium Bicarbonate | Tablet, effervescent, 14 mmol potassium and 8 mmol chloride | Oral | 60 | 1 | Chlorvescent K-Sol | |||||||
Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms | Oral | 30 | .. | Sifrol | |||||||
| Tablet containing pramipexole hydrochloride 250 micrograms | Oral | 100 | 2 | Sifrol | |||||||
| Tablet containing pramipexole hydrochloride 1 mg | Oral | 100 | 5 | Sifrol | |||||||
Prasugrel | Tablet 5 mg (as hydrochloride) | Oral | 28 | 5 | Effient | |||||||
| Tablet 10 mg (as hydrochloride) | Oral | 28 | 5 | Effient | |||||||
Pravastatin | Tablet containing pravastatin sodium 10 mg | Oral | 30 | 5 | APO-Pravastatin | |||||||
|
|
|
|
| Chem mart Pravastatin | |||||||
|
|
|
|
| Cholstat 10 | |||||||
|
|
|
|
| GenRx Pravastatin | |||||||
|
|
|
|
| Lipostat 10 | |||||||
|
|
|
|
| Liprachol | |||||||
|
|
|
|
| Pravachol | |||||||
|
|
|
|
| Pravastatin 10 | |||||||
|
|
|
|
| Pravastatin-GA 10 | |||||||
|
|
|
|
| Pravastatin generichealth | |||||||
|
|
|
|
| Pravastatin Winthrop | |||||||
|
|
|
|
| Terry White Chemists Pravastatin | |||||||
| Tablet containing pravastatin sodium 20 mg | Oral | 30 | 5 | APO-Pravastatin Chem mart Pravastatin | |||||||
|
|
|
|
| Cholstat 20 | |||||||
|
|
|
|
| GenRx Pravastatin | |||||||
|
|
|
|
| Lipostat 20 | |||||||
|
|
|
|
| Liprachol | |||||||
|
|
|
|
| Pravachol | |||||||
|
|
|
|
| Pravastatin 20 | |||||||
|
|
|
|
| Pravastatin-GA 20 | |||||||
|
|
|
|
| Pravastatin generichealth | |||||||
|
|
|
|
| Pravastatin Winthrop | |||||||
|
|
|
|
| Terry White Chemists Pravastatin | |||||||
|
|
|
|
| Vastoran | |||||||
| Tablet containing pravastatin sodium 40 mg | Oral | 30 | 5 | APO-Pravastatin Chem mart Pravastatin | |||||||
|
|
|
|
| Cholstat 40 | |||||||
|
|
|
|
| GenRx Pravastatin | |||||||
|
|
|
|
| Lipostat 40 | |||||||
|
|
|
|
| Liprachol | |||||||
|
|
|
|
| Pravachol | |||||||
|
|
|
|
| Pravastatin 40 | |||||||
|
|
|
|
| Pravastatin-GA 40 | |||||||
|
|
|
|
| Pravastatin generichealth | |||||||
|
|
|
|
| Pravastatin Winthrop | |||||||
|
|
|
|
| Terry White Chemists Pravastatin | |||||||
|
|
|
|
| Vastoran | |||||||
| Tablet containing pravastatin sodium 80 mg | Oral | 30 | 5 | APO-Pravastatin | |||||||
|
|
|
|
| Chem mart Pravastatin | |||||||
|
|
|
|
| Lipostat 80 | |||||||
|
|
|
|
| Pravachol | |||||||
|
|
|
|
| Pravastatin-GA 80 | |||||||
|
|
|
|
| Pravastatin generichealth | |||||||
|
|
|
|
| Pravastatin Sandoz | |||||||
|
|
|
|
| Terry White Chemists Pravastatin | |||||||
Praziquantel | Tablet 600 mg | Oral | 8 | . . | Biltricide | |||||||
Prazosin | Tablet 1 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin | |||||||
|
|
|
|
| GenRx Prazosin | |||||||
|
|
|
|
| Minipress | |||||||
|
|
|
|
| Pressin 1 | |||||||
|
|
|
|
| Terry White Chemists Prazosin | |||||||
| Tablet 2 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin | |||||||
|
|
|
|
| GenRx Prazosin | |||||||
|
|
|
|
| Minipress | |||||||
|
|
|
|
| Pressin 2 | |||||||
|
|
|
|
| Terry White Chemists Prazosin | |||||||
| Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin | |||||||
|
|
|
|
| GenRx Prazosin | |||||||
|
|
|
|
| Minipress | |||||||
|
|
|
|
| Pressin 5 | |||||||
|
|
|
|
| Terry White Chemists Prazosin | |||||||
Prednisolone | Tablet 1 mg | Oral | 100 | 4 | Panafcortelone Predsolone | |||||||
| Tablet 5 mg | Oral | 60 | 4 | Panafcortelone Solone | |||||||
| Tablet 25 mg | Oral | 30 | 4 | Panafcortelone Solone | |||||||
| Oral solution 5 mg (as sodium phosphate) per mL, 30 mL | Oral | 1 | 5 | PredMix Redipred | |||||||
| Enema, retention, 20 mg (as sodium phosphate) in 100 mL | Rectal | 28 | 3 | Predsol | |||||||
| Suppositories 5 mg (as sodium phosphate), 10 | Rectal | 3 | 3 | Predsol | |||||||
Prednisolone with Phenylephrine | Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL | Application to the eye | 1 | 2 | Prednefrin Forte | |||||||
Prednisone | Tablet 1 mg | Oral | 100 | 4 | Panafcort Predsone | |||||||
| Tablet 5 mg | Oral | 60 | 4 | Panafcort Sone | |||||||
| Tablet 25 mg | Oral | 30 | 4 | Panafcort Sone | |||||||
Primidone | Tablet 250 mg | Oral | 200 | 2 | Mysoline | |||||||
Probenecid | Tablet 500 mg | Oral | 100 | 5 | Pro-Cid | |||||||
Procaine Penicillin | Injection 1.5 g in disposable syringe | Injection | 5 | .. | Cilicaine | |||||||
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Oral | 25 | .. | Stemetil Stemzine | |||||||
| Injection containing prochlorperazine mesylate 12.5 mg in 1 mL | Injection | 10 | .. | Stemetil | |||||||
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 | Rectal | 1 | 2 | Stemetil | |||||||
Promethazine | Injection containing promethazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Hospira Pty Limited | |||||||
Propantheline | Tablet containing propantheline bromide 15 mg | Oral | 200 | 5 | Pro-Banthine | |||||||
Propranolol | Tablet containing propranolol hydrochloride 10 mg | Oral | 100 | 5 | Deralin 10 Inderal | |||||||
| Tablet containing propranolol hydrochloride 40 mg | Oral | 100 | 5 | Deralin 40 Inderal | |||||||
| Tablet containing propranolol hydrochloride 160 mg | Oral | 50 | 5 | Deralin 160 | |||||||
Propylthiouracil | Tablet 50 mg | Oral | 200 | 2 | PTU | |||||||
Protein hydrolysate formula with medium chain triglycerides | Oral powder 400 g (Alfaré) | Oral | 8 | 5 | Alfaré | |||||||
| Oral powder 450 g (Pepti-Junior Gold) | Oral | 8 | 5 | Pepti-Junior Gold | |||||||
Pyrantel | Tablet 125 mg (as embonate) | Oral | 6 | .. | Anthel 125 | |||||||
| Tablet 250 mg (as embonate) | Oral | 6 | .. | Anthel 250 | |||||||
Pyridostigmine | Tablet containing pyridostigmine bromide 10 mg | Oral | 100 | 5 | Mestinon | |||||||
| Tablet containing pyridostigmine bromide 60 mg | Oral | 150 | 5 | Mestinon | |||||||
| Tablet containing pyridostigmine bromide 180 mg (modified release) | Oral | 100 | 5 | Mestinon Timespan | |||||||
Pyrimethamine | Tablet 25 mg | Oral | 50 | .. | Daraprim | |||||||
Quetiapine | Tablet 25 mg (as fumarate) | Oral | 60 | 5 | Seroquel | |||||||
| Tablet 100 mg (as fumarate) | Oral | 90 | 5 | Seroquel | |||||||
| Tablet 200 mg (as fumarate) | Oral | 60 | 5 | Seroquel | |||||||
| Tablet 300 mg (as fumarate) | Oral | 60 | 5 | Seroquel | |||||||
| Tablet (modified release) 50 mg (as fumarate) | Oral | 60 | 5 | Seroquel XR | |||||||
| Tablet (modified release) 200 mg (as fumarate) | Oral | 60 | 5 | Seroquel XR | |||||||
| Tablet (modified release) 300 mg (as fumarate) | Oral | 60 | 5 | Seroquel XR | |||||||
| Tablet (modified release) 400 mg (as fumarate) | Oral | 60 | 5 | Seroquel XR | |||||||
Quinagolide | Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride) | Oral | 1 | .. | Norprolac | |||||||
| Tablet 75 micrograms (as hydrochloride) | Oral | 30 | 5 | Norprolac | |||||||
Quinapril | Tablet 5 mg (as hydrochloride) | Oral | 30 | 5 | Accupril | |||||||
|
|
|
|
| Acquin 5 | |||||||
|
|
|
|
| APO-Quinapril | |||||||
|
|
|
|
| Filpril | |||||||
|
|
|
|
| Pharmacor Quinapril 5 | |||||||
|
|
|
|
| Quinapril generichealth | |||||||
|
|
|
|
| Quinapril Sandoz | |||||||
| Tablet 10 mg (as hydrochloride) | Oral | 30 | 5 | Accupril | |||||||
|
|
|
|
| Acquin 10 | |||||||
|
|
|
|
| APO-Quinapril | |||||||
|
|
|
|
| Filpril | |||||||
|
|
|
|
| Pharmacor Quinapril 10 | |||||||
|
|
|
|
| Quinapril-DP | |||||||
|
|
|
|
| Quinapril generichealth | |||||||
| Tablet 20 mg (as hydrochloride) | Oral | 30 | 5 | Accupril | |||||||
|
|
|
|
| Acquin 20 | |||||||
|
|
|
|
| APO-Quinapril | |||||||
|
|
|
|
| Filpril | |||||||
|
|
|
|
| Pharmacor Quinapril 20 | |||||||
|
|
|
|
| Quinapril-GA | |||||||
|
|
|
|
| Quinapril generichealth | |||||||
|
|
|
|
| Quinapril Sandoz | |||||||
Quinapril with Hydrochlorothiazide | Tablet 10 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide | Oral | 30 | 5 | Accuretic 10/12.5mg | |||||||
| Tablet 20 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide | Oral | 30 | 5 | Accuretic 20/12.5mg | |||||||
Quinine | Tablet containing quinine bisulfate 300 mg | Oral | 50 | 2 | Quinbisul | |||||||
| Tablet containing quinine sulfate 300 mg | Oral | 50 | 2 | Quinate | |||||||
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) | Oral | 30 | 2 | Pariet | |||||||
| Tablet containing rabeprazole sodium 10 mg (enteric coated) | Oral | 28 | 5 | Pariet | |||||||
Raloxifene | Tablet containing raloxifene hydrochloride 60 mg | Oral | 28 | 5 | Evista | |||||||
Raltitrexed | Powder for I.V. infusion 2 mg in single use vial | Injection | 3 | 2 | Tomudex | |||||||
Ramipril | Tablet 1.25 mg | Oral | 30 | 5 | APO-Ramipril | |||||||
|
|
|
|
| Chem mart Ramipril | |||||||
|
|
|
|
| Prilace 1.25 | |||||||
|
|
|
|
| Ramace 1.25 mg | |||||||
|
|
|
|
| Ramipril Sandoz | |||||||
|
|
|
|
| Ramipril Winthrop | |||||||
|
|
|
|
| Terry White Chemists Ramipril | |||||||
|
|
|
|
| Tritace 1.25 mg | |||||||
|
|
|
|
| Tryzan Tabs 1.25 | |||||||
| Capsule 1.25 mg | Oral | 30 | 5 | Pharmacor Ramipril 1.25 | |||||||
|
|
|
|
| Ramipril-DP | |||||||
|
|
|
|
| Ramipril generichealth | |||||||
|
|
|
|
| Tryzan Caps 1.25 | |||||||
| Tablet 2.5 mg | Oral | 30 | 5 | APO-Ramipril | |||||||
|
|
|
|
| Chem mart Ramipril | |||||||
|
|
|
|
| Prilace 2.5 | |||||||
|
|
|
|
| Ramace 2.5 mg | |||||||
|
|
|
|
| Ramipril Sandoz | |||||||
|
|
|
|
| Ramipril Winthrop | |||||||
|
|
|
|
| Terry White Chemists Ramipril | |||||||
|
|
|
|
| Tritace 2.5 mg | |||||||
|
|
|
|
| Tryzan Tabs 2.5 | |||||||
| Capsule 2.5 mg | Oral | 30 | 5 | Pharmacor Ramipril 2.5 | |||||||
|
|
|
|
| Ramipril-DP | |||||||
|
|
|
|
| Ramipril generichealth | |||||||
|
|
|
|
| Tryzan Caps 2.5 | |||||||
| Tablet 5 mg | Oral | 30 | 5 | APO-Ramipril | |||||||
|
|
|
|
| Chem mart Ramipril | |||||||
|
|
|
|
| Prilace 5 | |||||||
|
|
|
|
| Ramace 5 mg | |||||||
|
|
|
|
| Ramipril Sandoz | |||||||
|
|
|
|
| Ramipril Winthrop | |||||||
|
|
|
|
| Terry White Chemists Ramipril | |||||||
|
|
|
|
| Tritace 5 mg | |||||||
|
|
|
|
| Tryzan Tabs 5 | |||||||
| Capsule 5 mg | Oral | 30 | 5 | Pharmacor Ramipril 5 | |||||||
|
|
|
|
| Ramipril-DP | |||||||
|
|
|
|
| Ramipril generichealth | |||||||
|
|
|
|
| Tryzan Caps 5 | |||||||
| Tablet 10 mg | Oral | 30 | 5 | APO-Ramipril Chem mart Ramipril Ramipril Sandoz Terry White Chemists Ramipril Tritace Tryzan Tabs 10 | |||||||
| Capsule 10 mg | Oral | 30 | 5 | GenRx Ramipril | |||||||
|
|
|
|
| Pharmacor Ramipril 10 | |||||||
|
|
|
|
| Prilace 10 | |||||||
|
|
|
|
| Ramace 10 mg | |||||||
|
|
|
|
| Ramipril-DP | |||||||
|
|
|
|
| Ramipril generichealth | |||||||
|
|
|
|
| Ramipril Sandoz | |||||||
|
|
|
|
| Ramipril Winthrop | |||||||
|
|
|
|
| Tritace 10 mg | |||||||
|
|
|
|
| Tryzan Caps 10 | |||||||
| Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg | Oral | 1 | .. | Tritace Titration Pack | |||||||
Ramipril with Felodipine | Tablet 2.5 mg-2.5 mg (modified release) | Oral | 30 | 5 | Triasyn 2.5/2.5 | |||||||
| Tablet 5 mg-5 mg (modified release) | Oral | 30 | 5 | Triasyn 5.0/5.0 | |||||||
Ranibizumab | Solution for intravitreal injection 2.3 mg in 0.23 mL | Injection | 1 | 2 | Lucentis | |||||||
Ranitidine | Tablet 150 mg (as hydrochloride) | Oral | 60 | 5 | Ausran | |||||||
|
|
|
|
| Chem mart Ranitidine | |||||||
|
|
|
|
| GenRx Ranitidine | |||||||
|
|
|
|
| Rani 2 | |||||||
|
|
|
|
| Ranihexal | |||||||
|
|
|
|
| Ranoxyl | |||||||
|
|
|
|
| Terry White Chemists Ranitidine | |||||||
|
|
|
|
| Ulcaid | |||||||
|
|
|
|
| Zantac | |||||||
| Tablet, effervescent, 150 mg (as hydrochloride) | Oral | 60 | 5 | Zantac | |||||||
| Tablet 300 mg (as hydrochloride) | Oral | 30 | 5 | Ausran | |||||||
|
|
|
|
| Chem mart Ranitidine | |||||||
|
|
|
|
| GenRx Ranitidine | |||||||
|
|
|
|
| Rani 2 | |||||||
|
|
|
|
| Ranihexal | |||||||
|
|
|
|
| Terry White Chemists Ranitidine | |||||||
|
|
|
|
| Ulcaid | |||||||
|
|
|
|
| Zantac | |||||||
| Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL | Oral | 2 | 5 | Zantac Syrup | |||||||
Reboxetine | Tablet 4 mg (as mesilate) | Oral | 60 | 5 | Edronax | |||||||
Reteplase | Pack containing 2 vials powder for injection 10 units, 2 single use pre-filled syringes with solvent, 2 reconstitution spikes and 2 needles | Injection | 1 | .. | Rapilysin 10 U | |||||||
Rifampicin | Capsule 150 mg | Oral | 10 | .. | Rimycin 150 | |||||||
| Capsule 300 mg | Oral | 10 | .. | Rimycin 300 | |||||||
| Syrup 100 mg per 5 mL, 60 mL | Oral | 1 | .. | Rifadin | |||||||
Riluzole | Tablet 50 mg | Oral | 56 | 5 | Rilutek | |||||||
Risedronic Acid | Tablet containing risedronate sodium 5 mg | Oral | 28 | 5 | Actonel | |||||||
| Tablet containing risedronate sodium 35 mg | Oral | 4 | 5 | Actonel Once-a-Week | |||||||
| Tablet containing risedronate sodium 150 mg | Oral | 1 | 5 | Actonel Once-a-Month | |||||||
| Tablet containing risedronate sodium 30 mg | Oral | 28 | 1 | Actonel | |||||||
Risedronic Acid and Calcium | Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate) | Oral | 1 | 5 | Actonel Combi | |||||||
Risedronic acid and calcium with colecalciferol | Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms | Oral | 1 | 5 | Actonel Combi D | |||||||
Risperidone | Tablet 0.5 mg | Oral | 60 | 2 | APO-Risperidone | |||||||
|
|
|
|
| Ozidal | |||||||
|
|
|
|
| Resdone 0.5 | |||||||
|
|
|
|
| Rispa | |||||||
|
|
|
|
| Risperdal | |||||||
|
|
|
|
| Risperidone-GA | |||||||
|
|
|
|
| Rixadone | |||||||
| Tablet 0.5 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet | |||||||
| Tablet 1 mg | Oral | 60 | 2 | APO-Risperidone | |||||||
|
|
|
|
| Ozidal | |||||||
|
|
|
|
| Resdone 1 | |||||||
|
|
|
|
| Rispa | |||||||
|
|
|
|
| Risperdal | |||||||
|
|
|
|
| Risperidone-GA | |||||||
|
|
|
|
| Risperidone generichealth | |||||||
|
|
|
|
| Rixadone | |||||||
| Tablet 1 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet | |||||||
| Tablet 2 mg | Oral | 60 | 2 | APO-Risperidone | |||||||
|
|
|
|
| Ozidal | |||||||
|
|
|
|
| Resdone 2 | |||||||
|
|
|
|
| Rispa | |||||||
|
|
|
|
| Risperdal | |||||||
|
|
|
|
| Risperidone-GA | |||||||
|
|
|
|
| Risperidone generichealth | |||||||
|
|
|
|
| Rixadone | |||||||
| Tablet 2 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet | |||||||
| Tablet 3 mg | Oral | 60 | 5 | APO-Risperidone | |||||||
|
|
|
|
| Ozidal | |||||||
|
|
|
|
| Resdone 3 | |||||||
|
|
|
|
| Rispa | |||||||
|
|
|
|
| Risperdal | |||||||
|
|
|
|
| Risperidone-GA | |||||||
|
|
|
|
| Risperidone generichealth | |||||||
|
|
|
|
| Rixadone | |||||||
| Tablet 3 mg (orally disintegrating) | Oral | 56 | 5 | Risperdal Quicklet | |||||||
| Tablet 4 mg | Oral | 60 | 5 | APO-Risperidone | |||||||
|
|
|
|
| Ozidal | |||||||
|
|
|
|
| Resdone 4 | |||||||
|
|
|
|
| Rispa | |||||||
|
|
|
|
| Risperdal | |||||||
|
|
|
|
| Risperidone-GA | |||||||
|
|
|
|
| Risperidone generichealth | |||||||
|
|
|
|
| Rixadone | |||||||
| Tablet 4 mg (orally disintegrating) | Oral | 56 | 5 | Risperdal Quicklet | |||||||
| Oral solution 1 mg per mL, 100 mL | Oral | 1 | 2 | Risperdal | |||||||
| I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta | |||||||
| I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta | |||||||
| I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta | |||||||
Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | 2 | 3 | Mabthera | |||||||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | 1 | 3 | Mabthera | |||||||
Rivaroxaban | Tablet 10 mg, 30 | Oral | 1 | .. | Xarelto | |||||||
| Tablet 10 mg | Oral | 10 | .. | Xarelto | |||||||
| Tablet 10 mg, 15 | Oral | 1 | .. | Xarelto | |||||||
Rivastigmine | Capsule 1.5 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon | |||||||
| Capsule 3 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon | |||||||
| Capsule 4.5 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon | |||||||
| Capsule 6 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon | |||||||
| Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL | Oral | 1 | 5 | Exelon | |||||||
| Transdermal patch 9 mg | Transdermal | 30 | 5 | Exelon Patch 5 | |||||||
| Transdermal patch 18 mg | Transdermal | 30 | 5 | Exelon Patch 10 | |||||||
Rizatriptan | Wafer 10 mg (as benzoate) | Oral | 4 | 5 | Maxalt | |||||||
Rosiglitazone | Tablet 4 mg (as maleate) | Oral | 28 | 5 | Avandia | |||||||
| Tablet 8 mg (as maleate) | Oral | 28 | 5 | Avandia | |||||||
Rosiglitazone with Metformin | Tablet 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride | Oral | 56 | 5 | Avandamet | |||||||
| Tablet 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride | Oral | 56 | 5 | Avandamet | |||||||
| Tablet 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride | Oral | 56 | 5 | Avandamet | |||||||
| Tablet 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride | Oral | 56 | 5 | Avandamet | |||||||
Rosuvastatin | Tablet 5 mg (as calcium) | Oral | 30 | 5 | Crestor | |||||||
| Tablet 10 mg (as calcium) | Oral | 30 | 5 | Crestor | |||||||
| Tablet 20 mg (as calcium) | Oral | 30 | 5 | Crestor | |||||||
| Tablet 40 mg (as calcium) | Oral | 30 | 5 | Crestor | |||||||
Roxithromycin | Tablet for oral suspension 50 mg | Oral | 10 | 1 | Rulide D | |||||||
| Tablet 150 mg | Oral | 10 | 1 | APO-Roxithromycin Biaxsig Chem mart Roxithromycin | |||||||
|
|
|
|
| Roxar 150 | |||||||
|
|
|
|
| Roxide | |||||||
|
|
|
|
| Roximycin | |||||||
|
|
|
|
| Roxithromycin-GA | |||||||
|
|
|
|
| Rulide Terry White Chemists Roxithromycin | |||||||
| Tablet 300 mg | Oral | 5 | 1 | APO-Roxithromycin Biaxsig Chem mart Roxithromycin | |||||||
|
|
|
|
| Roxar 300 | |||||||
|
|
|
|
| Roxide | |||||||
|
|
|
|
| Roximycin | |||||||
|
|
|
|
| Roxithromycin-GA | |||||||
|
|
|
|
| Rulide Terry White Chemists Roxithromycin | |||||||
Salbutamol | Oral solution 2 mg (as sulfate) per 5 mL, 150 mL | Oral | 2 | 5 | Ventolin | |||||||
| Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler) | Inhalation by mouth | 200 | 5 | Ventolin Rotacaps | |||||||
| Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 2 | 5 | Airomir | |||||||
|
|
|
|
| Asmol CFC-free | |||||||
|
|
|
|
| Ventolin CFC-free | |||||||
| Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | 2 | 5 | Airomir Autohaler | |||||||
| Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | 2 | 5 | Asmol 2.5 uni-dose Butamol 2.5 | |||||||
|
|
|
|
| GenRx Salbutamol | |||||||
|
|
|
|
| Pfizer Australia Pty Ltd | |||||||
|
|
|
|
| Pharmacor Salbutamol 2.5 | |||||||
|
|
|
|
| Salbutamol-GA | |||||||
|
|
|
|
| Salbutamol Sandoz | |||||||
|
|
|
|
| Ventolin Nebules | |||||||
| Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | 2 | 5 | Asmol 5 uni-dose Butamol 5 GenRx Salbutamol Pharmacor Salbutamol 5 Salbutamol-GA Salbutamol Sandoz Ventolin Nebules | |||||||
|
|
|
|
| ||||||||
|
|
|
|
| ||||||||
|
|
|
|
| ||||||||
|
|
|
|
| ||||||||
|
|
|
|
| ||||||||
| Nebuliser solution 5 mg (as sulfate) per mL, 30 mL | Inhalation | 2 | 2 | Pfizer Australia Pty Ltd | |||||||
Salcatonin | Injection 50 I.U. in 1 mL ampoule | Injection | 30 | 5 | Miacalcic 50 | |||||||
| Injection 100 I.U. in 1 mL ampoule | Injection | 15 | 5 | Miacalcic 100 | |||||||
Salmeterol | Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Serevent Accuhaler | |||||||
Selegiline | Tablet containing selegiline hydrochloride 5 mg | Oral | 100 | 5 | Eldepryl Selgene | |||||||
Sertraline | Tablet 50 mg (as hydrochloride) | Oral | 30 | 5 | Chem mart Sertraline | |||||||
|
|
|
|
| Concorz | |||||||
|
|
|
|
| Eleva 50 | |||||||
|
|
|
|
| GenRx Sertraline | |||||||
|
|
|
|
| Sertra 50 | |||||||
|
|
|
|
| Sertraline 50 | |||||||
|
|
|
|
| Sertraline-GA | |||||||
|
|
|
|
| Sertraline generichealth | |||||||
|
|
|
|
| Sertraline Winthrop | |||||||
|
|
|
|
| Setrona | |||||||
|
|
|
|
| Terry White Chemists Sertraline | |||||||
|
|
|
|
| Xydep 50 | |||||||
|
|
|
|
| Zoloft | |||||||
| Tablet 100 mg (as hydrochloride) | Oral | 30 | 5 | Chem mart Sertraline | |||||||
|
|
|
|
| Concorz | |||||||
|
|
|
|
| Eleva 100 | |||||||
|
|
|
|
| GenRx Sertraline | |||||||
|
|
|
|
| Sertra 100 | |||||||
|
|
|
|
| Sertraline 100 | |||||||
|
|
|
|
| Sertraline-GA | |||||||
|
|
|
|
| Sertraline generichealth | |||||||
|
|
|
|
| Setrona | |||||||
|
|
|
|
| Terry White Chemists Sertraline | |||||||
|
|
|
|
| Xydep 100 | |||||||
|
|
|
|
| Zoloft | |||||||
Sevelamer | Tablet containing sevelamer hydrochloride 800 mg | Oral | 180 | 5 | Renagel | |||||||
Silver sulfadiazine | Cream 10 mg per g, 50 g | Application | 1 | . . | Flamazine | |||||||
Simvastatin | Tablet 5 mg | Oral | 30 | 5 | Simvabell | |||||||
|
|
|
|
| Simvahexal | |||||||
|
|
|
|
| Simvasyn | |||||||
|
|
|
|
| Zimstat | |||||||
|
|
|
|
| Zocor | |||||||
| Tablet 10 mg | Oral | 30 | 5 | APO-Simvastatin | |||||||
|
|
|
|
| Chem mart Simvastatin | |||||||
|
|
|
|
| GenRx Simvastatin | |||||||
|
|
|
|
| Lipex 10 | |||||||
|
|
|
|
| Ransim | |||||||
|
|
|
|
| Simvabell | |||||||
|
|
|
|
| Simvahexal | |||||||
|
|
|
|
| Simvar 10 | |||||||
|
|
|
|
| Simvastatin-DP | |||||||
|
|
|
|
| Simvastatin-GA 10 | |||||||
|
|
|
|
| Simvastatin generichealth | |||||||
|
|
|
|
| Simvastatin-Spirit 10 | |||||||
|
|
|
|
| Simvastatin Winthrop | |||||||
|
|
|
|
| Simvasyn | |||||||
|
|
|
|
| Terry White Chemists Simvastatin | |||||||
|
|
|
|
| Zimstat | |||||||
|
|
|
|
| Zocor | |||||||
| Tablet 20 mg | Oral | 30 | 5 | APO-Simvastatin | |||||||
|
|
|
|
| Chem mart Simvastatin | |||||||
|
|
|
|
| GenRx Simvastatin | |||||||
|
|
|
|
| Lipex 20 | |||||||
|
|
|
|
| Ransim | |||||||
|
|
|
|
| Simvabell | |||||||
|
|
|
|
| Simvahexal | |||||||
|
|
|
|
| Simvar 20 | |||||||
|
|
|
|
| Simvastatin-DP | |||||||
|
|
|
|
| Simvastatin-GA 20 | |||||||
|
|
|
|
| Simvastatin generichealth | |||||||
|
|
|
|
| Simvastatin-Spirit 20 | |||||||
|
|
|
|
| Simvastatin Winthrop | |||||||
|
|
|
|
| Simvasyn | |||||||
|
|
|
|
| Terry White Chemists Simvastatin | |||||||
|
|
|
|
| Zimstat | |||||||
|
|
|
|
| Zocor | |||||||
| Tablet 40 mg | Oral | 30 | 5 | APO-Simvastatin | |||||||
|
|
|
|
| Chem mart Simvastatin | |||||||
|
|
|
|
| GenRx Simvastatin | |||||||
|
|
|
|
| Lipex 40 | |||||||
|
|
|
|
| Ransim | |||||||
|
|
|
|
| Simvabell | |||||||
|
|
|
|
| Simvahexal | |||||||
|
|
|
|
| Simvar 40 | |||||||
|
|
|
|
| Simvastatin-DP | |||||||
|
|
|
|
| Simvastatin-GA 40 | |||||||
|
|
|
|
| Simvastatin generichealth | |||||||
|
|
|
|
| Simvastatin-Spirit 40 | |||||||
|
|
|
|
| Simvastatin Winthrop | |||||||
|
|
|
|
| Simvasyn | |||||||
|
|
|
|
| Terry White Chemists Simvastatin | |||||||
|
|
|
|
| Zimstat | |||||||
|
|
|
|
| Zocor | |||||||
| Tablet 80 mg | Oral | 30 | 5 | APO-Simvastatin | |||||||
|
|
|
|
| Chem mart Simvastatin | |||||||
|
|
|
|
| GenRx Simvastatin | |||||||
|
|
|
|
| Lipex 80 | |||||||
|
|
|
|
| Ransim | |||||||
|
|
|
|
| Simvabell | |||||||
|
|
|
|
| Simvahexal | |||||||
|
|
|
|
| Simvar 80 | |||||||
|
|
|
|
| Simvastatin-DP | |||||||
|
|
|
|
| Simvastatin-GA 80 | |||||||
|
|
|
|
| Simvastatin generichealth | |||||||
|
|
|
|
| Simvastatin-Spirit 80 | |||||||
|
|
|
|
| Simvastatin Winthrop | |||||||
|
|
|
|
| Simvasyn | |||||||
|
|
|
|
| Terry White Chemists Simvastatin | |||||||
|
|
|
|
| Zimstat | |||||||
|
|
|
|
| Zocor | |||||||
Sirolimus | Tablet 1 mg | Oral | 100 | 3 | Rapamune | |||||||
| Tablet 2 mg | Oral | 100 | 3 | Rapamune | |||||||
| Oral solution 1 mg per mL, 60 mL | Oral | 1 | 3 | Rapamune | |||||||
Sitagliptin | Tablet 25 mg (as phosphate monohydrate) | Oral | 28 | 5 | Januvia | |||||||
| Tablet 50 mg (as phosphate monohydrate) | Oral | 28 | 5 | Januvia | |||||||
| Tablet 100 mg (as phosphate monohydrate) | Oral | 28 | 5 | Januvia | |||||||
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride | Oral | 56 | 5 | Janumet | |||||||
| Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride | Oral | 56 | 5 | Janumet | |||||||
| Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride | Oral | 56 | 5 | Janumet | |||||||
Sodium Acid Phosphate | Tablet, compound effervescent, equivalent to 500 mg phosphorus | Oral | 100 | 5 | Phosphate Sandoz | |||||||
Sodium bicarbonate | Capsule 840 mg | Oral | 100 | 2 | Sodibic | |||||||
Sodium Chloride | Injection 9 mg per mL, 10 mL | Injection/solvent for injectables | 5 | 1 | Pfizer Australia Pty Ltd | |||||||
| I.V. infusion 38.5 mmol per 250 mL, 250 mL | Injection | 5 | 1 | B. Braun Australia Pty Ltd | |||||||
|
|
|
|
| Sodium Chloride 0.9% Freeflex | |||||||
| I.V. infusion 77 mmol per 500 mL, 500 mL | Injection | 5 | 1 | B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited | |||||||
| I.V. infusion 154 mmol per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Ltd | |||||||
|
|
|
|
| B. Braun Australia Pty Ltd | |||||||
|
|
|
|
| Pharmatel Fresenius Kabi Pty Limited | |||||||
| I.V. infusion 513 mmol per L, 1 L | Injection | 2 | 1 | Baxter Healthcare Pty Ltd | |||||||
Sodium Chloride Compound | I.V. infusion containing approximately 148 mmol sodium (as chloride), 4 mmol potassium (as chloride), 2 mmol calcium (as chloride) and 156 mmol chloride per L, 1 L | Injection | 4 | 1 | Baxter Healthcare Pty Ltd | |||||||
Sodium Chloride with Glucose | I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Ltd | |||||||
| I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | Baxter Healthcare Pty Ltd | |||||||
| I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | Baxter Healthcare Pty Ltd | |||||||
Sodium Lactate Compound | I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), | Injection | 5 | 1 | B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited | |||||||
| I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Ltd B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited | |||||||
Sorafenib | Tablet 200 mg (as tosylate) | Oral | 120 | 2 | Nexavar | |||||||
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 | Rectal | 2 | 2 | Microlax | |||||||
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Oral | 60 | 5 | GenRx Sotalol | |||||||
|
|
|
|
| Solavert | |||||||
|
|
|
|
| Sotacor | |||||||
|
|
|
|
| Sotalol Sandoz | |||||||
| Tablet containing sotalol hydrochloride 160 mg | Oral | 60 | 5 | Cardol | |||||||
|
|
|
|
| Chem mart Sotalol | |||||||
|
|
|
|
| GenRx Sotalol | |||||||
|
|
|
|
| Solavert | |||||||
|
|
|
|
| Sotacor | |||||||
|
|
|
|
| Sotalol Sandoz | |||||||
|
|
|
|
| Terry White Chemists Sotalol | |||||||
Soy lecithin | Eye spray 10 mg per mL, 10 mL | Application | 2 | 5 | tearsagain | |||||||
Soy protein and fat formula with vitamins and minerals — carbohydrate free | Oral liquid 384 mL (RCF) | Oral | 120 | 5 | RCF | |||||||
Spironolactone | Tablet 25 mg | Oral | 100 | 5 | Aldactone Spiractin 25 | |||||||
| Tablet 100 mg | Oral | 100 | 5 | Aldactone Spiractin 100 | |||||||
Sterculia with Frangula Bark | Granules 620 mg-80 mg per g, 500 g | Oral | 1 | 1 | Normacol Plus | |||||||
Strontium | Sachet containing granules for oral suspension containing strontium ranelate 2 g | Oral | 28 | 5 | Protos 2 g | |||||||
Sucralfate | Tablet equivalent to 1 g anhydrous sucralfate | Oral | 120 | 2 | Carafate Ulcyte | |||||||
Sulfacetamide | Eye drops containing sulfacetamide sodium 100 mg per mL, 15 mL | Application to the eye | 1 | 2 | Bleph 10 | |||||||
Sulfasalazine | Tablet 500 mg | Oral | 200 | 5 | Salazopyrin | |||||||
| Tablet 500 mg (enteric coated) | Oral | 200 | 5 | Pyralin EN Salazopyrin-EN | |||||||
Sulindac | Tablet 100 mg | Oral | 100 | 3 | Aclin | |||||||
| Tablet 200 mg | Oral | 50 | 3 | Aclin 200 | |||||||
Sulthiame | Tablet 50 mg | Oral | 200 | 2 | Ospolot | |||||||
| Tablet 200 mg | Oral | 200 | 2 | Ospolot | |||||||
Sumatriptan | Tablet 50 mg (as succinate) | Oral | 4 | 5 | Imigran | |||||||
|
|
|
|
| Sumagran 50 | |||||||
|
|
|
|
| Sumatab | |||||||
| Tablet (fast disintegrating) 50 mg (as succinate) | Oral | 4 | 5 | Imigran FDT | |||||||
| Nasal spray 20 mg in 0.1 mL single dose unit | Nasal | 2 | 5 | Imigran | |||||||
Sunitinib | Capsule 12.5 mg (as malate) Capsule 25 mg (as malate) Capsule 50 mg (as malate) | Oral Oral Oral | 28 28 28 | 1 1 1 | Sutent Sutent Sutent | |||||||
Tacrolimus | Capsule 500 micrograms | Oral | 100 | 3 | Prograf | |||||||
| Capsule 1 mg | Oral | 100 | 3 | Prograf | |||||||
| Capsule 5 mg | Oral | 50 | 3 | Prograf | |||||||
Tamoxifen | Tablet 10 mg (as citrate) | Oral | 60 | 5 | Genox 10 | |||||||
| Tablet 20 mg (as citrate) | Oral | 60 | 5 | Chem mart Tamoxifen | |||||||
|
|
|
|
| Genox 20 | |||||||
|
|
|
|
| GenRx Tamoxifen | |||||||
|
|
|
|
| Nolvadex-D | |||||||
|
|
|
|
| Tamosin | |||||||
|
|
|
|
| Tamoxen 20 mg | |||||||
|
|
|
|
| Tamoxifen Sandoz | |||||||
|
|
|
|
| Terry White Chemists Tamoxifen | |||||||
Telmisartan | Tablet 40 mg | Oral | 28 | 5 | Micardis | |||||||
| Tablet 80 mg | Oral | 28 | 5 | Micardis | |||||||
Telmisartan with Hydrochlorothiazide | Tablet 40 mg-12.5 mg | Oral | 28 | 5 | Micardis Plus 40/12.5 mg | |||||||
| Tablet 80 mg-12.5 mg | Oral | 28 | 5 | Micardis Plus 80/12.5 mg | |||||||
| Tablet 80 mg-25 mg | Oral | 28 | 5 | Micardis Plus 80/25 mg | |||||||
Temazepam | Tablet 10 mg | Oral | 25 | .. | APO-Temazepam Normison Temaze Temtabs | |||||||
Temozolomide | Capsule 5 mg | Oral | 15 | 2 | Temodal | |||||||
| Capsule 20 mg | Oral | 15 | 2 | Temodal | |||||||
| Capsule 100 mg | Oral | 15 | 2 | Temodal | |||||||
| Capsule 140 mg | Oral | 15 | 2 | Temodal | |||||||
| Capsule 250 mg | Oral | 5 | 5 | Temodal | |||||||
Tenecteplase | Powder for injection 40 mg with solvent | Injection | 1 | .. | Metalyse | |||||||
| Powder for injection 50 mg with solvent | Injection | 1 | .. | Metalyse | |||||||
Terbinafine | Tablet 250 mg (as hydrochloride) | Oral | 42 | .. | GenRx Terbinafine | |||||||
|
|
|
|
| Lamisil (Novartis Pharmaceuticals Australia Pty Limited) | |||||||
|
|
|
|
| Sebifin 250 | |||||||
|
|
|
|
| Tamsil | |||||||
|
|
|
|
| Terbihexal | |||||||
|
|
|
|
| Terbinafine 250 | |||||||
|
|
|
|
| Terbinafine-DP | |||||||
|
|
|
|
| Zabel | |||||||
| Cream containing terbinafine hydrochloride 10 mg per g, 15 g | Application | 2 | 3 | Lamisil (Novartis Consumer Health Australasia Pty Ltd) | |||||||
Terbutaline | Injection containing terbutaline sulfate 500 micrograms in 1mL | Injection | 5 | .. | Bricanyl | |||||||
| Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Bricanyl Turbuhaler | |||||||
Teriparatide | Injection 250 micrograms per mL, 2.4 mL in multi-dose | Injection | 1 | 5 | Forteo | |||||||
Testosterone | Capsule containing testosterone undecanoate 40 mg | Oral | 60 | 5 | Andriol Testocaps | |||||||
| Subcutaneous implant 100 mg | Implantation | 6 | .. | Schering-Plough Pty Limited | |||||||
| Injection containing testosterone enanthate 250 mg in 1 mL | Injection | 3 | 3 | Primoteston Depot | |||||||
| Injection containing testosterone esters (20 mg testosterone propionate, 40 mg testosterone phenylpropionate, 40 mg testosterone isocaproate) in 1 mL | Injection | 3 | 3 | Sustanon 100 | |||||||
| I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL | Injection | 1 | 1 | Reandron 1000 | |||||||
| Subcutaneous implant 200 mg | Implantation | 3 | .. | Schering-Plough Pty Limited | |||||||
| Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, 100 mg testosterone decanoate) | Injection | 3 | 3 | Sustanon 250 | |||||||
| Transdermal gel 50 mg in 5 g sachet, 30 | Transdermal | 1 | 5 | Testogel | |||||||
| Transdermal patches 12.2 mg, 60 | Transdermal | 1 | 5 | Androderm | |||||||
| Transdermal patches 24.3 mg, 30 | Transdermal | 1 | 5 | Androderm | |||||||
Tetrabenazine | Tablet 25 mg | Oral | 112 | 5 | Orphan Australia Pty Ltd | |||||||
Tetracosactrin | Compound depot injection 1 mg in 1 mL | Injection | 5 | 5 | Synacthen Depot 1 mg/1 mL | |||||||
Theophylline | Tablet 200 mg (sustained release) | Oral | 100 | 5 | Nuelin-SR 200 | |||||||
| Tablet 250 mg (sustained release) | Oral | 100 | 5 | Nuelin-SR 250 | |||||||
| Tablet 300 mg (sustained release) | Oral | 100 | 5 | Nuelin-SR 300 | |||||||
| Oral solution 133.3 mg per 25 mL, 500 mL | Oral | 1 | 5 | Nuelin | |||||||
Thiamine | Tablet containing thiamine hydrochloride 100 mg | Oral | 100 | 2 | Betamin | |||||||
Thioguanine | Tablet 40 mg | Oral | 25 | 1 | Lanvis | |||||||
Thiotepa | Powder for injection 15 mg | Injection/intravesical | 2 | 1 | Sigma Pharmaceuticals (Australia) Pty Ltd | |||||||
Thyrotropin Alfa | Powder for injection 0.9 mg, 2 | Injection | 1 | .. | Thyrogen | |||||||
Thyroxine | Tablet containing 50 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine | |||||||
| Tablet containing 75 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine | |||||||
| Tablet containing 100 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine | |||||||
| Tablet containing 200 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine | |||||||
Tiagabine | Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril | |||||||
| Tablet 10 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril | |||||||
| Tablet 15 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril | |||||||
Tiaprofenic Acid | Tablet 300 mg | Oral | 60 | 3 | Surgam | |||||||
Ticarcillin with Clavulanic Acid | Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Timentin | |||||||
Ticlopidine | Tablet containing ticlopidine hydrochloride 250 mg | Oral | 60 | 5 | Tilodene | |||||||
Tiludronic Acid | Tablet 200 mg (as tiludronate disodium) | Oral | 56 | 2 | Skelid | |||||||
Timolol | Eye gel 1 mg (as maleate) per g, 5 g | Application to the eye | 1 | 5 | Nyogel | |||||||
| Eye drops 2.5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Tenopt Timoptol | |||||||
| Eye drops 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Tenopt Timoptol | |||||||
| Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Timoptol XE | |||||||
| Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Timoptol XE | |||||||
Tinidazole | Tablet 500 mg | Oral | 4 | .. | Fasigyn Simplotan | |||||||
Tiotropium | Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler) | Inhalation by mouth | 30 | 5 | Spiriva | |||||||
Tirofiban | Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL | Injection | 1 | 2 | Aggrastat | |||||||
Tobramycin | Injection 80 mg (as sulfate) in 2 mL | Injection | 10 | 1 | Hospira Pty Limited | |||||||
| Injection 80 mg (as sulfate) in 2 mL (without preservative) | Injection | 10 | 1 | Pfizer Australia Pty Ltd | |||||||
| Injection 500 mg (as sulfate) in 5 mL (without preservative) | Injection | 10 | 1 | Tobra-Day | |||||||
| Eye drops 3 mg per mL, 5 mL | Application to the eye | 1 | 2 | Tobrex | |||||||
| Eye ointment 3 mg per g, 3.5 g | Application to the eye | 1 | .. | Tobrex | |||||||
Topiramate | Tablet 25 mg | Oral | 60 | 5 | APO-Topiramate | |||||||
|
|
|
|
| Epiramax 25 | |||||||
|
|
|
|
| Tamate | |||||||
|
|
|
|
| Topamax | |||||||
|
|
|
|
| Topiramate Sandoz | |||||||
| Tablet 50 mg | Oral | 60 | 5 | APO-Topiramate | |||||||
|
|
|
|
| Epiramax 50 | |||||||
|
|
|
|
| Tamate | |||||||
|
|
|
|
| Topamax | |||||||
|
|
|
|
| Topiramate Sandoz | |||||||
| Tablet 100 mg | Oral | 60 | 5 | APO-Topiramate | |||||||
|
|
|
|
| Epiramax 100 | |||||||
|
|
|
|
| Tamate | |||||||
|
|
|
|
| Topamax | |||||||
|
|
|
|
| Topiramate Sandoz | |||||||
| Tablet 200 mg | Oral | 60 | 5 | APO-Topiramate | |||||||
|
|
|
|
| Epiramax 200 | |||||||
|
|
|
|
| Tamate | |||||||
|
|
|
|
| Topamax | |||||||
|
|
|
|
| Topiramate Sandoz | |||||||
| Capsule 15 mg | Oral | 60 | 5 | Topamax Sprinkle | |||||||
| Capsule 25 mg | Oral | 60 | 5 | Topamax Sprinkle | |||||||
| Capsule 50 mg | Oral | 60 | 5 | Topamax Sprinkle | |||||||
Topotecan | Powder for I.V. infusion 4 mg (as hydrochloride) | Injection | 5 | 1 | Hycamtin | |||||||
Toremifene | Tablet 60 mg (as citrate) | Oral | 30 | 5 | Fareston | |||||||
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Chem mart Tramadol | |||||||
|
|
|
|
| GenRx Tramadol | |||||||
|
|
|
|
| Lodam 50 | |||||||
|
|
|
|
| Terry White Chemists Tramadol | |||||||
|
|
|
|
| Tramal | |||||||
|
|
|
|
| Tramedo | |||||||
|
|
|
|
| Zydol | |||||||
| Tablet (sustained release) containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Tramal SR 50 | |||||||
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR | |||||||
|
|
|
|
| Lodam SR 100 | |||||||
|
|
|
|
| Terry White Chemists Tramadol SR | |||||||
|
|
|
|
| Tramahexal SR | |||||||
|
|
|
|
| Tramal SR 100 | |||||||
|
|
|
|
| Tramedo SR 100 | |||||||
|
|
|
|
| Zydol SR 100 | |||||||
| Tablet (extended release) containing tramadol hydrochloride 100 mg | Oral | 10 | .. | Durotram XR | |||||||
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR | |||||||
|
|
|
|
| Lodam SR 150 | |||||||
|
|
|
|
| Terry White Chemists Tramadol SR | |||||||
|
|
|
|
| Tramahexal SR | |||||||
|
|
|
|
| Tramal SR 150 | |||||||
|
|
|
|
| Tramedo SR 150 | |||||||
|
|
|
|
| Zydol SR 150 | |||||||
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR | |||||||
|
|
|
|
| Lodam SR 200 | |||||||
|
|
|
|
| Terry White Chemists Tramadol SR | |||||||
|
|
|
|
| Tramahexal SR | |||||||
|
|
|
|
| Tramal SR 200 | |||||||
|
|
|
|
| Tramedo SR 200 | |||||||
|
|
|
|
| Zydol SR 200 | |||||||
| Tablet (extended release) containing tramadol hydrochloride 200 mg | Oral | 10 | .. | Durotram XR | |||||||
| Tablet (extended release) containing tramadol hydrochloride 300 mg | Oral | 10 | .. | Durotram XR | |||||||
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | 1 | .. | Tramal | |||||||
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | 5 | .. | Tramahexal Tramal 100 | |||||||
Trandolapril | Capsule 500 micrograms | Oral | 28 | 5 | APO-Trandolapril | |||||||
|
|
|
|
| Dolapril 0.5 | |||||||
|
|
|
|
| Gopten | |||||||
|
|
|
|
| Tranalpha | |||||||
|
|
|
|
| Trandolapril-DP | |||||||
|
|
|
|
| Trandolapril generichealth | |||||||
| Capsule 1 mg | Oral | 28 | 5 | APO-Trandolapril | |||||||
|
|
|
|
| Dolapril 1 | |||||||
|
|
|
|
| Gopten | |||||||
|
|
|
|
| Tranalpha | |||||||
|
|
|
|
| Trandolapril-DP | |||||||
|
|
|
|
| Trandolapril generichealth | |||||||
| Capsule 2 mg | Oral | 28 | 5 | APO-Trandolapril | |||||||
|
|
|
|
| Dolapril 2 | |||||||
|
|
|
|
| Gopten | |||||||
|
|
|
|
| Tranalpha | |||||||
|
|
|
|
| Trandolapril-DP | |||||||
|
|
|
|
| Trandolapril generichealth | |||||||
| Capsule 4 mg | Oral | 28 | 5 | APO-Trandolapril | |||||||
|
|
|
|
| Dolapril 4 | |||||||
|
|
|
|
| Gopten | |||||||
|
|
|
|
| Tranalpha | |||||||
|
|
|
|
| Trandolapril-DP | |||||||
|
|
|
|
| Trandolapril generichealth | |||||||
Trandolapril with Verapamil | Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release) | Oral | 28 | 5 | Tarka 2/180 | |||||||
| Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release) | Oral | 28 | 5 | Tarka 4/240 | |||||||
Tranexamic Acid | Tablet 500 mg | Oral | 100 | 2 | Cyklokapron | |||||||
Tranylcypromine | Tablet 10 mg (as sulfate) | Oral | 50 | 2 | Parnate | |||||||
Travoprost | Eye drops 40 micrograms per mL, 2.5 mL | Application to the eye | 1 | 5 | Travatan | |||||||
Travoprost with Timolol | Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Duotrav | |||||||
Triamcinolone | Injection containing triamcinolone acetonide 10 mg in 1 mL | Injection | 5 | .. | Kenacort-A10 | |||||||
| Cream containing triamcinolone acetonide 200 micrograms per g, 100 g | Application | 2 | .. | Aristocort 0.02% Tricortone | |||||||
| Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g | Application | 2 | .. | Aristocort 0.02% Tricortone | |||||||
Triamcinolone with Neomycin, Gramicidin and Nystatin | Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL | Application to the ear | 1 | 2 | Kenacomb Otic Otocomb Otic | |||||||
| Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g | Application to the ear | 1 | 2 | Kenacomb Otic Otocomb Otic | |||||||
Trifluoperazine | Tablet 1 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine | |||||||
| Tablet 2 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine | |||||||
| Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine | |||||||
Triglycerides, long chain with glucose polymer | Oral liquid 250 mL, 18 (ProZero) | Oral | 6 | 5 | ProZero | |||||||
| Oral liquid 1 L, 6 (ProZero) | Oral | 4 | 5 | ProZero | |||||||
Triglycerides, medium chain | Oil 500 mL (MCT Oil) | Oral | 2 | 5 | MCT Oil | |||||||
Triglycerides, medium chain and long chain with glucose polymer | Oral powder 400 g (Duocal) | Oral | 8 | 5 | Duocal | |||||||
Triglycerides — medium chain, formula | Sachets containing oral powder 16 g, 25 (MCT Pro-Cal) | Oral | 4 | 5 | MCT Pro-Cal | |||||||
| Oral powder 400 g (Monogen) | Oral | 8 | 5 | Monogen | |||||||
| Oral powder 420 g (Caprilon) | Oral | 8 | 5 | Caprilon | |||||||
Trimethoprim | Tablet 300 mg | Oral | 7 | 1 | Alprim Triprim | |||||||
Trimethoprim with Sulfamethoxazole | Tablet 80 mg-400 mg | Oral | 10 | 1 | Resprim | |||||||
| Tablet 160 mg-800 mg | Oral | 10 | 1 | Bactrim DS | |||||||
|
|
|
|
| Resprim Forte | |||||||
|
|
|
|
| Septrin Forte | |||||||
| Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL | Oral | 1 | 1 | Bactrim Septrin | |||||||
Triptorelin | Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles | Injection Injection | 1 1 | 5 1 | Diphereline Diphereline | |||||||
Tropisetron | Capsule 5 mg (as hydrochloride) | Oral | 2 | .. | Navoban | |||||||
| I.V. injection 5 mg (as hydrochloride) in 5 mL | Injection | 1 | .. | Navoban | |||||||
Tyrosine with carbohydrate | Sachets of oral powder 4 g containing 1 g tyrosine, 30 (Tyrosine Amino Acid Supplement) | Oral | 4 | 5 | Tyrosine Amino Acid Supplement | |||||||
Ursodeoxycholic Acid | Capsule 250 mg | Oral | 200 | 2 | Ursofalk | |||||||
Ustekinumab | Injection 45 mg in 0.5 mL | Injection | 1 | 1 | Stelara | |||||||
Valaciclovir | Tablet 500 mg (as hydrochloride) | Oral | 20 | .. | Valtrex | |||||||
Valine with carbohydrate | Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine Amino Acid Supplement) | Oral | 4 | 5 | Valine Amino Acid Supplement | |||||||
| Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000 Amino Acid Supplement) | Oral | 4 | 5 | Valine 1000 Amino Acid Supplement | |||||||
Valproic Acid | Tablet, crushable, containing sodium valproate 100 mg | Oral | 200 | 2 | Epilim | |||||||
| Tablet (enteric coated) containing sodium valproate 200 mg | Oral | 200 | 2 | Epilim EC | |||||||
|
|
|
|
| Sodium Valproate Sandoz | |||||||
|
|
|
|
| Valprease 200 | |||||||
|
|
|
|
| Valpro 200 | |||||||
|
|
|
|
| Valproate Winthrop EC 200 | |||||||
| Tablet (enteric coated) containing sodium valproate 500 mg | Oral | 200 | 2 | Epilim EC | |||||||
|
|
|
|
| Sodium Valproate Sandoz | |||||||
|
|
|
|
| Valprease 500 | |||||||
|
|
|
|
| Valpro 500 | |||||||
|
|
|
|
| Valproate Winthrop EC 500 | |||||||
| Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL | Oral | 2 | 2 | Epilim Liquid | |||||||
| Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL | Oral | 2 | 2 | Epilim Syrup | |||||||
Valsartan | Tablet 40 mg | Oral | 28 | . . | Diovan | |||||||
| Tablet 80 mg | Oral | 28 | 5 | Diovan | |||||||
| Tablet 160 mg | Oral | 28 | 5 | Diovan | |||||||
| Tablet 320 mg | Oral | 28 | 5 | Diovan | |||||||
Valsartan with hydrochlorothiazide | Tablet 80 mg-12.5 mg | Oral | 28 | 5 | Co-Diovan 80/12.5 | |||||||
| Tablet 160 mg-12.5 mg | Oral | 28 | 5 | Co-Diovan 160/12.5 | |||||||
| Tablet 160 mg-25 mg | Oral | 28 | 5 | Co-Diovan 160/25 | |||||||
| Tablet 320 mg-12.5 mg | Oral | 28 | 5 | Co-Diovan 320/12.5 | |||||||
| Tablet 320 mg-25 mg | Oral | 28 | 5 | Co-Diovan 320/25 | |||||||
Vancomycin | Capsule 125 mg (125,000 I.U.) (as hydrochloride) | Oral | 40 | .. | Vancocin | |||||||
| Capsule 250 mg (250,000 I.U.) (as hydrochloride) | Oral | 40 | .. | Vancocin | |||||||
| Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | 2 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz | |||||||
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | 1 | .. | Hospira Pty Limited Vancomycin Sandoz | |||||||
Varenicline | Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack | Oral | 1 | .. | Champix | |||||||
| Tablet 1 mg (as tartrate) | Oral | 112 | .. | Champix | |||||||
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Oral | 28 | .. | Efexor-XR | |||||||
| Capsule (modified release) 75 mg (as hydrochloride) | Oral | 28 | 5 | Efexor-XR | |||||||
| Capsule (modified release) 150 mg (as hydrochloride) | Oral | 28 | 5 | Efexor-XR | |||||||
Verapamil | Tablet containing verapamil hydrochloride 40 mg | Oral | 100 | 5 | Anpec 40 Isoptin | |||||||
| Tablet containing verapamil hydrochloride 80 mg | Oral | 100 | 5 | Anpec 80 Isoptin | |||||||
| Tablet containing verapamil hydrochloride 120 mg | Oral | 100 | 5 | Isoptin | |||||||
| Tablet containing verapamil hydrochloride 160 mg | Oral | 60 | 5 | Isoptin | |||||||
| Tablet containing verapamil hydrochloride 180 mg (sustained release) | Oral | 30 | 5 | Cordilox 180 SR Isoptin 180 SR | |||||||
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Oral | 30 | 5 | Anpec SR Cordilox SR Isoptin SR | |||||||
| Capsule containing verapamil hydrochloride 160 mg (sustained release) | Oral | 30 | 5 | Veracaps SR | |||||||
| Capsule containing verapamil hydrochloride 240 mg (sustained release) | Oral | 30 | 5 | Veracaps SR | |||||||
| Injection containing verapamil hydrochloride 5 mg in 2 mL | Injection | 5 | .. | Isoptin | |||||||
Verteporfin | Powder for I.V. infusion 15 mg | Injection | 1 | .. | Visudyne | |||||||
Vigabatrin | Tablet 500 mg | Oral | 100 | 5 | Sabril | |||||||
| Oral powder, sachet 500 mg | Oral | 60 | 5 | Sabril | |||||||
Vinblastine | Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL | Injection | 5 | .. | Hospira Pty Limited | |||||||
Vincristine | I.V. injection containing vincristine sulfate 1 mg in 1 mL | Injection | 10 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd | |||||||
Vinorelbine | Capsule 20 mg (as tartrate) | Oral | 20 | 2 | Navelbine | |||||||
| Capsule 30 mg (as tartrate) | Oral | 16 | 2 | Navelbine | |||||||
| Solution for I.V. infusion 10 mg (as tartrate) in 1 mL | Injection | 16 | 2 | Hospira Pty Limited Navelbine Vinorelbine Link Vinorelbine Ebewe | |||||||
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Injection | 4 | 2 | Hospira Pty Limited Navelbine Vinorelbine Link Vinorelbine Ebewe | |||||||
Voriconazole | Tablet 50 mg | Oral | 56 | 2 | Vfend | |||||||
| Tablet 200 mg | Oral | 56 | 2 | Vfend | |||||||
| Powder for oral suspension 40 mg per mL, 70 mL | Oral | 4 | 2 | Vfend | |||||||
Warfarin | Tablet containing warfarin sodium 1 mg | Oral | 50 | 2 | Coumadin Marevan | |||||||
| Tablet containing warfarin sodium 2 mg | Oral | 50 | 2 | Coumadin | |||||||
| Tablet containing warfarin sodium 3 mg | Oral | 50 | 2 | Marevan | |||||||
| Tablet containing warfarin sodium 5 mg | Oral | 50 | 2 | Coumadin Marevan | |||||||
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | Sachets containing oral powder 100 g, 10 (RenaStart) | Oral | 8 | 5 | RenaStart | |||||||
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | Oral powder 400 g (Kindergen) | Oral | 16 | 5 | Kindergen | |||||||
Ziprasidone | Capsule 20 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox | |||||||
| Capsule 40 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox | |||||||
| Capsule 60 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox | |||||||
| Capsule 80 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox | |||||||
Zoledronic acid | Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL | Injection | 1 | .. | Aclasta | |||||||
Zolmitriptan | Tablet 2.5 mg | Oral | 4 | 5 | Zomig | |||||||
Zuclopenthixol Decanoate | Oily I.M. injection 200 mg in 1 mL ampoule | Injection | 5 | .. | Clopixol Depot | |||||||
SCHEDULE 1 – PART 2 | |||||||||||||||
Listed Drug | Form (strength, type, size, etc.) | Streamlined authority code | Purposes | Manner of adminis- tration | Maximum quantity | Maximum number | Brand | ||||||||
Aciclovir | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 90 | 5 | Aciclovir 200 Acihexal Acyclo-V 200 Chem mart Aciclovir GenRx Aciclovir Lovir Ozvir Terry White Chemists Aciclovir Zovirax 200 mg | ||||||||
|
|
|
|
|
| ||||||||||
|
|
|
|
| |||||||||||
|
|
|
|
| |||||||||||
|
|
|
|
| |||||||||||
|
|
| |||||||||||||
|
|
| |||||||||||||
|
|
| |||||||||||||
|
|
|
|
| |||||||||||
| Tablet 800 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L) | Oral | 120 | 5 | Acihexal Acyclo-V 800 Lovir Zovirax 800 mg | ||||||||
|
|
| |||||||||||||
|
|
| |||||||||||||
|
|
| |||||||||||||
Adalimumab | Injection 40 mg in 0.8 mL pre-filled syringe |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 2 | 3 | Humira | ||||||||
|
|
|
|
|
|
| |||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| ||||||||
|
|
| (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| ||||||||
SCHEDULE 1 – PART 2 — continued | ||||||||||||||||||||||||||||||||||||||||
Listed Drug | Form (strength, type, size, etc.) | Streamlined authority code | Purposes | Manner of adminis- tration | Maximum quantity | Maximum number | Brand | |||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised adalimumab therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis; and | Injection | 2 | 3 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with adalimumab during the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
|
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with adalimumab prior to 16 March 2006; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who is receiving treatment with adalimumab at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Crohn disease In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the current CDAI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the baseline CDAI assessment is from immediately prior to commencing treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient may qualify for PBS-subsidised treatment under this restriction once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the CDAI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the CDAI assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient's assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, or consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the date of clinical assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all assessments are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) has demonstrated or sustained an adequate response to treatment with adalimumab according to the criteria included in the relevant continuation restriction; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient's condition; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the date of clinical assessment(s); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the signed patient acknowledgement; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient's assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the baseline assessment is from immediately prior to commencing treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient may qualify for PBS-subsidised treatment under this restriction once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Chronic plaque psoriasis (whole body) — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: | Injection | 2 | 4 | Humira | |||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (whole body) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 1 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS- |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled syringe |
| Chronic plaque psoriasis (whole body) — initial treatment 3 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of adalimumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with adalimumab prior to 1 March 2009; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (whole body) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 3 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of adalimumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with adalimumab prior to 1 March 2009; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose disease, prior to treatment with adalimumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| to initiation of adalimumab therapy) and the most recent PASI assessment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of adalimumab treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient will be deemed to have failed to respond to treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 2 | 3 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised adalimumab therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 3 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with adalimumab during the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with adalimumab prior to 16 March 2006; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who is receiving treatment with adalimumab at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
|
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Crohn disease In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the current CDAI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the baseline CDAI assessment is from immediately prior to commencing treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient may qualify for PBS-subsidised treatment under this restriction once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the CDAI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the CDAI assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient's assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, or consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has demonstrated or sustained an adequate response to treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the date of clinical assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all assessments are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Crohn disease |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) has demonstrated or sustained an adequate response to treatment with adalimumab according to the criteria included in the relevant continuation restriction; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) improvement of intestinal inflammation as demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) faeces: normalisation of lactoferrin or calprotectin level; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) reversal of high faecal output state; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) avoidance of the need for surgery or total parenteral nutrition (TPN); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient's condition; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the date of clinical assessment(s); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the signed patient acknowledgement; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient's assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the baseline assessment is from immediately prior to commencing treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient may qualify for PBS-subsidised treatment under this restriction once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Chronic plaque psoriasis (whole body) — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: | Injection | 2 | 4 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (whole body) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 1 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre-filled pen |
| Chronic plaque psoriasis (whole body) — initial treatment 3 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of adalimumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who: | Injection | 2 | 5 | Humira | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with adalimumab prior to 1 March 2009; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (whole body) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 3 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of adalimumab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with adalimumab prior to 1 March 2009; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose disease, prior to treatment with adalimumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of adalimumab treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to adalimumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
Adrenaline | I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application | Injection | 2 | .. | EpiPen Jr. | |||||||||||||||||||||||||||||||||
|
|
| Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug |
|
|
|
| |||||||||||||||||||||||||||||||||
| I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application | Injection | 2 | .. | EpiPen | |||||||||||||||||||||||||||||||||
|
|
| Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug |
|
|
|
| |||||||||||||||||||||||||||||||||
Albendazole | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 6 | 1 | Zentel | |||||||||||||||||||||||||||||||||
|
| 1525 | Treatment of tapeworm infestation |
|
|
|
| |||||||||||||||||||||||||||||||||
Amino acids — synthetic, formula | Oral powder 400 g (EleCare) |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where: | Oral | 12 | 5 | EleCare | |||||||||||||||||||||||||||||||||
|
|
| eosinophilic oesophagitis is demonstrated by the following criteria: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the date of birth of the patient is included in the authority application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| treatment with oral steroids is not commenced during the period of initial treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral powder 400 g (EleCare) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | EleCare | |||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate | |||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate Advance) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate Advance | |||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate Advance Tropical Flavour) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate Advance Tropical Flavour | |||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
|
|
|
| |||||||||||||||||||||||||||||||||
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate LCP | |||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
|
|
|
| |||||||||||||||||||||||||||||||||
Amoxycillin | Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of infections suspected or proven to be due to a susceptible organism in patients who require a liquid formulation and in whom the syrup formulations are unsuitable | Oral | 1 | 1 | Amoxil | |||||||||||||||||||||||||||||||||
Anakinra | Injection 100 mg in 0.67 mL single use pre-filled syringe |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with anakinra within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 28 | 5 | Kineret | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with anakinra; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with anakinra; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of anakinra therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised anakinra in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
Atorvastatin | Tablet 10 mg (as calcium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Lipitor | |||||||||||||||||||||||||||||||||
| Tablet 20 mg (as calcium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Lipitor | |||||||||||||||||||||||||||||||||
| Tablet 40 mg (as calcium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Lipitor | |||||||||||||||||||||||||||||||||
| Tablet 80 mg (as calcium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Lipitor | |||||||||||||||||||||||||||||||||
Azithromycin | Tablet 500 mg (as dihydrate) |
| Trachoma | Oral | 2 | 2 | Azithromycin Sandoz Zithromax | |||||||||||||||||||||||||||||||||
Bortezomib | Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of a patient with a histological diagnosis of multiple myeloma who has progressive disease after at least 1 prior therapy, who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily or who has failed to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease ; and | Injection | 4 | 3 | Velcade | |||||||||||||||||||||||||||||||||
|
|
| where progressive disease is defined as at least 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (f) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein and less than 200 mg per 24 hour Bence-Jones proteinuria; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where thalidomide treatment failure is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or Grade 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) less than a 25% reduction in serum or urine M protein; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient is not receiving concomitant PBS-subsidised lenalidomide; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) duration of thalidomide and daily dose prescribed; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| to enable confirmation of eligibility by the Medicare Australia CEO, current diagnostic reports of at least 1 of the following are required: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the level of serum M protein (monoclonal protein); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) the serum level of free kappa and lambda light chains; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) bone marrow aspirate or trephine; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) if present, the size and location of lytic bone lesions (not including compression fractures); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (g) if present, the level of hypercalcaemia, corrected for albumin concentration; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| as these parameters will be used to determine response, results of the above diagnostic reports must be provided with the authority application as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) for all patients, results for (a) or (b) or (c) must be provided; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) where the patient has oligo-secretory or non-secretory multiple myeloma, (c) or (d) or if relevant (e), (f) or (g) must be provided; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (either previous or current serum M protein less than 10 g per L and urinary Bence-Jones protein undetectable or less than 200 mg per 24 hours) must be provided |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) at least a 50% reduction in bone marrow plasma cells; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (f) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (g) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a response assessment is not submitted to the Medicare Australia CEO prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application is made not later than 6 months after the application for initial treatment and includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS-subsidised treatment with bortezomib; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved |
|
|
|
| |||||||||||||||||||||||||||||||||
Bromocriptine | Tablet 2.5 mg (as mesylate) |
| Acromegaly Parkinson's disease Pathological hyperprolactinaemia where surgery is not indicated Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution Pathological hyperprolactinaemia where radiotherapy is not indicated Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | Oral | 60 | 5 | Kripton 2.5 Parlodel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
Buprenorphine | Transdermal patch 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Completion of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program | Oral | 90 | .. | Clorprax Prexaton Zyban | |||||||||||||||||||||||||||||||||
Cabergoline | Tablet 500 micrograms |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 8 | 5 | Dostinex Tinexa | |||||||||||||||||||||||||||||||||
|
| 2659 | Pathological hyperprolactinaemia where surgery is not indicated |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2660 | Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2661 | Pathological hyperprolactinaemia where radiotherapy is not indicated |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2662 | Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution |
|
|
|
| |||||||||||||||||||||||||||||||||
Carbomer | Eye gel 2 mg per g, |
| For use in patients who have severe dry eye syndrome, including Sjogren’s syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | GelTears PAA Viscotears | |||||||||||||||||||||||||||||||||
Carmellose | Eye drops containing carmellose sodium 5 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Refresh Tears Plus | |||||||||||||||||||||||||||||||||
| Eye drops containing carmellose sodium 10 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Refresh Liquigel | |||||||||||||||||||||||||||||||||
Carmellose with glycerin | Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 7 | Optive | |||||||||||||||||||||||||||||||||
Ceftriaxone | Powder for injection 500 mg (as sodium) |
| Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven | Injection | 5 | .. | Ceftriaxone ICP | |||||||||||||||||||||||||||||||||
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | |||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 100 mg in 50 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | |||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 500 mg in 100 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | |||||||||||||||||||||||||||||||||
Cholestyramine | Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50 |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 2 | 11 | Questran Lite | |||||||||||||||||||||||||||||||||
Ciprofloxacin | Tablet 250 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients | Oral | 14 | .. | C-Flox 250 Cifran Ciprol 250 Ciproxin 250 GenRx Ciprofloxacin Profloxin | |||||||||||||||||||||||||||||||||
|
|
| Bacterial gastroenteritis in severely immunocompromised patients |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials |
|
|
|
| |||||||||||||||||||||||||||||||||
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment (for up to 6 months) of severe disabling pain not responding to non-narcotic analgesics, at a dose not exceeding 8 tablets per day | Oral | 60 | .. | APO-Paracetamol/ Codalgin Forte Codapane Forte Comfarol Forte Dolaforte Panadeine Forte Prodeine Forte | |||||||||||||||||||||||||||||||||
Colestipol | Oral powder, sachets containing colestipol hydrochloride 5 g, 120 |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 1 | 11 | Colestid | |||||||||||||||||||||||||||||||||
Copper sulfate | Tablets, diagnostic compound, 36 |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 6 | Clinitest | |||||||||||||||||||||||||||||||||
Cyproterone | Tablet containing cyproterone acetate 50 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 100 | 5 | Androcur Cyprohexal | |||||||||||||||||||||||||||||||||
|
| 1014 1404 | Advanced carcinoma of the prostate To reduce drive in sexual deviations in males |
|
|
| Cyprone Cyprostat GenRx Cyproterone Acetate Procur | |||||||||||||||||||||||||||||||||
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | |||||||||||||||||||||||||||||||||
| Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | |||||||||||||||||||||||||||||||||
| Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | |||||||||||||||||||||||||||||||||
Dasatinib | Tablet 20 mg |
| Chronic myeloid leukaemia | Oral | 60 | 2 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) details of Grade 3 or 4 non-haematological imatinib related toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 20 mg |
| Chronic myeloid leukaemia | Oral | 60 | 5 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with dasatinib is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 50 mg |
| Chronic myeloid leukaemia | Oral | 60 | 2 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) details of Grade 3 or 4 non-haematological imatinib related toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 50 mg |
| Chronic myeloid leukaemia | Oral | 60 | 5 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with dasatinib is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 70 mg |
| Chronic myeloid leukaemia | Oral | 60 | 2 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) details of Grade 3 or 4 non-haematological imatinib related toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 70 mg |
| Chronic myeloid leukaemia | Oral | 60 | 5 | Sprycel | |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with dasatinib is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
Desmopressin | Tablet containing desmopressin acetate 200 micrograms |
1678 | In compliance with authority procedures set out in subparagraph 11 (d): Cranial diabetes insipidus | Oral | 90 | 5 | Minirin | |||||||||||||||||||||||||||||||||
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL |
1678 | In compliance with authority procedures set out in subparagraph 11 (d): Cranial diabetes insipidus | Nasal | 2 | 5 | Minirin Nasal Spray | |||||||||||||||||||||||||||||||||
Diazepam | Tablet 2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity Malignant neoplasia (late stage) | Oral | 100 | .. | Antenex 2 Valium Valpam 2 | |||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity Malignant neoplasia (late stage) For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Oral | 100 | .. | Antenex 5 Diazepam-DP Diazepam-GA Ranzepam Valium Valpam 5 | |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
Docetaxel | Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide Advanced breast cancer after failure of prior therapy which includes an anthracycline Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | Injection | 2 | .. | Taxotere | |||||||||||||||||||||||||||||||||
|
|
| Locally advanced or metastatic non-small cell lung cancer |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of HER2 positive early breast cancer in combination with trastuzumab |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles |
|
|
|
| |||||||||||||||||||||||||||||||||
Doxycycline | Tablet 100 mg (as monohydrate) |
| Pelvic inflammatory disease | Oral | 28 | .. | Chem mart Doxycycline | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxyhexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| GenRx Doxycycline | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Doxycycline | |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as monohydrate) |
| Urethritis | Oral | 21 | .. | Chem mart Doxycycline | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxyhexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| GenRx Doxycycline | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Doxycycline | |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Pelvic inflammatory disease | Oral | 28 | .. | Doxsig | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxy-100 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxylin 100 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Vibramycin | |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Urethritis | Oral | 21 | .. | Doxsig | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxy-100 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Doxylin 100 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Vibramycin | |||||||||||||||||||||||||||||||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) |
| Pelvic inflammatory disease | Oral | 28 | .. | DBL Doxycycline Doryx | |||||||||||||||||||||||||||||||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) |
| Urethritis | Oral | 21 | .. | DBL Doxycycline Doryx | |||||||||||||||||||||||||||||||||
Enoxaparin | Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | |||||||||||||||||||||||||||||||||
| Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | |||||||||||||||||||||||||||||||||
| Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL |
| Haemodialysis | Injection | 20 | 3 | Clexane | |||||||||||||||||||||||||||||||||
| Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | |||||||||||||||||||||||||||||||||
Eprosartan | Tablet 400 mg (as mesylate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 56 | 5 | Teveten | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
Escitalopram | Tablet 10 mg (as oxalate) |
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared | Oral | 28 | 5 | Esipram Lexapro | |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 March 2008 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 March 2008 |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 20 mg (as oxalate) |
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared | Oral | 28 | 5 | Esipram Lexapro | |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 March 2008 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 March 2008 |
|
|
|
| |||||||||||||||||||||||||||||||||
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) |
| Maintenance of healed gastro-oesophageal reflux disease | Oral | 30 | 5 | Nexium | |||||||||||||||||||||||||||||||||
Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
7 |
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and | Injection | 2 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 2 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 2 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documente d history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL |
| Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: | Injection | 2 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injections 50 mg |
| Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1 mL single use auto-injector, 4 |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Ankylosing spondylitis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Ankylosing spondylitis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Psoriatic arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Psoriatic arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 1 | 3 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Rheumatoid arthritis In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Rheumatoid arthritis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection 50 mg in 1mL single use auto-injector, 4 |
| Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: | Injection | 1 | 5 | Enbrel | |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — continuing treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
Famciclovir | Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Oral | 21 | .. | Famvir | |||||||||||||||||||||||||||||||||
| Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 56 | 5 | Famvir | |||||||||||||||||||||||||||||||||
| Tablet 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 56 | 5 | Famvir | |||||||||||||||||||||||||||||||||
|
|
| Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| |||||||||||||||||||||||||||||||||
Fenofibrate | Tablet 48 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 60 | 11 | Lipidil | |||||||||||||||||||||||||||||||||
| Tablet 145 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Lipidil | |||||||||||||||||||||||||||||||||
Fentanyl | Transdermal patch 2.1 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 12 | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 4.2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 25 | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 8.4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 50 | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 12.6 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 75 | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Transdermal patch 16.8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 100 | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Fluvastatin | Capsule 20 mg (as sodium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 28 | 11 | Lescol Vastin | |||||||||||||||||||||||||||||||||
| Capsule 40 mg (as sodium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 28 | 11 | Lescol Vastin | |||||||||||||||||||||||||||||||||
| Tablet (prolonged release) 80 mg (as sodium) |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 28 | 11 | Lescol XL | |||||||||||||||||||||||||||||||||
Gemfibrozil | Tablet 600 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 60 | 11 | Ausgem Chem mart Gemfibrozil Gemhexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| GenRx Gemfibrozil | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Jezil | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Lipazil 600 mg | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Lopid | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Pharmacor Gemfibrozil 600 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Gemfibrozil | |||||||||||||||||||||||||||||||||
Glucose and Ketone Indicator—Urine | Test strips, 50 (Keto-Diabur-Test 5000) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 4 | Keto-Diabur-Test 5000 | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Keto-Diastix) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 4 | Keto-Diastix | |||||||||||||||||||||||||||||||||
Glucose Indicator—Blood | Test strips, 25 (On-Call Plus) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 4 | 11 | On-Call Plus | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Accu-Chek Active) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Accu-Chek Active | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Accu-Chek Go) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Accu-Chek Go | |||||||||||||||||||||||||||||||||
| Test strips, 51 (Accu-Chek Integra) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Accu-Chek Integra | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Accu-Chek Mobile) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Accu-Chek Mobile | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Advantage II) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Advantage II | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Betachek) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Betachek | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Betachek G5) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Betachek G5 | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Bionime Rightest) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Bionime Rightest | |||||||||||||||||||||||||||||||||
| Test strips, 50 (CareSens) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | CareSens | |||||||||||||||||||||||||||||||||
| Test strips, 50 (FreeStyle) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | FreeStyle | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Freestyle Papillon) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Freestyle Papillon | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Glucocard 01 Sensor) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Glucocard 01 Sensor | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Glucoflex-R) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Glucoflex-R | |||||||||||||||||||||||||||||||||
| Test strips, 50 (GlucoOz) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | GlucoOz | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Glucostix) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Glucostix | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Lifeline Attest) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Lifeline Attest | |||||||||||||||||||||||||||||||||
| Test strips, 50 (MWD Pen Sensor Strips) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | MWD Pen Sensor Strips | |||||||||||||||||||||||||||||||||
| Test strips, 50 (MyGlucoHealth) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | MyGlucoHealth | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Omnitest EZ) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Omnitest EZ | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Omnitest Plus) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Omnitest Plus | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Optium Omega) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | Optium Omega | |||||||||||||||||||||||||||||||||
| Test strips, 50 (SensoCard) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | SensoCard | |||||||||||||||||||||||||||||||||
| Test strips, 50 (TrueTrack) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 11 | TrueTrack | |||||||||||||||||||||||||||||||||
| Test strips, 100 (Accu-Chek Performa) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 1 | 11 | Accu-Chek Performa | |||||||||||||||||||||||||||||||||
| Test strips, 100 (FreeStyle Lite) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 1 | 11 | FreeStyle Lite | |||||||||||||||||||||||||||||||||
| Test strips, 100 (Optium glucose) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 1 | 11 | Optium glucose | |||||||||||||||||||||||||||||||||
| Test strips, 100 (SofTact) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 1 | 11 | SofTact | |||||||||||||||||||||||||||||||||
Glucose Indicator—Urine | Test strips, 50 (Clinistix) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 4 | Clinistix | |||||||||||||||||||||||||||||||||
| Test strips, 50 (Diastix) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | For external use | 2 | 4 | Diastix | |||||||||||||||||||||||||||||||||
Granisetron | Tablet 2 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 5 | 1 | Kytril | |||||||||||||||||||||||||||||||||
| Concentrated injection 3 mg (as hydrochloride) in 3 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Kytril | |||||||||||||||||||||||||||||||||
Hydrocortisone | Injection 100 mg (as sodium succinate) with 2 mL solvent |
| For use in a hospital | Injection | 6 | .. | Solu-Cortef | |||||||||||||||||||||||||||||||||
| Injection 250 mg (as sodium succinate) with 2 mL solvent |
| For use in a hospital | Injection | 6 | .. | Solu-Cortef | |||||||||||||||||||||||||||||||||
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing hydromorphone hydrochloride 4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing hydromorphone hydrochloride 8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet (modified release) containing hydromorphone hydrochloride 4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 20 | .. | Jurnista | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet (modified release) containing hydromorphone hydrochloride 8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | Jurnista | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet (modified release) containing hydromorphone hydrochloride 16 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | Jurnista | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet (modified release) containing hydromorphone hydrochloride 32 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | Jurnista | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet (modified release) containing hydromorphone hydrochloride 64 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | Jurnista | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | Dilaudid | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Hypromellose | Eye drops 3 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Genteal In a Wink Moisturising | |||||||||||||||||||||||||||||||||
| Eye drops 5 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Methopt | |||||||||||||||||||||||||||||||||
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2 mg per g, 10 g |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Genteal gel HPMC PAA | |||||||||||||||||||||||||||||||||
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Poly-Tears Tears Naturale | |||||||||||||||||||||||||||||||||
Ibuprofen | Tablet 400 mg |
| Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease | Oral | 90 | 3 | Brufen | |||||||||||||||||||||||||||||||||
Imatinib | Tablet 100 mg (as mesylate) |
| Chronic myeloid leukaemia (chronic phase) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 60 | 5 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient is not receiving concomitant PBS-subsidised interferon alfa therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (chronic phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr-abl level in the blood in the preceding 12 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a peripheral blood bcr-abl level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with imatinib mesylate is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr-abl specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of bcr-abl transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr-abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr-abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr-abl specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Chronic myeloid leukaemia (accelerated phase) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where progress to the accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) peripheral basophils greater than or equal to 20%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (blast phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where progress to myeloid blast crisis is defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) extramedullary involvement other than spleen and liver; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (accelerated phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (blast phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Acute lymphoblastic leukaemia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL; and | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Acute lymphoblastic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript BCR-ABL who was previously treated with imatinib mesylate under the Imatinib Compassionate Program and who meets all the PBS criteria; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Acute lymphoblastic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| imatinib mesylate is available with a lifetime maximum of 24 months for continuing treatment with imatinib mesylate therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Dermatofibrosarcoma protuberans In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans, and where: | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) if the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim is provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence is specified; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) if the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease are provided |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Dermatofibrosarcoma protuberans |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans who has previously been issued with an authority prescription for imatinib and who has demonstrated a response, but whose disease remains unresectable, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Hypereosinophilic syndrome or chronic eosinophilic leukaemia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia requiring treatment and confirmed to carry the FIP1L1-PDGFRA fusion gene, and where the application for authorisation includes: | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Hypereosinophilic syndrome or chronic eosinophilic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia who has previously been issued with an authority prescription for imatinib and who has achieved and maintained a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Myelodysplastic or myeloproliferative disorder In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a myelodysplastic or myeloproliferative disorder where: | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) there is confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement either by standard karyotyping, or FISH, or PDGFRB fusion gene transcript; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — cytarabine; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — etoposide; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — hydroxyurea; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the bone marrow biopsy report which demonstrates the presence of a myelodysplastic or myeloproliferative disorder; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of the prior therapy trialled and the response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Myelodysplastic or myeloproliferative disorder |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| Systemic mastocytosis with eosinophilia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis with eosinophilia where: | Oral | 60 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) there is confirmed evidence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — corticosteroids; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — hydroxyurea; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a copy of the full blood examination report demonstrating eosinophilia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of symptomatic organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) details of prior treatment trialled and the response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (f) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Systemic mastocytosis with eosinophilia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Chronic myeloid leukaemia (chronic phase) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 30 | 5 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the patient is not receiving concomitant PBS-subsidised interferon alfa therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (chronic phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr-abl level in the blood in the preceding 12 months; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a peripheral blood bcr-abl level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with imatinib mesylate is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr-abl specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of bcr-abl transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr-abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr-abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr-abl specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Chronic myeloid leukaemia (accelerated phase) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where progress to the accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) peripheral basophils greater than or equal to 20%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (blast phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where progress to myeloid blast crisis is defined as either: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) extramedullary involvement other than spleen and liver; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (accelerated phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic myeloid leukaemia (blast phase) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Acute lymphoblastic leukaemia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL; and | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Acute lymphoblastic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript BCR-ABL who was previously treated with imatinib mesylate under the Imatinib Compassionate Program and who meets all the PBS criteria; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Acute lymphoblastic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| imatinib mesylate is available with a lifetime maximum of 24 months for continuing treatment with imatinib mesylate therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Dermatofibrosarcoma protuberans In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans, and where: | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) if the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim is provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence is specified; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (4) if the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease are provided |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Dermatofibrosarcoma protuberans |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 800 mg per day) of a patient with unresectable, locally recurrent or metastatic dermatofibrosarcoma protuberans who has previously been issued with an authority prescription for imatinib and who has demonstrated a response, but whose disease remains unresectable, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Hypereosinophilic syndrome or chronic eosinophilic leukaemia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia requiring treatment and confirmed to carry the FIP1L1-PDGFRA fusion gene, and where the application for authorisation includes: | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Hypereosinophilic syndrome or chronic eosinophilic leukaemia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with hypereosinophilic syndrome or chronic eosinophilic leukaemia who has previously been issued with an authority prescription for imatinib and who has achieved and maintained a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Myelodysplastic or myeloproliferative disorder In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a myelodysplastic or myeloproliferative disorder where: | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) there is confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement either by standard karyotyping, or FISH, or PDGFRB fusion gene transcript; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — cytarabine; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — etoposide; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — hydroxyurea; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the bone marrow biopsy report which demonstrates the presence of a myelodysplastic or myeloproliferative disorder; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of the prior therapy trialled and the response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Myelodysplastic or myeloproliferative disorder |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| Systemic mastocytosis with eosinophilia In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis with eosinophilia where: | Oral | 30 | 2 | Glivec | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| (1) there is confirmed evidence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) the patient has previously failed an adequate trial of 1 or more of the following conventional therapies: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — corticosteroids; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| — hydroxyurea; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a copy of the bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a copy of the full blood examination report demonstrating eosinophilia; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) details of symptomatic organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (e) details of prior treatment trialled and the response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (f) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Systemic mastocytosis with eosinophilia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the full blood examination report which demonstrates a complete haematological response; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) a statement that the disease has not progressed on imatinib therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
Interferon Alfa-2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Injection | 15 | 5 | Roferon-A | |||||||||||||||||||||||||||||||||
| Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Injection | 5 | 5 | Roferon-A | |||||||||||||||||||||||||||||||||
| Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Injection | 5 | 5 | Roferon-A | |||||||||||||||||||||||||||||||||
| Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Injection | 5 | 5 | Roferon-A | |||||||||||||||||||||||||||||||||
Interferon Alfa-2b | Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen |
| In compliance with authority procedures set out in subparagraph 11 (d): Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | Injection | 3 | 5 | Intron A Redipen | |||||||||||||||||||||||||||||||||
Ketoconazole | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Oral candidiasis in severely immunocompromised persons where topical therapy has failed Systemic or deep mycoses where other forms of therapy have failed | Oral | 30 | 5 | Nizoral | |||||||||||||||||||||||||||||||||
Lansoprazole | Tablet 30 mg (orally disintegrating) |
| Gastro-oesophageal reflux disease Scleroderma oesophagus | Oral | 28 | 5 | Zoton FasTabs | |||||||||||||||||||||||||||||||||
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 30 | 5 | Zanidip | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing lercanidipine hydrochloride 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 30 | 5 | Zanidip | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
Levetiracetam | Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 1 g |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| |||||||||||||||||||||||||||||||||
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg |
| Endometriosis | Oral | 100 | 2 | Provera Ralovera | |||||||||||||||||||||||||||||||||
Methadone | Tablet containing methadone hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Physeptone | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Injection containing methadone hydrochloride 10 mg in 1 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Injection | 10 | .. | Physeptone | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Methotrexate | Tablet 10 mg |
| For patients requiring doses greater than 20 mg per week | Oral | 50 | 2 | Methoblastin | |||||||||||||||||||||||||||||||||
Metronidazole | Tablet 400 mg |
| Treatment of anaerobic infections | Oral | 21 | 1 | Flagyl Metrogyl 400 Metronide 400 | |||||||||||||||||||||||||||||||||
Milk powder — lactose free formula | Oral powder 900 g (S-26 LF) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 5 | 5 | S-26 LF | |||||||||||||||||||||||||||||||||
|
|
| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) hydrogen breath test |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral powder 900 g (Karicare De-Lact) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 5 | 5 | Karicare De-Lact | |||||||||||||||||||||||||||||||||
|
|
| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) hydrogen breath test |
|
|
|
| |||||||||||||||||||||||||||||||||
Milk powder — lactose modified | Oral powder 900 g (Digestelact) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 3 | 10 | Digestelact | |||||||||||||||||||||||||||||||||
|
|
| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) hydrogen breath test |
|
|
|
| |||||||||||||||||||||||||||||||||
Morphine | Tablet containing morphine sulfate 30 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Anamorph | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 5 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 10 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Momex SR 10 MS Contin
| |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 15 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 30 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Momex SR 30 MS Contin
| |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 60 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Momex SR 60 MS Contin
| |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 100 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Momex SR 100 MS Contin
| |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 30 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 60 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 90 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 40 | .. | Kapanol | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 120 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 40 | .. | MS Contin Suspension 20 mg | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 40 | .. | MS Contin Suspension 30 mg | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 40 | .. | MS Contin Suspension 60 mg | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 40 | .. | MS Contin Suspension 100 mg | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 2 | .. | Ordine 2 | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 2 | .. | Ordine 5 | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 2 | .. | Ordine 10 | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Naratriptan | Tablet 2.5 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS-listed drugs | Oral | 4 | 5 | Naramig | |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS-listed drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS-listed drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences |
|
|
|
| |||||||||||||||||||||||||||||||||
Nifedipine | Tablet 20 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 30 | 5 | Adalat Oros 20mg | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
Nilotinib | Capsule 200 mg (as hydrochloride monohydrate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with nilotinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to nilotinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and | Oral | 112 | 5 | Tasigna | |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| response to PBS-subsidised treatment with nilotinib is assessed by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 18 months of the commencement of treatment with nilotinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS-subsidised treatment with nilotinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
Nitrazepam | Tablet 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Myoclonic epilepsy | Oral | 50 | 5 | Alodorm Mogadon | |||||||||||||||||||||||||||||||||
|
|
| Malignant neoplasia (late stage) |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
Omeprazole | Tablet 20 mg (as magnesium) |
| Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome | Oral | 30 | 5 | Acimax Tablets Losec Tablets Omepral | |||||||||||||||||||||||||||||||||
| Tablet 20 mg |
| Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome | Oral | 30 | 5 | APO-Omeprazole Chem mart Omeprazole GenRx Omeprazole | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Meprazol | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Omeprazole-GA | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Omeprazole Ranbaxy | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Omeprazole Winthrop | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Omeprazole Ozmep | |||||||||||||||||||||||||||||||||
| Capsule 20 mg |
| Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome | Oral | 30 | 5 | Probitor | |||||||||||||||||||||||||||||||||
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | APO-Ondansetron Ondansetron-RL Ondaz Onsetron 4 Zofran | |||||||||||||||||||||||||||||||||
| Tablet 8 mg (as hydrochloride dihydrate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | APO-Ondansetron Ondansetron-RL Ondaz Onsetron 8 Zofran | |||||||||||||||||||||||||||||||||
| Wafer 4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |||||||||||||||||||||||||||||||||
| Wafer 8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron-RL Zydis Ondaz Zydis Zofran Zydis | |||||||||||||||||||||||||||||||||
| Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 1 | 1 | Zofran syrup | |||||||||||||||||||||||||||||||||
| I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Ondansetron-RL Ondaz Onsetron Pfizer Australia Pty Ltd Zofran | |||||||||||||||||||||||||||||||||
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Ondansetron-RL Ondaz Onsetron Pfizer Australia Pty Ltd Zofran | |||||||||||||||||||||||||||||||||
Oxazepam | Tablet 15 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | Alepam 15 Serepax | |||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 30 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | Alepam 30 Murelax Serepax | |||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Endone | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months | Oral | 2 | .. | OxyNorm Liquid 5mg/5mL | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 15 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 30 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
| Suppository 30 mg (as pectinate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Rectal | 24 | .. | Proladone | |||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics |
|
|
|
| |||||||||||||||||||||||||||||||||
Pancreatic Extract | Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity |
| For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 500 | 21 | Creon 5000 | |||||||||||||||||||||||||||||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity |
| For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 500 | 21 | Creon 10,000 | |||||||||||||||||||||||||||||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity |
| For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 200 | 21 | Creon 25,000 | |||||||||||||||||||||||||||||||||
| Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity |
| For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 200 | 21 | Creon 40,000 | |||||||||||||||||||||||||||||||||
Pancrelipase | Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity |
| For use in patients with cystic fibrosis, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 200 | 21 | Panzytrat 25000 | |||||||||||||||||||||||||||||||||
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) |
| Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome | Oral | 30 | 5 | Somac | |||||||||||||||||||||||||||||||||
| Sachet containing granules 40 mg (as sodium sesquihydrate) |
| Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome | Oral | 30 | 5 | Somac | |||||||||||||||||||||||||||||||||
Paracetamol | Tablet 500 mg |
| Chronic arthropathies | Oral | 300 | 4 | APO-Paracetamol Chem mart Paracetamol | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Dymadon P | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Febridol | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Generic Health Pty Ltd | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Panamax | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Paracetamol Sandoz | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Paralgin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Pharmacy Choice Paracetamol | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Paracetamol | |||||||||||||||||||||||||||||||||
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 2 | 11 | Duratears Poly Visc | |||||||||||||||||||||||||||||||||
| Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Ircal Lacri-Lube Poly Visc | |||||||||||||||||||||||||||||||||
Phenoxymethyl-penicillin | Tablet 250 mg phenoxymethyl-penicillin (as potassium) |
| Prophylaxis of recurrent streptococcal infections (including rheumatic fever) | Oral | 50 | 5 | Abbocillin-VK Filmtab | |||||||||||||||||||||||||||||||||
| Capsule 250 mg phenoxymethyl-penicillin (as potassium) |
| Prophylaxis of recurrent streptococcal infections (including rheumatic fever) | Oral | 50 | 5 | Cilicaine VK Cilopen VK LPV | |||||||||||||||||||||||||||||||||
Polyethylene glycol 400 | Eye drops 2.5 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Blink Intensive Tears | |||||||||||||||||||||||||||||||||
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg-3 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Systane | |||||||||||||||||||||||||||||||||
Poly-l-lactic acid | Powder for injection 150 mg |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection; | Injection | 2 | 4 | Sculptra | |||||||||||||||||||||||||||||||||
|
|
| accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients must be referred from the HIV physician to the accredited injector |
|
|
|
| |||||||||||||||||||||||||||||||||
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Liquifilm Tears PVA Tears | |||||||||||||||||||||||||||||||||
| Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Vistil | |||||||||||||||||||||||||||||||||
| Eye drops 30 mg per mL, 15 mL |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Liquifilm Forte PVA Forte | |||||||||||||||||||||||||||||||||
| Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Application to the eye | 1 | 11 | Vistil Forte | |||||||||||||||||||||||||||||||||
Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms |
| Treatment of severe primary restless legs syndrome in a patient who manifests all 4 diagnostic criteria listed below and whose baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score is greater than or equal to 21 points prior to initiation of pramipexole, where the date and IRLSRS score are documented in the patient's medical records at the time pramipexole treatment is initiated, and where the diagnostic criteria for restless legs syndrome are: | Oral | 30 | 2 | Sifrol | |||||||||||||||||||||||||||||||||
|
|
| (a) an urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet containing pramipexole hydrochloride 250 micrograms |
| Parkinson disease | Oral | 100 | 5 | Sifrol | |||||||||||||||||||||||||||||||||
Pravastatin | Tablet containing pravastatin sodium 10 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Pravastatin Chem mart Pravastatin Cholstat 10 GenRx Pravastatin Lipostat 10 Liprachol Pravachol Pravastatin 10 Pravastatin-GA 10 Pravastatin generichealth Pravastatin Winthrop Terry White Chemists Pravastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
| Tablet containing pravastatin sodium 20 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Pravastatin Chem mart Pravastatin Cholstat 20 GenRx Pravastatin Lipostat 20 Liprachol Pravachol Pravastatin 20 Pravastatin-GA 20 Pravastatin generichealth Pravastatin Winthrop Terry White Chemists Pravastatin Vastoran | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
| Tablet containing pravastatin sodium 40 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Pravastatin Chem mart Pravastatin Cholstat 40 GenRx Pravastatin Lipostat 40 Liprachol Pravachol Pravastatin 40 Pravastatin-GA 40 Pravastatin generichealth Pravastatin Winthrop Terry White Chemists Pravastatin Vastoran | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
| Tablet containing pravastatin sodium 80 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Pravastatin Chem mart Pravastatin Lipostat 80 Pravachol Pravastatin-GA 80 Pravastatin generichealth Pravastatin Sandoz Terry White Chemists Pravastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) |
| Gastro-oesophageal reflux disease Scleroderma oesophagus | Oral | 30 | 5 | Pariet | |||||||||||||||||||||||||||||||||
Ranitidine | Tablet, effervescent, 150 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 60 | 5 | Zantac | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
| Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs | Oral | 2 | 5 | Zantac Syrup | |||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base-priced drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
Rifampicin | Capsule 150 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Leprosy in adults | Oral | 100 | .. | Rimycin 150 | |||||||||||||||||||||||||||||||||
| Capsule 300 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Leprosy in adults | Oral | 100 | .. | Rimycin 300 | |||||||||||||||||||||||||||||||||
Risperidone | Tablet 0.5 mg |
1589 | In compliance with authority procedures set out in subparagraph 11 (d): Schizophrenia | Oral | 60 | 5 | APO-Risperidone Ozidal Resdone 0.5 Rispa Risperdal Risperidone-GA Rixadone | |||||||||||||||||||||||||||||||||
|
| |||||||||||||||||||||||||||||||||||||||
|
| |||||||||||||||||||||||||||||||||||||||
|
| |||||||||||||||||||||||||||||||||||||||
|
|
| ||||||||||||||||||||||||||||||||||||||
| Tablet 0.5 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | |||||||||||||||||||||||||||||||||
|
| 1589 | Schizophrenia |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 1 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 60 | 5 | APO-Risperidone | |||||||||||||||||||||||||||||||||
|
| 1589 2272 | Schizophrenia Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
|
|
| Ozidal Resdone 1 Rispa Risperdal Risperidone-GA Risperidone generichealth Rixadone | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
| Tablet 1 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | |||||||||||||||||||||||||||||||||
|
| 1589 | Schizophrenia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
|
|
|
| |||||||||||||||||||||||||||||||||
| Tablet 2 mg |
1589 2272 | In compliance with authority procedures set out in subparagraph 11 (d): Schizophrenia Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder | Oral | 60 | 5 | APO-Risperidone Ozidal Resdone 2 Rispa Risperdal Risperidone-GA Risperidone generichealth Rixadone | |||||||||||||||||||||||||||||||||
| Tablet 2 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | |||||||||||||||||||||||||||||||||
|
| 1589 | Schizophrenia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
|
|
|
| |||||||||||||||||||||||||||||||||
| Oral solution 1 mg per mL, 100 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 1 | 5 | Risperdal | |||||||||||||||||||||||||||||||||
|
| 1589 | Schizophrenia |
|
|
|
| |||||||||||||||||||||||||||||||||
|
| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
|
|
|
| |||||||||||||||||||||||||||||||||
Rituximab | Solution for I.V. infusion 100 mg in 10 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy | Injection | 2 | 7 | Mabthera | |||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 500 mg in 50 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy | Injection | 1 | 7 | Mabthera | |||||||||||||||||||||||||||||||||
Rivaroxaban | Tablet 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Prevention of venous thromboembolism in a patient undergoing total hip replacement | Oral | 10 | 1 | Xarelto | |||||||||||||||||||||||||||||||||
| Tablet 10 mg, 15 |
| In compliance with authority procedures set out in subparagraph 11 (d): Prevention of venous thromboembolism in a patient undergoing total hip replacement | Oral | 1 | 1 | Xarelto | |||||||||||||||||||||||||||||||||
Sertraline | Tablet 50 mg (as hydrochloride) |
| Obsessive-compulsive disorder Panic disorder where other treatments have failed or are inappropriate | Oral | 30 | 5 | Eleva 50 Xydep 50 Zoloft | |||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Obsessive-compulsive disorder Panic disorder where other treatments have failed or are inappropriate | Oral | 30 | 5 | Eleva 100 Xydep 100 Zoloft | |||||||||||||||||||||||||||||||||
Simvastatin | Tablet 5 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | Simvabell Simvahexal Simvasyn Zimstat Zocor | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
| Tablet 10 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Simvastatin Chem mart Simvastatin GenRx Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Lipex 10 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Ransim | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvabell | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvahexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvar 10 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-DP Simvastatin-GA 10 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin generichealth | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-Spirit 10 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin Winthrop | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvasyn | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zimstat | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zocor | |||||||||||||||||||||||||||||||||
| Tablet 20 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Simvastatin Chem mart Simvastatin GenRx Simvastatin Lipex 20 Ransim Simvabell Simvahexal Simvar 20 Simvastatin-DP | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-GA 20 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin generichealth | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-Spirit 20 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin Winthrop | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvasyn | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zimstat | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zocor | |||||||||||||||||||||||||||||||||
| Tablet 40 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Simvastatin Chem mart Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| GenRx Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Lipex 40 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Ransim | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvabell | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvahexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvar 40 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-DP | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-GA 40 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin generichealth | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-Spirit 40 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin Winthrop | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvasyn | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zimstat | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zocor | |||||||||||||||||||||||||||||||||
| Tablet 80 mg |
| For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 30 | 11 | APO-Simvastatin Chem mart Simvastatin GenRx Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Lipex 80 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Ransim | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvabell | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvahexal | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvar 80 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-DP | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-GA 80 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin generichealth | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin-Spirit 80 | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvastatin Winthrop | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Simvasyn | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Terry White Chemists Simvastatin | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zimstat | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zocor | |||||||||||||||||||||||||||||||||
Sulfasalazine | Tablet 500 mg |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 200 | 11 | Salazopyrin | |||||||||||||||||||||||||||||||||
| Tablet 500 mg (enteric coated) |
| For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | Oral | 200 | 11 | Pyralin EN Salazopyrin-EN | |||||||||||||||||||||||||||||||||
Sunitinib | Capsule 12.5 mg (as malate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009 | Oral | 28 | 3 | Sutent | |||||||||||||||||||||||||||||||||
| Capsule 12.5 mg (as malate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes: | Oral | 28 | 1 | Sutent | |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 25 mg (as malate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009 | Oral | 28 | 3 | Sutent | |||||||||||||||||||||||||||||||||
| Capsule 25 mg (as malate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes: | Oral | 28 | 1 | Sutent | |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 50 mg (as malate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria | Oral | 28 | 3 | Sutent | |||||||||||||||||||||||||||||||||
|
|
| Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009 |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 50 mg (as malate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes: | Oral | 28 | 1 | Sutent | |||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (2) a signed patient acknowledgement |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib |
|
|
|
| |||||||||||||||||||||||||||||||||
Temazepam | Tablet 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | APO-Temazepam Normison Temaze Temtabs | |||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| |||||||||||||||||||||||||||||||||
Temozolomide | Capsule 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | |||||||||||||||||||||||||||||||||
|
|
| Recurrence of glioblastoma multiforme following standard therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Glioblastoma multiforme following radiotherapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | |||||||||||||||||||||||||||||||||
|
|
| Recurrence of glioblastoma multiforme following standard therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Glioblastoma multiforme following radiotherapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 100 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | |||||||||||||||||||||||||||||||||
|
|
| Recurrence of glioblastoma multiforme following standard therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Glioblastoma multiforme following radiotherapy |
|
|
|
| |||||||||||||||||||||||||||||||||
| Capsule 140 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | |||||||||||||||||||||||||||||||||
|
|
| Recurrence of glioblastoma multiforme following standard therapy |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Glioblastoma multiforme following radiotherapy |
|
|
|
| |||||||||||||||||||||||||||||||||
Terbinafine | Tablet 250 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application | Oral | 42 | 1 | GenRx Terbinafine Lamisil (Novartis Pharmaceuticals Australia Pty Limited) Sebifin 250 Tamsil Terbihexal Terbinafine 250 Terbinafine-DP Zabel | |||||||||||||||||||||||||||||||||
Tramadol | Capsule containing tramadol hydrochloride 50 mg |
| For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed | Oral | 20 | 2 | Chem mart Tramadol GenRx Tramadol Lodam 50 Terry White Chemists Tramadol Tramal Tramedo | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
| Zydol | |||||||||||||||||||||||||||||||||
| Tablet (sustained release) containing tramadol hydrochloride 50 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 40 | .. | Tramal SR 50 | |||||||||||||||||||||||||||||||||
| Tablet (sustained release) containing tramadol hydrochloride 100 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 40 | .. | APO-Tramadol SR Chem mart Tramadol SR Lodam SR 100 Terry White Chemists Tramadol SR Tramahexal SR Tramal SR 100 Tramedo SR 100 Zydol SR 100 | |||||||||||||||||||||||||||||||||
|
|
|
|
| ||||||||||||||||||||||||||||||||||||
|
|
|
|
| ||||||||||||||||||||||||||||||||||||
| Tablet (extended release) containing tramadol hydrochloride 100 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 20 | .. | Durotram XR | |||||||||||||||||||||||||||||||||
| Tablet (sustained release) containing tramadol hydrochloride 150 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 40 | .. | APO-Tramadol SR Chem mart Tramadol SR Lodam SR 150 Terry White Chemists Tramadol SR Tramahexal SR Tramal SR 150 Tramedo SR 150 Zydol SR 150 | |||||||||||||||||||||||||||||||||
| Tablet (sustained release) containing tramadol hydrochloride 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 40 | .. | APO-Tramadol SR Chem mart Tramadol SR Lodam SR 200 Terry White Chemists Tramadol SR Tramahexal SR Tramal SR 200 Tramedo SR 200 Zydol SR 200 | |||||||||||||||||||||||||||||||||
| Tablet (extended release) containing tramadol hydrochloride 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 20 | .. | Durotram XR | |||||||||||||||||||||||||||||||||
| Tablet (extended release) containing tramadol hydrochloride 300 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 20 | .. | Durotram XR | |||||||||||||||||||||||||||||||||
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics | Oral | 2 | .. | Tramal | |||||||||||||||||||||||||||||||||
Ustekinumab | Injection 45 mg in 0.5 mL |
| Chronic plaque psoriasis (whole body) — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: | Injection | 1 | 2 | Stelara | |||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (whole body) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 1 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the most recent PASI assessment is no more than 1 month old at the time of application; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (iii) the signed patient and prescriber acknowledgements; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 28 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with ustekinumab for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Chronic plaque psoriasis (face, hand, foot) — initial treatment 2 |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (c) have not failed PBS-subsidised therapy with ustekinumab for the treatment of this condition in the current Treatment Cycle; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| patients who have previously demonstrated a response to PBS-subsidised treatment with ustekinumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised ustekinumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| (ii) details of prior biological agent treatment, including dosage, date and duration of treatment; |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 28 weeks of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with ustekinumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 28 weeks, and where approval of the application would enable the patient to complete a course of 28 weeks of treatment in total |
|
|
|
| |||||||||||||||||||||||||||||||||
Valaciclovir | Tablet 500 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 30 | 5 | Valtrex | |||||||||||||||||||||||||||||||||
| Tablet 500 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash Herpes zoster ophthalmicus | Oral | 42 | .. | Valtrex | |||||||||||||||||||||||||||||||||
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) |
| Endophthalmitis Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | Injection | 5 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz | |||||||||||||||||||||||||||||||||
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) |
| Endophthalmitis Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | Injection | 3 | .. | Hospira Pty Limited Vancomycin Sandoz | |||||||||||||||||||||||||||||||||
Zolmitriptan | Tablet 2.5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS-listed drugs | Oral | 4 | 5 | Zomig | |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS-listed drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS-listed drugs |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance |
|
|
|
| |||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences |
|
|
|
| |||||||||||||||||||||||||||||||||
SCHEDULE 2 – PART 1 | |||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand |
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | .. | Difflam |
Bisacodyl | Tablet 5 mg | Oral | 200 | .. | Bisalax Lax-Tab |
| Suppositories 10 mg, 10 | Rectal | 3 | .. | Dulcolax Petrus Bisacodyl Suppositories |
| Suppositories 10 mg, 12 | Rectal | 3 | .. | Petrus Bisacodyl Suppositories |
| Enemas 10 mg in 5 mL, 25 | Rectal | 1 | .. | Bisalax |
Carmellose | Mouth spray containing carmellose sodium 10 mg per mL, 25 mL | Oral application | 1 | .. | Aquae |
| Mouth spray containing carmellose sodium 10 mg per mL, 100 mL | Oral application | 1 | .. | Aquae |
Clonazepam | Tablet 500 micrograms | Oral | 100 | .. | Paxam 0.5 Rivotril |
| Tablet 2 mg | Oral | 100 | .. | Paxam 2 Rivotril |
| Oral liquid 2.5 mg per mL, 10 mL | Oral | 2 | .. | Rivotril |
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 |
|
|
|
|
| Valium |
|
|
|
|
| Valpam 2 |
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 |
|
|
|
|
| Diazepam-DP |
|
|
|
|
| Diazepam-GA |
|
|
|
|
| Ranzepam |
|
|
|
|
| Valium |
|
|
|
|
| Valpam 5 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | .. | APO-Diclofenac |
|
|
|
|
| Chem mart Diclofenac |
|
|
|
|
| Clonac 25 |
|
|
|
|
| Diclofenac-GA |
|
|
|
|
| Diclohexal |
SCHEDULE 2 – PART 1 — continued | |||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand |
|
|
|
|
| Fenac 25 |
|
|
|
|
| Terry White Chemists Diclofenac |
|
|
|
|
| Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | .. | Chem mart Diclofenac |
|
|
|
|
| Clonac 50 |
|
|
|
|
| Diclofenac-GA |
|
|
|
|
| Diclohexal |
|
|
|
|
| Fenac |
|
|
|
|
| GenRx Diclofenac |
|
|
|
|
| Terry White Chemists Diclofenac |
|
|
|
|
| Voltaren 50 |
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | .. | Voltaren 100 |
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
Glycerol | Suppositories 700 mg, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 1.4 g, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 2.8 g, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
Hyoscine | Injection containing hyoscine butylbromide 20 mg in 1 mL | Injection | 5 | .. | Buscopan |
Hypromellose | Oral gel 20 mg per g, 100 g | Oral application | 1 | . . | Aquae Gel |
Ibuprofen | Tablet 200 mg | Oral | 100 | .. | Rafen 200 |
| Tablet 400 mg | Oral | 90 | .. | Brufen |
Indomethacin | Capsule 25 mg | Oral | 100 | .. | Arthrexin Indocid |
| Suppository 100 mg | Rectal | 40 | .. | Indocid |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Oral | 1 | .. | Actilax |
|
|
|
|
| Duphalac |
|
|
|
|
| Genlac |
|
|
|
|
| GenRx Lactulose |
|
|
|
|
| Lac-Dol |
|
|
|
|
| Lactocur |
Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 | Oral | 1 | .. | Movicol-Half |
| Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | 1 | .. | Movicol |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL | Oral | 1 | .. | Sigma Pharmaceuticals (Australia) Pty Ltd |
Methylnaltrexone | Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL | Injection | 3 | . . | Relistor |
Morphine | Tablet containing morphine sulfate 10 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 20 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 200 mg (controlled release) | Oral | 20 | .. | MS Contin |
Naproxen | Tablet containing naproxen sodium 550 mg | Oral | 50 | .. | Anaprox 550 Crysanal |
| Tablet 250 mg | Oral | 100 | .. | Inza 250 Naprosyn |
| Tablet 500 mg | Oral | 50 | .. | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | Oral | 28 | .. | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | Oral | 28 | .. | Naprosyn SR1000 Proxen SR 1000 |
| Oral suspension 125 mg per 5 mL, 474 mL | Oral | 1 | .. | Naprosyn |
Nitrazepam | Tablet 5 mg | Oral | 50 | .. | Alodorm Mogadon |
Oxazepam | Tablet 15 mg | Oral | 50 | .. | Alepam 15 Serepax |
| Tablet 30 mg | Oral | 50 | .. | Alepam 30 Murelax Serepax |
Paracetamol | Tablet 665 mg (modified release) | Oral | 192 | .. | Panadol Osteo |
| Suppositories 500 mg, 24 | Rectal | 1 | .. | Panadol |
Promethazine | Tablet containing promethazine hydrochloride 10 mg | Oral | 50 | .. | Phenergan |
| Tablet containing promethazine hydrochloride 25 mg | Oral | 50 | .. | Phenergan |
| Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL | Oral | 1 | .. | Phenergan |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 | Rectal | 2 | .. | Microlax |
Sterculia with Frangula Bark | Granules 620 mg-80 mg per g, 500 g | Oral | 1 | .. | Normacol Plus |
Sulindac | Tablet 100 mg | Oral | 100 | .. | Aclin |
| Tablet 200 mg | Oral | 50 | .. | Aclin 200 |
Temazepam | Tablet 10 mg | Oral | 50 | .. | APO-Temazepam Normison Temaze Temtabs |
SCHEDULE 2 – PART 2 | ||||||
Listed Drug | Form (strength, type, size, etc.) | Purposes | Manner of administration | Maximum quantity | Maximum number of repeats | Brand |
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Difflam |
Bisacodyl | Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 200 | 3 | Bisalax Lax-Tab |
| Suppositories 10 mg, 10 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Dulcolax Petrus Bisacodyl Suppositories |
| Suppositories 10 mg, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Bisacodyl Suppositories |
| Enemas 10 mg in 5 mL, 25 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 1 | 3 | Bisalax |
Carmellose | Mouth spray containing carmellose sodium 10 mg per mL, 25 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Aquae |
SCHEDULE 2 – PART 2 — continued | ||||||
Listed Drug | Form (strength, type, size, etc.) | Purposes | Manner of administration | Maximum quantity | Maximum number of repeats | Brand |
| Mouth spray containing carmellose sodium 10 mg per mL, 100 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Aquae |
Clonazepam | Tablet 500 micrograms | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Paxam 0.5 Rivotril |
| Tablet 2 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Paxam 2 Rivotril |
| Oral liquid 2.5 mg per mL, 10 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 2 | 3 | Rivotril |
Diazepam | Tablet 2 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Antenex 2 Valium Valpam 2 |
|
| |||||
|
| |||||
|
| |||||
| Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Antenex 5 Diazepam-DP Diazepam-GA Ranzepam Valium Valpam 5 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | APO-Diclofenac Chem mart Diclofenac Clonac 25 Diclofenac-GA Diclohexal Fenac 25 Terry White Chemists Diclofenac Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Chem mart Diclofenac Clonac 50 Diclofenac-GA Diclohexal Fenac GenRx Diclofenac Terry White Chemists Diclofenac Voltaren 50 |
| Suppository containing diclofenac sodium 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 40 | 3 | Voltaren 100 |
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | 2 | Actiq |
|
| Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred |
|
|
|
|
| Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
Glycerol | Suppositories 700 mg, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 1.4 g, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 2.8 g, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
Hyoscine | Injection containing hyoscine butylbromide 20 mg in 1 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred | Injection | 5 | 3 | Buscopan |
Hypromellose | Oral gel 20 mg per g, 100 g | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Aquae Gel |
Ibuprofen | Tablet 200 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Rafen 200 |
| Tablet 400 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 90 | 3 | Brufen |
Indomethacin | Capsule 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Arthrexin Indocid |
| Suppository 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 40 | 3 | Indocid |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Actilax Duphalac Genlac GenRx Lactulose Lac-Dol Lactocur |
Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Movicol-Half |
| Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Movicol |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 2 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Methylnaltrexone | Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone Second and subsequent continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone, and where consultation with a palliative care specialist or service has occurred | Injection | 7 | 3 | Relistor |
| Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL | In compliance with authority procedures set out in subparagraph 11 (d): Continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone | Injection | 7 | .. | Relistor |
Morphine | Tablet containing morphine sulfate 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | Sevredol |
| Tablet containing morphine sulfate 20 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | Sevredol |
| Tablet containing morphine sulfate 200 mg (controlled release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | MS Contin |
Naproxen | Tablet 250 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Inza 250 Naprosyn |
| Tablet containing naproxen sodium 550 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Anaprox 550 Crysanal |
| Tablet 500 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 28 | 3 | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 28 | 3 | Naprosyn SR1000 Proxen SR 1000 |
| Oral suspension 125 mg per 5 mL, 474 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Naprosyn |
Nitrazepam | Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alodorm Mogadon |
Oxazepam | Tablet 15 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alepam 15 Serepax |
| Tablet 30 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alepam 30 Murelax Serepax |
Paracetamol | Tablet 665 mg (modified release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred | Oral | 192 | 3 | Panadol Osteo |
| Suppositories 500 mg, 24 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred | Rectal | 1 | 3 | Panadol |
Promethazine | Tablet containing promethazine hydrochloride 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Phenergan |
| Tablet containing promethazine hydrochloride 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Phenergan |
| Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Phenergan |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 2 | 3 | Microlax |
Sterculia with Frangula Bark | Granules 620 mg-80 mg per g, 500 g | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Normacol Plus |
Sulindac | Tablet 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Aclin |
| Tablet 200 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Aclin 200 |
Temazepam | Tablet 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | APO-Temazepam Normison Temaze Temtabs |
SCHEDULE 3 – PART 1 | |||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand |
Adrenaline | Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000) | Injection | 5 | .. | AstraZeneca Pty Ltd |
Amoxycillin | Capsule 250 mg (as trihydrate) | Oral | 20 | .. | Alphamox 250 |
|
|
|
|
| Amoxil |
|
|
|
|
| Amoxycillin-DP |
|
|
|
|
| Amoxycillin-GA |
|
|
|
|
| Amoxycillin Ranbaxy Amoxycillin Sandoz |
|
|
|
|
| APO-Amoxycillin |
|
|
|
|
| Chem mart Amoxycillin |
|
|
|
|
| Cilamox |
|
|
|
|
| GenRx Amoxycillin |
|
|
|
|
| Terry White Chemists Amoxycillin |
| Capsule 500 mg (as trihydrate) | Oral | 20 | .. | Alphamox 500 |
|
|
|
|
| Amoxil |
|
|
|
|
| Amoxycillin-DP |
|
|
|
|
| Amoxycillin Ranbaxy |
|
|
|
|
| Amoxycillin Sandoz |
|
|
|
|
| APO-Amoxycillin |
|
|
|
|
| Chem mart Amoxycillin |
|
|
|
|
| Cilamox |
|
|
|
|
| GenRx Amoxycillin |
|
|
|
|
| Moxacin |
|
|
|
|
| Terry White Chemists Amoxycillin |
| Sachet containing oral powder 3 g (as trihydrate) | Oral | 1 | .. | Amoxil |
| Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL | Oral | 1 | .. | Amoxil |
| Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Alphamox 125 Amoxil Amoxycillin Sandoz Bgramin Chem mart Amoxycillin GenRx Amoxycillin Ranmoxy Terry White Chemists Amoxycillin |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
SCHEDULE 3 – PART 1 — continued | |||||
Listed Drug | Form (strength, type, size, etc.) | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand |
| Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Alphamox 250 |
|
|
|
|
| Amoxil Forte |
|
|
|
|
| Amoxycillin Sandoz |
|
|
|
|
| Bgramin |
|
|
|
|
| Chem mart Amoxycillin |
|
|
|
|
| Cilamox |
|
|
|
|
| GenRx Amoxycillin |
|
|
|
|
| Ranmoxy |
|
|
|
|
| Terry White Chemists Amoxycillin |
| Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Maxamox |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | .. | APO-Amoxycillin/Clavulanic Acid 500/125 Augmentin Duo |
|
|
|
|
| Clamoxyl Duo |
|
|
|
|
| Curam Duo 500/125 |
|
|
|
|
| GA-Amclav 500/125 |
|
|
|
|
| Moxiclav Duo 500/125 |
| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | .. | Augmentin Duo forte |
|
|
|
|
| Chem mart Amoxycillin and Clavulanic Acid |
|
|
|
|
| Clamoxyl Duo forte |
|
|
|
|
| Clavycillin 875/125 |
|
|
|
|
| Curam Duo Forte 875/125 |
|
|
|
|
| GA-Amclav Forte 875/125 |
|
|
|
|
| GenRx Amoxycillin and Clavulanic Acid |
|
|
|
|
| Moxiclav Duo Forte 875/125 |
|
|
|
|
| Terry White Chemists Amoxycillin and Clavulanic Acid |
| Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Oral | 1 | .. | Augmentin Curam Clamoxyl |
| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | 1 | .. | Augmentin Duo 400 Curam Duo Clamoxyl Duo 400 |
Amphotericin | Lozenge 10 mg | Oral | 20 | .. | Fungilin |
Ampicillin | Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Austrapen Ibimicyn |
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Aspen Ampicyn Austrapen Ibimicyn |
Aspirin | Tablet, dispersible, 300 mg | Oral | 96 | .. | Solprin |
Atropine | Injection containing atropine sulfate 600 micrograms in 1 mL | Injection | 10 | .. | AstraZeneca Pty Ltd |
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre-filled syringe | Injection | 10 | .. | Bicillin L-A |
Benztropine | Injection containing benztropine mesylate 2 mg in 2 mL | Injection | 5 | .. | Cogentin |
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | .. | Difflam |
Benzylpenicillin | Powder for injection 600 mg (as sodium) | Injection | 10 | .. | BenPen |
| Powder for injection 3 g (as sodium) | Injection | 10 | .. | BenPen |
Betamethasone | Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL | Injection | 5 | .. | Celestone Chronodose |
Carbamazepine | Tablet 100 mg | Oral | 200 | .. | Carbamazepine Sandoz Tegretol 100 |
| Tablet 200 mg | Oral | 200 | .. | Carbamazepine Sandoz Tegretol 200 Teril |
| Tablet 200 mg (controlled release) | Oral | 200 | .. | Tegretol CR 200 |
| Tablet 400 mg (controlled release) | Oral | 200 | .. | Tegretol CR 400 |
| Oral suspension 100 mg per 5 mL, 300 mL | Oral | 1 | .. | Tegretol Liquid |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Oral | 10 | .. | Ceclor CD |
|
|
|
|
| Cefaclor-GA |
|
|
|
|
| Chem mart Cefaclor CD |
|
|
|
|
| Douglas Cefaclor-CD |
|
|
|
|
| GenRx Cefaclor CD |
|
|
|
|
| Karlor CD |
|
|
|
|
| Keflor CD |
|
|
|
|
| Ozcef |
|
|
|
|
| Terry White Chemists Cefaclor CD |
| Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Oral | 1 | .. | Aclor 125 |
|
|
|
|
| Ceclor |
|
|
|
|
| Cefaclor Sandoz |
|
|
|
|
| Chem mart Cefaclor |
|
|
|
|
| GenRx Cefaclor |
|
|
|
|
| Keflor |
|
|
|
|
| Ozcef |
|
|
|
|
| Terry White Chemists Cefaclor |
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Oral | 1 | .. | Aclor 250 |
|
|
|
|
| Ceclor |
|
|
|
|
| Cefaclor Sandoz |
|
|
|
|
| Chem mart Cefaclor |
|
|
|
|
| GenRx Cefaclor |
|
|
|
|
| Keflor |
|
|
|
|
| Ozcef |
|
|
|
|
| Terry White Chemists Cefaclor |
Cefalotin | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefalotin Sandoz Hospira Pty Limited Keflin Neutral |
Cefotaxime | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited |
| Powder for injection 2 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited |
Cefuroxime | Tablet 250 mg (as axetil) | Oral | 14 | .. | Zinnat |
Cephalexin | Capsule 250 mg (anhydrous) | Oral | 20 | .. | Cefalexin Sandoz |
|
|
|
|
| Cephabell |
|
|
|
|
| Cephalexin generichealth |
|
|
|
|
| Cephatrust 250 |
|
|
|
|
| Chem mart Cephalexin |
|
|
|
|
| Cilex |
|
|
|
|
| GenRx Cephalexin |
|
|
|
|
| Ialex |
|
|
|
|
| Ibilex 250 |
|
|
|
|
| Keflex |
|
|
|
|
| Rancef |
|
|
|
|
| Terry White Chemists Cephalexin |
| Capsule 500 mg (anhydrous) | Oral | 20 | .. | Cefalexin Sandoz |
|
|
|
|
| Cephabell |
|
|
|
|
| Cephalexin generichealth |
|
|
|
|
| Cephatrust 500 |
|
|
|
|
| Chem mart Cephalexin |
|
|
|
|
| Cilex |
|
|
|
|
| GenRx Cephalexin |
|
|
|
|
| Ialex |
|
|
|
|
| Ibilex 500 |
|
|
|
|
| Keflex |
|
|
|
|
| Rancef |
|
|
|
|
| Terry White Chemists Cephalexin |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Oral | 1 | .. | Cefalexin Sandoz |
|
|
|
|
| Chem mart Cephalexin |
|
|
|
|
| Cilex |
|
|
|
|
| GenRx Cephalexin |
|
|
|
|
| Ialex |
|
|
|
|
| Ibilex 125 |
|
|
|
|
| Keflex |
|
|
|
|
| Terry White Chemists Cephalexin |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Oral | 1 | .. | Cefalexin Sandoz |
|
|
|
|
| Chem mart Cephalexin |
|
|
|
|
| Cilex |
|
|
|
|
| GenRx Cephalexin |
|
|
|
|
| Ialex |
|
|
|
|
| Ibilex 250 |
|
|
|
|
| Keflex |
|
|
|
|
| Terry White Chemists Cephalexin |
Chloramphenicol | Eye drops 5 mg per mL, 10 mL | Application to the eye | 1 | .. | Chloromycetin Chlorsig |
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | 24 | .. | Cleocin Dalacin C |
Codeine | Tablet containing codeine phosphate 30 mg | Oral | 20 | .. | Fawns and McAllan Proprietary Limited |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Oral | 20 | .. | APO-Paracetamol/Codeine 500/30 Codalgin Forte |
|
|
|
|
| Codapane Forte |
|
|
|
|
| Comfarol Forte |
|
|
|
|
| Dolaforte |
|
|
|
|
| Panadeine Forte |
|
|
|
|
| Prodeine Forte |
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 |
|
|
|
|
| Valium |
|
|
|
|
| Valpam 2 |
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 |
|
|
|
|
| Diazepam-DP |
|
|
|
|
| Diazepam-GA |
|
|
|
|
| Ranzepam |
|
|
|
|
| Valium |
|
|
|
|
| Valpam 5 |
| Injection 10 mg in 2 mL ampoule | Injection | 5 | .. | Hospira Pty Limited |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | .. | APO-Diclofenac |
|
|
|
|
| Chem mart Diclofenac |
|
|
|
|
| Clonac 25 |
|
|
|
|
| Diclofenac-GA |
|
|
|
|
| Diclohexal |
|
|
|
|
| Fenac 25 |
|
|
|
|
| Terry White Chemists Diclofenac |
|
|
|
|
| Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | .. | Chem mart Diclofenac |
|
|
|
|
| Clonac 50 |
|
|
|
|
| Diclofenac-GA |
|
|
|
|
| Diclohexal |
|
|
|
|
| Fenac |
|
|
|
|
| GenRx Diclofenac |
|
|
|
|
| Terry White Chemists Diclofenac |
|
|
|
|
| Voltaren 50 |
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | .. | Voltaren 100 |
Dicloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Dicloxsig Distaph 250 |
| Capsule 500 mg (as sodium) | Oral | 24 | .. | DiclocilDicloxsig Distaph 500 |
Doxycycline | Tablet 100 mg (as monohydrate) | Oral | 7 | .. | Chem mart Doxycycline |
|
|
|
|
| Doxyhexal |
|
|
|
|
| GenRx Doxycycline |
|
|
|
|
| Terry White Chemists Doxycycline |
| Tablet 100 mg (as hydrochloride) | Oral | 7 | .. | Doxsig |
|
|
|
|
| Doxy-100 |
|
|
|
|
| Doxylin 100 |
|
|
|
|
| Vibramycin |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 7 | .. | DBL Doxycycline Doryx |
Erythromycin | Tablet 400 mg (as ethyl succinate) | Oral | 25 | .. | E.E.S. 400 Filmtab E-Mycin |
| Capsule 250 mg (containing enteric coated pellets) | Oral | 25 | .. | DBL Erythromycin Eryc |
| Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | .. | E.E.S. 200 E-Mycin 200 |
| Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | .. | E.E.S. Granules E-Mycin 400 |
| Powder for I.V. infusion 1 g (as lactobionate) | Injection | 5 | .. | Erythrocin-I.V. |
Flucloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 250 |
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 500 |
| Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited |
| Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited |
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Flubiclox Flucil |
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Flubiclox Flucil Hospira Pty Limited |
Glucagon | Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe | Injection | 1 | .. | GlucaGen Hypokit |
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | . . | B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited |
| I.V. infusion 278 mmol (anhydrous) per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Ltd B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited |
Glyceryl Trinitrate | Tablets 600 micrograms, 100 | Buccal/sublingual | 1 | .. | Anginine Stabilised Lycinate |
Hydrocortisone | Injection 100 mg (as sodium succinate) with 2 mL solvent | Injection | 6 | .. | Solu-Cortef |
| Injection 250 mg (as sodium succinate) with 2 mL solvent | Injection | 6 | .. | Solu-Cortef |
| Cream containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | .. | Cortic-DS 1% Sigmacort |
| Cream containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | .. | Cortef Cortic-DS 1% Sigmacort |
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | .. | Cortic-DS 1% Sigmacort |
| Ointment containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | .. | Cortic-DS 1% Sigmacort |
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg | Oral | 20 | .. | Dilaudid |
| Tablet containing hydromorphone hydrochloride 4 mg | Oral | 20 | .. | Dilaudid |
| Tablet containing hydromorphone hydrochloride 8 mg | Oral | 20 | .. | Dilaudid |
| Tablet (modified release) containing hydromorphone hydrochloride 4 mg | Oral | 10 | .. | Jurnista |
| Tablet (modified release) containing hydromorphone hydrochloride 8 mg | Oral | 10 | .. | Jurnista |
| Tablet (modified release) containing hydromorphone hydrochloride 16 mg | Oral | 10 | .. | Jurnista |
| Tablet (modified release) containing hydromorphone hydrochloride 32 mg | Oral | 10 | .. | Jurnista |
| Tablet (modified release) containing hydromorphone hydrochloride 64 mg | Oral | 10 | .. | Jurnista |
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL | Oral | 1 | .. | Dilaudid |
| Injection containing hydromorphone hydrochloride 2 mg in 1 mL | Injection | 5 | .. | Dilaudid |
| Injection containing hydromorphone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Dilaudid-HP |
| Injection containing hydromorphone hydrochloride 50 mg in 5 mL | Injection | 5 | .. | Dilaudid-HP |
Ibuprofen | Tablet 200 mg | Oral | 100 | .. | Rafen 200 |
| Tablet 400 mg | Oral | 30 | .. | Brufen |
Indomethacin | Capsule 25 mg | Oral | 100 | .. | Arthrexin Indocid |
| Suppository 100 mg | Rectal | 40 | .. | Indocid |
Ketoprofen | Capsule 200 mg (sustained release) | Oral | 28 | .. | Orudis SR 200 Oruvail SR |
| Suppository 100 mg | Rectal | 40 | .. | Orudis |
Lignocaine | Injection containing lignocaine hydrochloride 100 mg in 5 mL | Injection | 5 | .. | Pfizer Australia Pty Ltd |
Lincomycin | Injection 600 mg (as hydrochloride) in 2 mL | Injection | 5 | .. | Lincocin |
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Injection | 5 | .. | Depo-Medrol Depo-Nisolone |
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Oral | 25 | .. | Maxolon Pramin |
| Injection containing metoclopramide hydrochloride 10 mg in 2 mL | Injection | 10 | .. | Maxolon |
Metronidazole | Tablet 200 mg | Oral | 21 | .. | Flagyl Metrogyl 200 Metronide 200 |
| Tablet 400 mg | Oral | 5 | .. | Metrogyl 400 |
| Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL | Oral | 1 | .. | Flagyl S |
| I.V. infusion 500 mg in 100 mL | Injection | 5 | .. | Baxter Healthcare Pty Ltd DBL Metronidazole Intravenous Infusion Metronidazole Sandoz |
| Suppositories 500 mg, 10 | Rectal | 1 | .. | Flagyl |
Morphine | Tablet containing morphine sulfate 30 mg | Oral | 20 | .. | Anamorph |
| Tablet containing morphine sulfate 5 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 10 mg (controlled release) | Oral | 20 | .. | Momex SR 10 MS Contin |
| Tablet containing morphine sulfate 15 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 30 mg (controlled release) | Oral | 20 | .. | Momex SR 30 MS Contin |
| Tablet containing morphine sulfate 60 mg (controlled release) | Oral | 20 | .. | Momex SR 60 MS Contin |
| Tablet containing morphine sulfate 100 mg (controlled release) | Oral | 20 | .. | Momex SR 100 MS Contin |
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 30 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 60 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 90 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 120 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Oral | 20 | .. | MS Contin Suspension 20 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Oral | 20 | .. | MS Contin Suspension 30 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Oral | 20 | .. | MS Contin Suspension 60 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Oral | 20 | .. | MS Contin Suspension 100 mg |
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral | 1 | .. | Ordine 2 |
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral | 1 | .. | Ordine 5 |
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral | 1 | .. | Ordine 10 |
| Injection containing morphine sulfate 10 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing morphine sulfate 15 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing morphine sulfate 30 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
Naloxone | Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set | Injection | 1 | .. | Naloxone Min-I-Jet |
Naproxen | Tablet 250 mg | Oral | 100 | .. | Inza 250 Naprosyn |
| Tablet containing naproxen sodium 550 mg | Oral | 50 | .. | Anaprox 550 Crysanal |
| Tablet 500 mg | Oral | 50 | .. | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | Oral | 28 | .. | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | Oral | 28 | .. | Naprosyn SR1000 Proxen SR 1000 |
Nitrazepam | Tablet 5 mg | Oral | 25 | .. | Alodorm Mogadon |
Nystatin | Tablet 500,000 units | Oral | 50 | .. | Nilstat |
| Capsule 500,000 units | Oral | 50 | .. | Nilstat |
| Oral suspension 100,000 units per mL, 24 mL | Oral | 1 | .. | Mycostatin Nilstat |
Oxazepam | Tablet 15 mg | Oral | 25 | .. | Alepam 15 Serepax |
| Tablet 30 mg | Oral | 25 | .. | Alepam 30 Murelax Serepax |
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | Endone |
| Capsule containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | OxyNorm |
| Capsule containing oxycodone hydrochloride 10 mg | Oral | 20 | .. | OxyNorm |
| Capsule containing oxycodone hydrochloride 20 mg | Oral | 20 | .. | OxyNorm |
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL | Oral | 1 | .. | OxyNorm Liquid 5mg/5mL |
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 15 mg (controlled release) | Oral | 20 | . . | OxyContin |
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 30 mg (controlled release) | Oral | 20 | . . | OxyContin |
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Suppository 30 mg (as pectinate) | Rectal | 12 | .. | Proladone |
Paracetamol | Tablet 500 mg | Oral | 100 | .. | APO-Paracetamol |
|
|
|
|
| Chem mart Paracetamol |
|
|
|
|
| Dymadon P |
|
|
|
|
| Febridol |
|
|
|
|
| Generic Health Pty Ltd |
|
|
|
|
| Panamax |
|
|
|
|
| Paracetamol Sandoz |
|
|
|
|
| Paralgin |
|
|
|
|
| Pharmacy Choice Paracetamol |
|
|
|
|
| Terry White Chemists Paracetamol |
| Oral liquid 120 mg per 5 mL, 100 mL | Oral | 1 | .. | Panamax |
| Oral liquid 240 mg per 5 mL, 200 mL | Oral | 1 | .. | Panamax 240 Elixir |
Phenoxymethylpenicillin | Tablet 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin-VK Filmtab |
| Tablet 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin-VK Filmtab |
| Capsule 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK |
|
|
|
|
| Cilopen VK |
|
|
|
|
| LPV |
| Capsule 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK |
|
|
|
|
| Cilopen VK |
|
|
|
|
| LPV |
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | .. | Abbocillin-V Cilicaine V |
Piroxicam | Dispersible tablet 10 mg | Oral | 50 | .. | Mobilis D-10 |
| Dispersible tablet 20 mg | Oral | 25 | .. | Feldene-D |
|
|
|
|
| Mobilis D-20 |
| Capsule 10 mg | Oral | 50 | .. | Chem mart Piroxicam |
|
|
|
|
| Feldene |
|
|
|
|
| GenRx Piroxicam |
|
|
|
|
| Mobilis 10 |
|
|
|
|
| Terry White Chemists Piroxicam |
| Capsule 20 mg | Oral | 25 | .. | Chem mart Piroxicam |
|
|
|
|
| Feldene |
|
|
|
|
| GenRx Piroxicam |
|
|
|
|
| Mobilis 20 |
|
|
|
|
| Terry White Chemists Piroxicam |
Procaine Penicillin | Injection 1.5 g in disposable syringe | Injection | 5 | .. | Cilicaine |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Oral | 25 | .. | Stemetil Stemzine |
| Injection containing prochlorperazine mesylate 12.5 mg in 1 mL | Injection | 10 | .. | Stemetil |
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 | Rectal | 1 | .. | Stemetil |
Promethazine | Injection containing promethazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Hospira Pty Limited |
Sodium Chloride | Injection 9 mg per mL, 10 mL | injection/solvent for injectables | 5 | .. | Pfizer Australia Pty Ltd |
| I.V. infusion 77 mmol per 500 mL, 500 mL | Injection | 5 | . . | B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited |
| I.V. infusion 154 mmol per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Ltd B. Braun Australia Pty Ltd Pharmatel Fresenius Kabi Pty Limited |
| I.V. infusion 513 mmol per L, 1 L | Injection | 2 | .. | Baxter Healthcare Pty Ltd |
Sodium Chloride with Glucose | I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Ltd |
| I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | .. | Baxter Healthcare Pty Ltd |
| I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | .. | Baxter Healthcare Pty Ltd |
Sulindac | Tablet 100 mg | Oral | 100 | .. | Aclin |
| Tablet 200 mg | Oral | 50 | .. | Aclin 200 |
Temazepam | Tablet 10 mg | Oral | 25 | .. | APO-Temazepam Normison Temaze Temtabs |
Ticarcillin with Clavulanic Acid | Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Timentin |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Chem mart Tramadol |
|
|
|
|
| GenRx Tramadol |
|
|
|
|
| Lodam 50 |
|
|
|
|
| Terry White Chemists Tramadol |
|
|
|
|
| Tramal |
|
|
|
|
| Tramedo |
|
|
|
|
| Zydol |
| Tablet (sustained release) containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Tramal SR 50 |
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR |
|
|
|
|
| Lodam SR 100 |
|
|
|
|
| Terry White Chemists Tramadol SR |
|
|
|
|
| Tramahexal SR |
|
|
|
|
| Tramal SR 100 |
|
|
|
|
| Tramedo SR 100 |
|
|
|
|
| Zydol SR 100 |
| Tablet (extended release) containing tramadol hydrochloride 100 mg | Oral | 10 | .. | Durotram XR |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR |
|
|
|
|
| Lodam SR 150 |
|
|
|
|
| Terry White Chemists Tramadol SR |
|
|
|
|
| Tramahexal SR |
|
|
|
|
| Tramal SR 150 |
|
|
|
|
| Tramedo SR 150 |
|
|
|
|
| Zydol SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Oral | 20 | .. | APO-Tramadol SR Chem mart Tramadol SR |
|
|
|
|
| Lodam SR 200 |
|
|
|
|
| Terry White Chemists Tramadol SR |
|
|
|
|
| Tramahexal SR |
|
|
|
|
| Tramal SR 200 |
|
|
|
|
| Tramedo SR 200 |
|
|
|
|
| Zydol SR 200 |
| Tablet (extended release) containing tramadol hydrochloride 200 mg | Oral | 10 | .. | Durotram XR |
| Tablet (extended release) containing tramadol hydrochloride 300 mg | Oral | 10 | .. | Durotram XR |
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | 1 | .. | Tramal |
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | 5 | .. | Tramahexal |
|
|
|
|
| Tramal 100 |
Triamcinolone | Injection containing triamcinolone acetonide 10 mg in 1 mL | Injection | 5 | .. | Kenacort-A10 |
Trimethoprim with Sulfamethoxazole | Tablet 80 mg-400 mg | Oral | 10 | .. | Resprim |
| Tablet 160 mg-800 mg | Oral | 10 | .. | Bactrim DS |
|
|
|
|
| Resprim Forte |
|
|
|
|
| Septrin Forte |
| Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL | Oral | 1 | .. | Bactrim Septrin |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | 2 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz |
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | 1 | .. | Hospira Pty Limited Vancomycin Sandoz |
SCHEDULE 3 – PART 2 | ||||||
Listed Drug | Form (strength, type, size, etc.) | Purposes | Manner of adminis- tration | Maximum quantity | Maximum number of repeats | Brand |
Ibuprofen | Tablet 400 mg | Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease | Oral | 90 | .. | Brufen |
Metronidazole | Tablet 400 mg | Treatment of anaerobic infections | Oral | 21 | .. | Flagyl Metrogyl 400 Metronide 400 |
Paracetamol | Tablet 500 mg | Chronic arthropathies | Oral | 300 | .. | APO-Paracetamol |
|
|
|
|
|
| Chem mart Paracetamol |
|
|
|
|
|
| Dymadon P |
|
|
|
|
|
| Febridol |
|
|
|
|
|
| Generic Health Pty Ltd |
|
|
|
|
|
| Panamax |
|
|
|
|
|
| Paracetamol Sandoz |
|
|
|
|
|
| Paralgin |
|
|
|
|
|
| Pharmacy Choice Paracetamol |
|
|
|
|
|
| Terry White Chemists Paracetamol |
SCHEDULE 4 | ||||
Form of Medicinal Preparation | Maximum quantity | Maximum number of repeats | ||
Creams | 100 g | 1 | ||
Dusting Powders | 100 g | 1 | ||
Ear Drops | 15 mL | 2 | ||
Eye Drops containing Cocaine Hydrochloride BP | 15 mL | .. | ||
Eye Drops, Other | 15 mL | 5 | ||
Eye Lotions | 200 mL | 2 | ||
Inhalations | 50 mL | 1 | ||
Linctuses containing Codeine Phosphate BP | 100 mL | .. | ||
Linctuses, Other | 100 mL | 2 | ||
Lotions | 200 mL | 2 | ||
Mixtures containing Codeine Phosphate BP | 200 mL | .. | ||
Mixtures, Other | 200 mL | 4 | ||
Mixtures for Children containing Codeine Phosphate BP | 100 mL | .. | ||
Mixtures for Children, Other | 100 mL | 4 | ||
Mouth Washes | 200 mL | 1 | ||
Nasal Instillations | 15 mL | 2 | ||
Ointments, Waxes | 100 g | 1 | ||
Paints | 25 mL | 1 | ||
Pastes containing Cocaine Hydrochloride BP | 25 g | .. | ||
Pastes, Other | 100 g | 1 | ||
Powders for Internal Use | 100 g | 2 | ||
Solutions | 200 mL | 2 | ||
Notes to the Determination — Pharmaceutical benefits (PB 114 of 2008)
Note 1
The Determination — Pharmaceutical benefits (PB 114 of 2008) (in force under sections 85, 85A and 88 of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
Title | Date of FRLI Registration | Date of | Application, saving or |
PB 114 of 2008 | 26 Nov 2008 (see F2008L04397) | 1 Dec 2008 |
|
PB 125 of 2008 | 11 Dec 2008 (see F2008L04635) | 1 Jan 2009 | — |
PB 2 of 2009 | 14 Jan 2009 (see F2009L00043) | 1 Feb 2009 | — |
PB 9 of 2009 | 12 Feb 2009 (see F2009L00423) | 1 Mar 2009 | — |
PB 21 of 2009 | 20 Mar 2009 (see F2009L01072) | 1 Apr 2009 | — |
PB 32 of 2009 | 8 Apr 2009 (see F2009L01249) | 1 May 2009 | — |
PB 40 of 2009 | 13 May 2009 (see F2009L01712) | 1 June 2009 | — |
PB 48 of 2009 | 12 June 2009 (see F2009L02288) | 1 July 2009 | — |
PB 63 of 2009 | 13 July 2009 (see F2009L02706) | 1 Aug 2009 | — |
PB 76 of 2009 | 17 Aug 2009 (see F2009L03149) | 1 Sept 2009 | — |
PB 87 of 2009 | 17 Sept 2009 (see F2009L03545) | 1 Oct 2009 | — |
PB 97 of 2009 | 13 Oct 2009 (see F2009L03821) | 1 Nov 2009 | — |
PB 107 of 2009 | 20 Nov 2009 (see F2009L04284) | 1 Dec 2009 | — |
PB 119 of 2009 | 9 Dec 2009 (see F2009L04557) | 1 Jan 2010 | — |
PB 129 of 2009 | 13 Jan 2010 (see F2010L00101) | 1 Feb 2010 | — |
PB 5 of 2010 | 17 Feb 2010 (see F2010L00472) | 1 Mar 2010 | — |
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
Provision affected | How affected |
S. 3..................... | am. PB 9 of 2009 |
Schedule 1 |
|
Part 1 |
|
Part 1................... | am. PB 125 of 2008; PB 2, 9, 21, 32, 40, 48, 63, 76, 87, 97, 107, 119 and 129 of 2009; PB 5 of 2010 |
Part 2 |
|
Part 2................... | am. PB 125 of 2008; PB 2, 9, 21, 32, 40, 48, 63, 76, 87, 97, 107, 119 and 129 of 2009; PB 5 of 2010 |
Schedule 2 |
|
Part 1 |
|
Part 1................... | am. PB 9, 63, 87 ,97, 107, 119 and 129 of 2009; PB 5 of 2010 |
Part 2 |
|
Part 2................... | am. PB 9, 63, 87 ,97, 107, 119 and 129 of 2009; PB 5 of 2010 |
Schedule 3 |
|
Part 1 |
|
Part 1................... | am. PB 125 of 2008; PB 9, 21, 32, 40, 48, 63, 76, 87, 97, 107, 119 and 129 of 2009; PB 5 of 2010 |
Part 2 |
|
Part 2................... | am. PB 125 of 2008; PB 48, 63 and 107 of 2009; PB 5 of 2010 |