National Health Act 1953 - Declaration under subsection 85(2) (No. PB 26 of 2005) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85(2)
No. PB 26 of 2005
I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subsection 85(2) of the National Health Act 1953, hereby make the following Declaration:
1.This declaration commences on 1 October 2005.
2. Declaration No. PB 16 of 2005 under subsection 85(2) of the National Health Act 1953 made on 26 July 2005 with effect from 1 August 2005 is repealed.
3. In this Declaration:
“Act” means the National Health Act 1953;
“base-priced drug” means —
(a) in relation to cimetidine hydrochloride or ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or
(b) in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): 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 ramipril (capsule 10 mg): captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril erbumine or quinapril hydrochloride or ramipril (tablet 1.25 mg or tablet 2.5 mg or tablet 5 mg) or trandolapril;
“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;
“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;
“Managing Director” means the Managing Director of the Health Insurance Commission established under the Health Insurance Commission Act 1973;
“ready-prepared pharmaceutical benefit” means a drug or medicinal preparation in respect of which there is in force a determination under subsection 85(6) of the Act;
“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
4.Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances (if any) specified in column 2 of Schedule 1 or 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner.
4A. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 2 and the circumstances (if any) specified in column 2 of Schedule 2 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a participating dental practitioner.
5. A medicinal preparation composed of a compound that includes a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3, other than a compound the name of which is specified in column 2 of that Schedule opposite the name of that pharmaceutical benefit, is not a medicinal preparation to which Part VII of the Act applies, unless the name of that pharmaceutical benefit is also specified in Schedule 4, in which case the provisions of paragraphs 7 and 8 apply.
6. Part VII of the Act does not apply in relation to a medicinal preparation composed of a compound that includes a ready-prepared pharmaceutical benefit, other than sterilised Water for Injections, Sodium Chloride injection or a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3.
7. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4.
8. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4 with the addition of one or more of the substances the names of which are specified in Schedule 5.
9. The substances the names of which are specified in Schedule 5 are additives for the purposes of paragraph 85(2)(b) of the Act.
10. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in Schedule 6.
11. The drugs and medicinal preparations the names of which are specified in Schedule 6 are additional pharmaceutical benefits made available under arrangements provided for by section 100 of the Act.
12. Where circumstances are specified in column 2 of Schedule 1, 1A, 2 or 4 opposite the name of a pharmaceutical benefit specified in column 1 of any of those Schedules, that pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.
13. Where circumstances are specified in column 2 of Schedule 4 opposite the name of a pharmaceutical benefit specified in column 1 of that Schedule, those circumstances are also specified in relation to any medicinal preparation containing that pharmaceutical benefit.
14. Subject to paragraph 16, the following circumstances are specified in relation to each relevant pharmaceutical benefit for the purposes of section 88A of the Act:
(a) where a class of persons is specified in column 2 of Schedule 1, 1A, 2 or 4 — 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 column 2 of Schedule 1, 1A, 2 or 4 —
(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 column 2 of Schedule 1, 1A, 2 or 4 — that the pharmaceutical benefit is to be supplied for that purpose;
(d) where it is specified in column 2 of Schedule 1 or 1A that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner has submitted to the Managing Director a prescription for the supply of the pharmaceutical benefit:
(i)by preparing and signing the prescription:
(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 Managing Director, 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 Managing Director 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 Managing Director 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 Managing Director; or
(iv)by submitting the prescription by giving the Managing Director, by means of an electronic communication of a kind approved in writing by the Managing Director, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).
14A. For the purposes of subsubparagraph 14(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.
15. Subject to paragraph 15B, the authorisation of a prescription submitted under subparagraph 14(d) may be made:
(a) if the prescription was submitted in accordance with subsubparagraph 14(d)(i) — by the Managing Director signing his or her authorisation of the prescription on it and:
(i) if the Managing Director 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 14(d)(ii) — orally, at the time the Managing Director is given details of the prescription; or
(c) if the prescription was submitted in accordance with subsubparagraph 14(d)(iv) — by the Managing Director sending his or her authorisation, by electronic communication, to the medical practitioner.
15A. If the Managing Director authorises a prescription in accordance with subparagraph 15(b) or (c):
(a) the Managing Director 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.
15B. Notwithstanding paragraph 15, if the prescription was submitted in accordance with subsubparagraph 14(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 Managing Director.
16. Where the circumstances “For use in accordance with paragraph 16” are specified in column 2 of Schedule 1, the circumstances specified for the purpose of subparagraph 14(c) are that the pharmaceutical benefit is to be supplied for the treatment of a patient who, after dietary therapy, qualifies for the supply of the benefit in accordance with the following table:
Category of patient Lipid level (1) patients with existing coronary heart disease cholesterol greater than 4 mmol per L (2) patients, not in category (1), with 1 or more of the following:
diabetes mellitus;
familial hypercholesterolaemia;
family history of cardiovascular disease (first degree relative less than 60 years of age);
hypertension;
peripheral vascular disease
cholesterol greater than 6.5 mmol per L; or
cholesterol greater than 5.5 mmol per L and high density lipoprotein less than 1 mmol per L
(3) patients, not in category (1) or (2), with high density lipoprotein level less than 1 mmol per L cholesterol greater than 6.5 mmol per L (4) patients, not in category (1), (2) or (3), being men over 34 but less than 76 years of age or post-menopausal women less than 76 years of age cholesterol greater than 7.5 mmol per L; or
triglyceride greater than 4 mmol per L
(5) patients, not in category (1), (2), (3) or (4) cholesterol greater than 9 mmol per L; or
triglyceride greater than 8 mmol per L
Abciximab In compliance with authority procedures set out in subparagraph 14 (d): Patients undergoing percutaneous coronary balloon angioplasty Patients undergoing percutaneous coronary atherectomy Patients undergoing percutaneous coronary stent placement Acamprosate Calcium In compliance with authority procedures set out in subparagraph 14 (d): For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence Acarbose — Acetazolamide — Acetazolamide Sodium — Acetylcysteine Sodium Bronchiectasis Cystic fibrosis Aciclovir In respect of the eye ointment 30 mg per g, 4.5 g: Herpes simplex keratitis In respect of the tablet 200 mg: In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe initial genital herpes 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) by an accredited pathology laboratory but where commencement of treatment need not await confirmation of diagnosis, and where pathology reports from accredited laboratories confirming the diagnosis are available for audit by the Health Insurance Commission, unless the patient commenced suppressive therapy prior to 1 May 2004 and is continuing on suppressive therapy, in which case the patient is exempt from the requirement for microbiological confirmation of diagnosis and confirmatory pathology reports are not required to be available for audit In respect of the tablet 800 mg: In compliance with authority procedures set out in subparagraph 14 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash Herpes zoster ophthalmicus Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L) Acitretin In compliance with authority procedures set out in subparagraph 14 (d): Severe intractable psoriasis Severe forms of disorders of keratinisation Adalimumab In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment in 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 with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who 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 alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) 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 that particular agent (or agents) only; or
(ii) 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
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 (b) 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);
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;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate 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 treatment 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 14 (d)(i) or 14(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 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
patients are eligible to commence therapy with adalimumab within this bDMARD 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, and provided they also meet the conditions applying to recommencement of adalimumab therapy specified below, if applicable;
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 if:
(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the Health Insurance Commission, 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
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 authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of adalimumab therapy;
a course of treatment 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 14 (d)(i) or 14(d)(ii): Continuation of initial treatment, or of a course which recommences 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 severe active rheumatoid arthritis who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
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
Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
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
Continuing treatment 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 with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with adalimumab; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; andwhere 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
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;
the authority application includes a completed copy of the appropriate 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 Health Insurance Commission, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of adalimumab therapy was an initial 16 week 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 treatment 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 14 (d)(i) or 14 (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 severe active rheumatoid arthritis who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above Adrenaline In compliance with authority procedures set out in subparagraph 14 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient 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 the name of the specialist consulted is included in the authority application Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug Adrenaline Acid Tartrate — Albendazole In respect of the tablet 200 mg: In compliance with authority procedures set out in subparagraph 14 (d): Treatment of tapeworm infestation In respect of the tablet 400 mg: In compliance with authority procedures set out in subparagraph 14 (d): For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used Alendronate Sodium In respect of the tablet equivalent to 70 mg alendronic acid: In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug In respect of the tablet equivalent to 40 mg alendronic acid: In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone "Alfaré" In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children aged 2 years and over, 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 Biliary atresia Chronic liver failure with fat malabsorption Chylous ascites Chylothorax Cystic fibrosis Enterokinase deficiency Proven fat malabsorption Severe diarrhoea of greater than 2 weeks' duration in infants under the age of 4 months, where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome Allopurinol — Alprazolam In compliance with authority procedures set out in subparagraph 14 (d): Panic disorder where other treatments have failed or are inappropriate Alteplase Treatment of acute myocardial infarction within 12 hours of onset of attack Aluminium Hydroxide - Dried with Magnesium Hydroxide — Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide — Amantadine Hydrochloride Parkinson's disease which is not drug induced Amiloride Hydrochloride — Aminoglutethimide — Amiodarone Hydrochloride Severe cardiac arrhythmias Amisulpride In compliance with authority procedures set out in subparagraph 14 (d): Schizophrenia Amitriptyline Hydrochloride — Amlodipine Besylate — Amoxycillin Trihydrate In respect of the tablet, chewable, equivalent to 250 mg amoxycillin, capsule equivalent to 250 mg amoxycillin, capsule equivalent to 500 mg amoxycillin and sachet containing oral powder equivalent to 3 g amoxycillin: — In respect of the tablet equivalent to 1 g amoxycillin: Acute exacerbations of chronic bronchitis Amoxycillin Trihydrate with Potassium Clavulanate Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven Amoxycillin Trihydrate with Water - Purified BP — Amphotericin — Ampicillin Sodium — Ampicillin Trihydrate — Anakinra In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment in 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 with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who 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 alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) 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 that particular agent (or agents) only; or
(ii) 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
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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;
failure to achieve an adequate response to the treatment regimens specified at (b) 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);
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;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate 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 treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (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 are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
patients are eligible to commence therapy with anakinra within this bDMARD 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, and provided they also meet the conditions applying to recommencement of anakinra therapy specified below, if applicable; unless this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, in which case the patient is eligible to commence therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised anakinra treatment; and
(ii) the response was assessed, and the assessment was provided to the Health Insurance Commission, 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
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 authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of anakinra therapy;
a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii): Continuation of initial treatment, or of a course which recommences 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 severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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;
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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;
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment 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 with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with anakinra; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;
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;
the authority application includes a completed copy of the appropriate 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 Health Insurance Commission, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of anakinra therapy was an initial 16 week 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 treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (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 severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above Anastrozole Treatment of hormone-dependent advanced breast cancer in post-menopausal women Treatment of hormone-dependent early breast cancer in post-menopausal women in whom tamoxifen citrate therapy is contraindicated Treatment of hormone-dependent early breast cancer in post-menopausal women who are intolerant of tamoxifen citrate Apraclonidine Hydrochloride Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy Aprepitant In compliance with authority procedures set out in subparagraph 14 (d): Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:
altretamine;
carmustine;
cisplatin, when a single dose constitutes a cycle of chemotherapy;
cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
dacarbazine;
procarbazine, when a single dose constitutes a cycle of chemotherapy;
streptozocinAripiprazole In compliance with authority procedures set out in subparagraph 14 (d): Schizophrenia Aspirin — Atenolol — Atorvastatin Calcium For use in accordance with paragraph 16 Atovaquone In compliance with authority procedures set out in subparagraph 14 (d): Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy Atropine Sulfate — Auranofin — Azathioprine — Azithromycin Dihydrate Uncomplicated urethritis due to Chlamydia trachomatis Uncomplicated cervicitis due to Chlamydia trachomatis Trachoma Azithromycin Dihydrate with Water - Purified BP Trachoma Baclofen — Balsalazide Sodium In compliance with authority procedures set out in subparagraph 14 (d): Mild to moderate ulcerative colitis where hypersensitivity to sulfonamides exists Mild to moderate ulcerative colitis where intolerance to sulfasalazine exists "BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain) Treatment of carcinoma in situ of the urinary bladder "BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain) Primary and relapsing superficial urothelial carcinoma of the bladder Beclomethasone Dipropionate In respect of the pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation): — In respect of the pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation): Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug Benzathine Penicillin — Benzhexol Hydrochloride — Benztropine Mesylate — Benzydamine Hydrochloride Radiation induced mucositis Benzyl Benzoate — Benzylpenicillin Sodium — Betamethasone Acetate with Betamethasone Sodium Phosphate Alopecia areata For local intra-articular or peri-articular infiltration Granulomata, dermal Keloid Lichen planus hypertrophic Lichen simplex chronicus Lupus erythematosus, chronic discoid Necrobiosis lipoidica Uveitis Betamethasone Dipropionate Treatment of corticosteroid-responsive dermatoses Betamethasone Valerate Treatment of corticosteroid-responsive dermatoses Betaxolol Hydrochloride — Bethanechol Chloride — Bicalutamide In compliance with authority procedures set out in subparagraph 14 (d): Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy Bimatoprost — Biperiden Hydrochloride — Bisacodyl Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities 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 Patients receiving palliative care Terminal malignant neoplasia Anorectal congenital abnormalities Megacolon Bisoprolol Fumarate In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated Bivalirudin Trifluoroacetate In compliance with authority procedures set out in subparagraph 14 (d): Patients undergoing non-emergency percutaneous coronary intervention Bleomycin Sulfate Germ cell neoplasms Lymphoma Brimonidine Tartrate — Brimonidine Tartrate with Timolol Maleate Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Brinzolamide — Bromocriptine Mesylate In respect of the tablet equivalent to 2.5 mg bromocriptine: Prevention of the onset of lactation in the puerperium for medical reasons 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 In respect of the capsule equivalent to 5 mg bromocriptine and capsule equivalent to 10 mg bromocriptine: 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 Budesonide In respect of the powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses, powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses and powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses: — In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30: In compliance with authority procedures set out in subparagraph 14 (d): Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy Budesonide with Eformoterol Fumarate Dihydrate Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide Bupropion Hydrochloride In compliance with authority procedures set out in subparagraph 14 (d): Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where details of the program are specified in the authority application Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who are entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug Busulfan — Cabergoline In respect of the tablet 500 micrograms: Prevention of the onset of lactation in the puerperium for medical reasons In compliance with authority procedures set out in subparagraph 14 (d): 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 In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg: Parkinson's disease Calcipotriol Chronic stable plaque type psoriasis vulgaris Calcitriol In compliance with authority procedures set out in subparagraph 14 (d): Hypocalcaemia due to renal disease Hypoparathyroidism Hypophosphataemic rickets Vitamin D-resistant rickets Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug Calcium Carbonate Hyperphosphataemia in chronic renal failure Hypocalcaemia Osteoporosis Proven calcium malabsorption Calcium Citrate Hyperphosphataemia in chronic renal failure Hypocalcaemia Osteoporosis Proven calcium malabsorption Calcium Folinate In respect of the injection equivalent to 50 mg folinic acid in 5 mL and injection equivalent to 100 mg folinic acid in 10 mL: — In respect of the tablet equivalent to 15 mg folinic acid: Antidote to folic acid antagonists Candesartan Cilexetil — Candesartan Cilexetil with Hydrochlorothiazide Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil Capecitabine In compliance with authority procedures set out in subparagraph 14 (d): Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy Treatment of advanced or metastatic colorectal cancer "Caprilon" Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders Captopril In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg: — In respect of the oral solution 5 mg per mL, 95 mL: For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor Carbachol — Carbamazepine — Carbimazole — "Carbohydrate Free Mixture" Patients with intractable seizures requiring treatment with a ketogenic diet Glucose transport protein defects Pyruvate dehydrogenase deficiency Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance Carbomer 974 In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops Carbomer 980 In respect of the ocular lubricating gel 2 mg per g, 10 g: Severe dry eye syndrome, including Sjogren's syndrome In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30: In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops Carboplatin — Carmellose Sodium In respect of the eye drops 5 mg per mL, 15 mL and eye drops 10 mg per mL, 15 mL: Severe dry eye syndrome, including Sjogren's syndrome In respect of the eye drops 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops 5 mg per mL, single dose units 0.4 mL, 30, eye drops 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops Carvedilol In respect of the pack containing 30 tablets 3.125 mg, 30 tablets 6.25 mg and 10 tablets 12.5 mg: In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated In respect of the tablet 3.125 mg, tablet 6.25 mg, tablet 12.5 mg and tablet 25 mg: In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 Cefaclor Monohydrate — Cefaclor Monohydrate with Water - Purified BP — Cefepime Hydrochloride In compliance with authority procedures set out in subparagraph 14 (d): Treatment of febrile neutropenia Cefotaxime Sodium Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven Ceftriaxone Sodium In respect of the injection equivalent to 250 mg ceftriaxone, vial (with required solvent): Gonorrhoea Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven In respect of the injection equivalent to 500 mg ceftriaxone, vial (with required solvent), injection equivalent to 1 g ceftriaxone, vial (with required solvent) and injection equivalent to 2 g ceftriaxone, vial (with required solvent): Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven Cefuroxime Axetil — Celecoxib Symptomatic treatment of osteoarthritis Symptomatic treatment of rheumatoid arthritis Cephalexin — Cephalexin with Water - Purified BP — Cephalothin Sodium — Cephazolin Sodium Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven Chlorambucil — Chloramphenicol — Chlorpromazine Hydrochloride — Chlorthalidone — Cholestyramine — Chorionic Gonadotrophin In respect of the injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL: Anovulatory infertility For the treatment of infertility in males due to hypogonadotrophic hypogonadism For the treatment of infertility in males associated with isolated luteinising hormone deficiency For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty Cryptorchism not due to organic obstruction in boys over 12 months of age In respect of the injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL: Anovulatory infertility For the treatment of infertility in males due to hypogonadotrophic hypogonadism For the treatment of infertility in males associated with isolated luteinising hormone deficiency For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty Ciclesonide — Cimetidine — Cimetidine Hydrochloride — Ciprofloxacin Hydrochloride In respect of the tablet equivalent to 250 mg ciprofloxacin: Gonorrhoea In compliance with authority procedures set out in subparagraph 14 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients 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 In respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin: In compliance with authority procedures set out in subparagraph 14 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients 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 In respect of the eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL: In compliance with authority procedures set out in subparagraph 14 (d): Bacterial keratitis Cisplatin — Citalopram Hydrobromide Major depressive disorders Cladribine In compliance with authority procedures set out in subparagraph 14 (d): Hairy cell leukaemia Clarithromycin — Clindamycin Hydrochloride Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin Clomiphene Citrate Anovulatory infertility Patients undergoing in-vitro fertilisation Clomipramine Hydrochloride Cataplexy associated with narcolepsy Obsessive-compulsive disorder Phobic disorders in adults Clonazepam In respect of the injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent): Epilepsy In respect of the tablet 500 micrograms, tablet 2 mg and oral liquid 2.5 mg per mL, 10 mL: In compliance with authority procedures set out in subparagraph 14 (d): Neurologically proven epilepsy Clonidine Hydrochloride — Clopidogrel Hydrogen Sulfate In compliance with authority procedures set out in subparagraph 14 (d): Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events: in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs Prevention of recurrence of myocardial infarction or unstable angina: in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs Codeine Phosphate — Codeine Phosphate with Paracetamol — Colchicine — Colestipol Hydrochloride — Copper Sulfate — Cortisone Acetate — Cyclophosphamide — Cyclosporin In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application Cyproheptadine Hydrochloride Prevention of migraine Cyproterone Acetate In respect of the tablet 50 mg: In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women Advanced carcinoma of the prostate To reduce drive in sexual deviations in males In respect of the tablet 100 mg: In compliance with authority procedures set out in subparagraph 14 (d): Advanced carcinoma of the prostate To reduce drive in sexual deviations in males Cytarabine — Dalteparin Sodium — Danazol In compliance with authority procedures set out in subparagraph 14 (d): Endometriosis, visually proven Hereditary angio-oedema Treatment, for up to 6 months, of intractable primary menorrhagia Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments Dantrolene Sodium Treatment of chronic spasticity Dapsone — Demeclocycline Hydrochloride Syndrome of inappropriate antidiuretic hormone secretion, which is not drug induced Desmopressin Acetate In respect of the intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle: In compliance with authority procedures set out in subparagraph 14 (d): Cranial diabetes insipidus In respect of the tablet 200 micrograms and nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL: In compliance with authority procedures set out in subparagraph 14 (d): Primary nocturnal enuresis:
in patients aged 6 years or older for whom an enuresis alarm is contraindicated, where the reason for the contraindication is included in the authority application, and where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose Cranial diabetes insipidus Dexamethasone — Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin — Dexamethasone Sodium Phosphate — Dexamphetamine Sulfate In compliance with authority procedures set out in subparagraph 14 (d): Use in attention deficit hyperactivity disorder, in accordance with State/Territory law Narcolepsy "Dialamine" Gyrate atrophy of the choroid and retina Urea cycle disorders Diazepam — Diclofenac Sodium In respect of the suppository 100 mg: — In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated): Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease In respect of the eye drops 1 mg per mL, 5 mL: Inhibition of intraoperative miosis Dicloxacillin Sodium In respect of the injection equivalent to 500 mg dicloxacillin, vial (with required solvent) and injection equivalent to 1 g dicloxacillin, vial (with required solvent): — In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin: Serious staphylococcal infections Diflunisal Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease "Digestelact" In compliance with authority procedures set out in subparagraph 14 (d): Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose 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 either by the 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 by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet Digoxin — Dihydroergotamine Mesylate — Diltiazem Hydrochloride — Diphenoxylate Hydrochloride with Atropine Sulfate — Diphtheria and Tetanus Vaccine - Adsorbed — Diphtheria and Tetanus Vaccine - Adsorbed (Diluted) — Dipivefrine Hydrochloride — Dipyridamole Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events: in patients receiving therapy with low-dose aspirin in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs Dipyridamole with Aspirin Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events Disodium Etidronate In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects Heterotopic ossification Disodium Etidronate and Calcium Carbonate In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug Disodium Pamidronate In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone Disopyramide — Docetaxel In compliance with authority procedures set out in subparagraph 14 (d): 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 Locally advanced or metastatic non-small cell lung cancer Docusate Sodium with Bisacodyl Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities 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 Patients receiving palliative care Terminal malignant neoplasia Anorectal congenital abnormalities Megacolon Dolasetron Mesylate Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy Domperidone — Donepezil Hydrochloride In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy
Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i):
Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy
Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Dorzolamide Hydrochloride — Dorzolamide Hydrochloride with Timolol Maleate Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Dothiepin Hydrochloride — Doxepin Hydrochloride — Doxorubicin Hydrochloride — Doxorubicin Hydrochloride - Pegylated Liposomal In compliance with authority procedures set out in subparagraph 14 (d): Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated Doxycycline Hydrochloride In respect of the tablet equivalent to 100 mg doxycycline and capsule equivalent to 100 mg doxycycline (containing enteric coated pellets): — In respect of the tablet equivalent to 50 mg doxycycline and capsule equivalent to 50 mg doxycycline (containing enteric coated pellets): Bronchiectasis in patients aged 8 years or older Chronic bronchitis in patients aged 8 years or older Severe acne Doxycycline Monohydrate In respect of the tablet equivalent to 100 mg doxycycline: — In respect of the tablet equivalent to 50 mg doxycycline: Bronchiectasis in patients aged 8 years or older Chronic bronchitis in patients aged 8 years or older Severe acne Drotrecogin Alfa (Activated) In compliance with authority procedures set out in subparagraph 14 (d): Adult patients with severe sepsis who have a high risk of death as determined by acute dysfunction in at least 2 organs or modified Acute Physiology and Chronic Health Evaluation II score of at least 25, where acute organ dysfunction is defined as follows:
For cardiovascular-system dysfunction, an arterial systolic blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;
For kidney dysfunction, urine output of less than 0.5 mL per kg of body weight per hour for 1 hour despite adequate fluid resuscitation;
For respiratory-system dysfunction, a ratio of partial pressure of oxygen in arterial blood (in mmHg) to the percentage of oxygen in the inspired air (expressed as a decimal) of less than or equal to 250;
For haematologic dysfunction, a platelet count of less than 80,000 per cubic millimetre or which has decreased by 50 percent in the previous 3 days;
In the case of unexplained metabolic acidosis, a pH of less than or equal to 7.30 or a base deficit of greater than or equal to 5.0 mmol per L in association with a plasma lactate level of greater than 1.5 times the upper limit of the normal value for the reporting laboratory"Duocal" Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae Dydrogesterone — "Easiphen" Phenylketonuria Eformoterol Fumarate Dihydrate Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids "EleCare" In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children 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 Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children 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 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 Enalapril Maleate — Enalapril Maleate with Hydrochlorothiazide Hypertension in patients who are not adequately controlled with 20 mg enalapril maleate "Energivit" Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae Enoxaparin Sodium — Entacapone In compliance with authority procedures set out in subparagraph 14 (d): Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect Epirubicin Hydrochloride — Eprosartan Mesylate — Eprosartan Mesylate with Hydrochlorothiazide Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy Eptifibatide Acetate In compliance with authority procedures set out in subparagraph 14 (d): Patients undergoing non-urgent percutaneous intervention with intracoronary stenting Erythromycin — Erythromycin Ethyl Succinate — Erythromycin Ethyl Succinate with Water - Purified BP — Erythromycin Lactobionate — Escitalopram Oxalate Major depressive disorders In compliance with authority procedures set out in subparagraph 14 (d): Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences Esomeprazole Magnesium Trihydrate In respect of the tablet (enteric coated), equivalent to 40 mg esomeprazole: Healing of gastro-oesophageal reflux disease In respect of the tablet (enteric coated), equivalent to 20 mg esomeprazole: Maintenance of healed gastro-oesophageal reflux disease Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate Eradication of Helicobacter pylori associated with peptic ulcer disease Etanercept In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who have not received any treatment with either etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with either of these drugs, have not received PBS-subsidised treatment with 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, where the patient has received non-PBS-subsidised treatment with etanercept or infliximab, have not received non-PBS-subsidised treatment with etanercept prior to 1 July 2004; and
(c) who have 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
(d) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and
(e) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), in combination with an appropriate exercise program, for a total period of at least 3 months, unless:
(i) treatment with NSAIDs is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, in which case the patient is exempt from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or
(ii) adverse events of a severity necessitating permanent treatment withdrawal develop during the relevant period of use of 2 NSAIDs, in which case the patient may be exempted from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or
(iii) the patient is unable to complete the minimum exercise program, in which case the patient is exempt from completing the exercise component of the combined NSAID and exercise treatment regimen specified above; or
(iv) the patient has had a break in PBS-subsidised therapy with 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, instead of the combined NSAID and exercise regimen specified above; and
(f) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either 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 one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with 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 reasons 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 reasons why a higher dose cannot be used;
where the patient is exempted from the minimum 3 months of treatment with at least 2 NSAIDs because treatment with NSAIDs is contraindicated, the authority application includes evidence supporting the contraindication;
an appropriate minimum exercise program includes stretch and range of motion exercises 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 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 copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and
(iii) a copy of the completed BASDAI Assessment Form; and
(iv) a copy of the signed patient acknowledgment form; and
(v) a copy of the exercise program self-certification form detailing the program followed and the dates over which it was followed; and
(b) confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed in the self-certification form;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis and who, in this treatment cycle, have received prior PBS-subsidised treatment with etanercept or with infliximab for this condition as 'new' patients and have not failed PBS-subsidised therapy with etanercept more than once; 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either 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 one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and
where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and
where the following conditions apply:
patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;
the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form;
the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where:
(i) the response assessment is provided to the Health Insurance Commission no later than 4 weeks from the date that course was ceased; and
(ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of treatment with etanercept subsidised under the Pharmaceutical Benefits Scheme (PBS) as 'new' patients, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either 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 one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and
where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and
where the following conditions apply:
patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;
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;
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 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:
(i) the response assessment is provided to the Health Insurance Commission no later than 4 weeks from the date that course of treatment ceased; and
(ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course;
the application for authorisation includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form, including 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 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept as 'new' patients for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(ii):
Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks of initial PBS-subsidised treatment with etanercept as 'new' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Health Insurance Commission by facsimile
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with etanercept more than once; 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either 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 one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and
where the following conditions apply:
patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;
the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form;
the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where:
(i) the response assessment is provided to the Health Insurance Commission no later than 4 weeks from the date that course was ceased; and
(ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of a treatment cycle with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with etanercept prior to 1 July 2004; and
(a) who are receiving treatment with etanercept at the time of application; and
(b) who have not received prior PBS-subsidised treatment with infliximab; and
(c) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and
(d) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale; and
(e) who have:
(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
(f) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with 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 the following conditions apply:
the BASDAI assessment and the ESR and CRP measurements are no more than 1 month old at the time of application;
the application for authorisation includes a completed copy of the appropriate 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 copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and
(iii) a copy of the completed BASDAI Assessment Form; and
(iv) a copy of the signed patient acknowledgment 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 14 (d)(i) or14 (d)(ii):
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were receiving non-PBS-subsidised treatment with etanercept prior to 1 July 2004 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised 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
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab, who have received 6 weeks or more of PBS-subsidised treatment with etanercept, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was 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 etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either 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 one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and
where the following conditions apply:
patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle;
response to treatment is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, and:
(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 pre-treatment baseline;
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 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:
(i) the response assessment is provided to the Health Insurance Commission no later than 4 weeks from the date that course of treatment ceased; and
(ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course;
the application for authorisation includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form including 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 14 (d)(i) or 14 (d)(ii):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing PBS-subsidised treatment with etanercept for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d)(ii):
Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of initial PBS-subsidised treatment with etanercept as 'grandfathered' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Health Insurance Commission by facsimile
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment in 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 with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who 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 alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) 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 that particular agent (or agents) only; or
(ii) 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
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 (b) 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);
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;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate 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 treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (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 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
patients are eligible to commence therapy with etanercept within this bDMARD 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, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;
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 if:
(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and
(ii) the response was assessed, and the assessment was provided to the Health Insurance Commission, 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
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 authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy;
a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (d)(ii):
Continuation of initial treatment, or of a course which recommences 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 severe active rheumatoid arthritis who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above
In compliance with authority procedures set out in subsubparagraph 14 (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 alone or leflunomide in combination with methotrexate or cyclosporin alone, 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 14 (d)(i) or 14(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
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment 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 with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with etanercept; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
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;
the authority application includes a completed copy of the appropriate 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 Health Insurance Commission, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of etanercept therapy was an initial 16 week 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 treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14 (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 severe active rheumatoid arthritis who 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; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above
In compliance with authority procedures set out in subsubparagraph 14 (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 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
Ethacrynic Acid Patients hypersensitive to other oral diuretics Ethosuximide — Etonogestrel — Etoposide — Etoposide Phosphate — Everolimus In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application Exemestane Treatment of hormone-dependent advanced breast cancer in post-menopausal women with disease progression following treatment with tamoxifen citrate Ezetimibe In compliance with authority procedures set out in subparagraph 14 (d): For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is unsuitable because the patient developed a clinically important product-related adverse event during treatment with a statin and required discontinuation of all statin treatment, and where a clinically important product-related adverse event is defined as follows:
Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statinHomozygous sitosterolaemia Treatment of patients with homozygous familial hypercholesterolaemia whose cholesterol level, after dietary therapy, is greater than 6.5 mmol per L or greater than 5.5 mmol per L in patients with a high density lipoprotein level of less than 1 mmol per L, when used in combination with an HMG CoA reductase inhibitor (statin) Initial treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 4 mmol per L after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application Initial treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application Continuing treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease or diabetes mellitus whose cholesterol levels were inadequately controlled with a statin, where the patient has previously been issued with an authority prescription for this drug Famciclovir In respect of the tablet 125 mg: In compliance with authority procedures set out in subparagraph 14 (d): Episodic treatment 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) by an accredited pathology laboratory but where commencement of treatment need not await confirmation of diagnosis, and where pathology reports from accredited laboratories confirming the diagnosis are available for audit by the Health Insurance Commission In respect of the tablet 250 mg: In compliance with authority procedures set out in subparagraph 14 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash 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) by an accredited pathology laboratory but where commencement of treatment need not await confirmation of diagnosis, and where pathology reports from accredited laboratories confirming the diagnosis are available for audit by the Health Insurance Commission, unless the patient commenced suppressive therapy prior to 1 May 2004 and is continuing on suppressive therapy, in which case the patient is exempt from the requirement for microbiological confirmation of diagnosis and confirmatory pathology reports are not required to be available for audit Famotidine — Felodipine — Fenofibrate For use in accordance with paragraph 16 Fentanyl Chronic severe disabling pain which is associated with proven malignant neoplasia and which is unresponsive to non-narcotic analgesics Ferrous Sulfate — Flecainide Acetate Serious supra-ventricular cardiac arrhythmias Serious ventricular cardiac arrhythmias where treatment is initiated in a hospital (in-patient or out-patient) Flucloxacillin Magnesium with Water - Purified BP Serious staphylococcal infections Flucloxacillin Sodium In respect of the injection equivalent to 500 mg flucloxacillin, vial (with required solvent) and injection equivalent to 1 g flucloxacillin, vial (with required solvent): — In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin: Serious staphylococcal infections Fluconazole In compliance with authority procedures set out in subparagraph 14 (d): Treatment of cryptococcal meningitis in patients unable to take or tolerate amphotericin Maintenance therapy in patients with cryptococcal meningitis and immunosuppression Treatment of oropharyngeal candidiasis in immunosuppressed patients Treatment of oesophageal candidiasis in immunosuppressed patients Secondary prophylaxis of oropharyngeal candidiasis in immunosuppressed patients Treatment of serious and life-threatening candida infections in patients unable to tolerate amphotericin Fludrocortisone Acetate — Fluorometholone — Fluorometholone Acetate — Fluorouracil Sodium — Fluoxetine Hydrochloride Major depressive disorders Obsessive-compulsive disorder Flupenthixol Decanoate — Fluphenazine Decanoate — Flurbiprofen Sodium — Flutamide In compliance with authority procedures set out in subparagraph 14 (d): Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy Fluticasone Propionate — Fluticasone Propionate with Salmeterol Xinafoate Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate Fluvastatin Sodium For use in accordance with paragraph 16 Fluvoxamine Maleate Major depressive disorders Obsessive-compulsive disorder Folic Acid — Follitropin Alfa In respect of the injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL and the injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL: Anovulatory infertility In respect of the injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL, injection 300 I.U. in 0.5 mL multi-dose cartridge, injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL, injection 450 I.U. in 0.75 mL multi-dose cartridge and injection 900 I.U. in 1.5 mL multi-dose cartridge: Anovulatory infertility In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis Follitropin Beta In respect of the solution for injection 100 I.U. in 0.5 mL single use vial and solution for injection 150 I.U. in 0.5 mL single use vial: Anovulatory infertility In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis In respect of the solution for injection 200 I.U. in 0.5 mL single use vial: In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis In respect of the solution for injection 300 I.U. in 0.36 mL multi-dose cartridge and solution for injection 600 I.U. in 0.72 mL multi-dose cartridge: Anovulatory infertility Fondaparinux Sodium In compliance with authority procedures set out in subparagraph 14 (d): Prevention of venous thromboembolic events in patients undergoing major hip surgery Prevention of venous thromboembolic events in patients undergoing total knee replacement Fosinopril Sodium — Fosinopril Sodium with Hydrochlorothiazide Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or fosinopril sodium monotherapy Fotemustine In compliance with authority procedures set out in subparagraph 14 (d): Metastatic malignant melanoma Framycetin Sulfate — Frusemide — Frusemide Sodium — Gabapentin
Bisacodyl In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Carmellose Sodium In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where dry mouth is a symptom, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom, and where a palliative care patient is 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 Continuing supply for palliative care patients where dry mouth is a symptom, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Clonazepam In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients for the prevention of epilepsy, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy, and where a palliative care patient is 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 Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Docusate Sodium with Bisacodyl In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Glycerol In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Hyoscine Butylbromide In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where colicky pain is a symptom, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom, and where a palliative care patient is 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 Continuing supply for palliative care patients where colicky pain is a symptom, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Paracetamol In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where a palliative care patient is 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 Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Promethazine Hydrochloride In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where nausea or vomiting is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where nausea or vomiting is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where nausea or vomiting is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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 Sterculia with Frangula Bark In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is 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 Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is 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
Adrenaline Acid Tartrate — Amoxycillin Trihydrate — Amoxycillin Trihydrate with Potassium Clavulanate Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven Amoxycillin Trihydrate with Water - Purified BP — Amphotericin — Ampicillin Sodium — Ampicillin Trihydrate — Aspirin — Atropine Sulfate — Benzathine Penicillin — Benztropine Mesylate — Benzydamine Hydrochloride Radiation induced mucositis Benzylpenicillin Sodium — Betamethasone Acetate with Betamethasone Sodium Phosphate For local intra-articular or peri-articular infiltration Keloid Lichen planus hypertrophic Carbamazepine — Cefaclor Monohydrate — Cefaclor Monohydrate with Water - Purified BP — Cefotaxime Sodium Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Cefuroxime Axetil — Cephalexin — Cephalexin with Water - Purified BP — Cephalothin Sodium — Chloramphenicol — Clindamycin Hydrochloride Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin Codeine Phosphate — Codeine Phosphate with Paracetamol — Diazepam — Diclofenac Sodium In respect of the suppository 100 mg: — In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated): Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Dicloxacillin Sodium In respect of the injection equivalent to 500 mg dicloxacillin, vial (with required solvent) and injection equivalent to 1 g dicloxacillin, vial (with required solvent): — In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin: Serious staphylococcal infections Diflunisal Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Doxycycline Hydrochloride — Doxycycline Monohydrate — Erythromycin — Erythromycin Ethyl Succinate — Erythromycin Ethyl Succinate with Water - Purified BP — Erythromycin Lactobionate — Flucloxacillin Magnesium with Water - Purified BP Serious staphylococcal infections Flucloxacillin Sodium In respect of the injection equivalent to 500 mg flucloxacillin, vial (with required solvent) and injection equivalent to 1 g flucloxacillin, vial (with required solvent): — In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin: Serious staphylococcal infections Glucagon Hydrochloride — Glucose — Glyceryl Trinitrate — Hydrocortisone Acetate Treatment of corticosteroid-responsive dermatoses Hydrocortisone Sodium Succinate For use in a hospital Hydromorphone Hydrochloride In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule and injection 50 mg in 5 mL ampoule: — In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL: Severe disabling pain not responding to non-narcotic analgesics Ibuprofen In respect of the tablets 400 mg, 20: — In respect of the tablet 200 mg and tablet 400 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Indomethacin In respect of the suppository 100 mg: — In respect of the capsule 25 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Ketoprofen In respect of the suppository 100 mg: — In respect of the capsule 200 mg (sustained release): Chronic arthropathies (including osteoarthritis) with an inflammatory component Lignocaine Hydrochloride — Lincomycin Hydrochloride — Methylprednisolone Acetate For local intra-articular or peri-articular infiltration Metoclopramide Hydrochloride — Metronidazole In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10: — In respect of the I.V. infusion 500 mg in 100 mL: Treatment, in a hospital, of acute anaerobic sepsis Metronidazole Benzoate — Morphine Hydrochloride Severe disabling pain not responding to non-narcotic analgesics Morphine Sulfate In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule: — In respect of the tablet 30 mg: Severe disabling pain not responding to non-narcotic analgesics In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet: Chronic severe disabling pain not responding to non-narcotic analgesics Naloxone Hydrochloride — Naproxen Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Naproxen Sodium Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Nitrazepam — Nystatin — Oxazepam — Oxycodone Hydrochloride In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL: Severe disabling pain not responding to non-narcotic analgesics In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics Oxycodone Pectinate Severe disabling pain not responding to non-narcotic analgesics Paracetamol — Pethidine Hydrochloride Short-term treatment of acute pain Phenoxymethylpenicillin Benzathine — Phenoxymethylpenicillin Potassium — Piroxicam Chronic arthropathies (including osteoarthritis) with an inflammatory component Procaine Penicillin — Prochlorperazine — Prochlorperazine Maleate — Prochlorperazine Mesylate — Promethazine Hydrochloride — Sodium Chloride — Sodium Chloride with Glucose — Sulindac Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease Temazepam — Tetanus Vaccine - Adsorbed — Tetracycline Hydrochloride (buffered) — Ticarcillin Sodium with Potassium Clavulanate Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Tramadol Hydrochloride In respect of the capsule 50 mg: For acute pain where aspirin or paracetamol alone is inappropriate or has failed For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed In respect of the tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL: For pain where aspirin or paracetamol alone is inappropriate or has failed In respect of the injection 100 mg in 2 mL ampoule: Short-term treatment of acute pain Triamcinolone Acetonide For local intra-articular or peri-articular infiltration Keloid Lichen planus hypertrophic Trimethoprim with Sulfamethoxazole — Vancomycin Hydrochloride Prophylaxis of endocarditis in patients hypersensitive to penicillin Water for Injections - sterilised —
Abacavir Sulfate Abacavir Sulfate with Lamivudine and Zidovudine Aluminium Hydroxide - Dried Aluminium Hydroxide - Dried with Magnesium Hydroxide Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide Amiloride Hydrochloride Hydrochlorothiazide with Amiloride Hydrochloride Amoxycillin Trihydrate Amoxycillin Trihydrate with Potassium Clavulanate Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Amoxycillin Trihydrate with Water - Purified BP Aspirin Dipyridamole with Aspirin Atropine Sulfate Diphenoxylate Hydrochloride with Atropine Sulfate Azithromycin Dihydrate Azithromycin Dihydrate with Water - Purified BP Bacitracin Zinc Neomycin Undecenoate with Bacitracin Zinc Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate Benserazide Hydrochloride Levodopa with Benserazide Hydrochloride Betamethasone Acetate Betamethasone Acetate with Betamethasone Sodium Phosphate Betamethasone Sodium Phosphate Betamethasone Acetate with Betamethasone Sodium Phosphate Bisacodyl Docusate Sodium with Bisacodyl Brimonidine Tartrate Brimonidine Tartrate with Timolol Maleate Budesonide Budesonide with Eformoterol Fumarate Dihydrate Calcium Carbonate Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate Calcium Chloride Sodium Chloride with Potassium Chloride and Calcium Chloride Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride Candesartan Cilexetil Candesartan Cilexetil with Hydrochlorothiazide Carbidopa Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone Carbomer 980 Hypromellose with Carbomer 980 Cefaclor Monohydrate Cefaclor Monohydrate with Water - Purified BP Cephalexin Cephalexin with Water - Purified BP Chlorhexidine Gluconate Silver Sulfadiazine with Chlorhexidine Gluconate Codeine Phosphate Codeine Phosphate with Paracetamol Cyproterone Acetate Oestradiol Valerate with Cyproterone Acetate Dexamethasone Sodium Metasulfobenzoate Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin Dextran 70 Hypromellose 2900 with Dextran 70 Hypromellose 4500 with Dextran 70 Diphenoxylate Hydrochloride Diphenoxylate Hydrochloride with Atropine Sulfate Dipyridamole Dipyridamole with Aspirin Docusate Sodium Docusate Sodium with Bisacodyl Dorzolamide Hydrochloride Dorzolamide Hydrochloride with Timolol Maleate Dydrogesterone Oestradiol with Dydrogesterone Eformoterol Fumarate Dihydrate Budesonide with Eformoterol Fumarate Dihydrate Enalapril Maleate Enalapril Maleate with Hydrochlorothiazide Entacapone Levodopa with Carbidopa and Entacapone Eprosartan Mesylate Eprosartan Mesylate with Hydrochlorothiazide Erythromycin Ethyl Succinate Erythromycin Ethyl Succinate with Water - Purified BP Ethinyloestradiol Levonorgestrel with Ethinyloestradiol Norethisterone with Ethinyloestradiol Flucloxacillin Magnesium Flucloxacillin Magnesium with Water - Purified BP Fluticasone Propionate Fluticasone Propionate with Salmeterol Xinafoate Fosinopril Sodium Fosinopril Sodium with Hydrochlorothiazide Framycetin Sulfate Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin Frangula Bark Sterculia with Frangula Bark Glibenclamide Metformin Hydrochloride with Glibenclamide Glucose Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate Sodium Chloride with Glucose Gramicidin Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin Hydrochlorothiazide Candesartan Cilexetil with Hydrochlorothiazide Enalapril Maleate with Hydrochlorothiazide Eprosartan Mesylate with Hydrochlorothiazide Fosinopril Sodium with Hydrochlorothiazide Hydrochlorothiazide with Amiloride Hydrochloride Hydrochlorothiazide with Triamterene Irbesartan with Hydrochlorothiazide Quinapril Hydrochloride with Hydrochlorothiazide Telmisartan with Hydrochlorothiazide Hypromellose Hypromellose with Carbomer 980 Hypromellose 2900 Hypromellose 2900 with Dextran 70 Hypromellose 4500 Hypromellose 4500 with Dextran 70 Indapamide Hemihydrate Perindopril Erbumine with Indapamide Hemihydrate Insulin - Isophane Insulin - Neutral with Insulin - Isophane Insulin - Neutral Insulin - Neutral with Insulin - Isophane Insulin Aspart Insulin Aspart with Insulin Aspart Protamine Suspension Insulin Aspart Protamine Suspension Insulin Aspart with Insulin Aspart Protamine Suspension Insulin Lispro Insulin Lispro with Insulin Lispro Protamine Suspension Insulin Lispro Protamine Suspension Insulin Lispro with Insulin Lispro Protamine Suspension Irbesartan Irbesartan with Hydrochlorothiazide Lamivudine Abacavir Sulfate with Lamivudine and Zidovudine Lamivudine with Zidovudine Levodopa Levodopa with Benserazide Hydrochloride Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone Levonorgestrel Levonorgestrel with Ethinyloestradiol Lopinavir Lopinavir with Ritonavir Macrogol 3350 Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Magnesium Chloride Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride Magnesium Hydroxide Aluminium Hydroxide - Dried with Magnesium Hydroxide Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide Magnesium Trisilicate Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide Medroxyprogesterone Acetate Oestrogens—Conjugated with Medroxyprogesterone Acetate Mestranol Norethisterone with Mestranol Metformin Hydrochloride Metformin Hydrochloride with Glibenclamide Mycophenolate Mofetil Mycophenolate Mofetil with Water - Purified BP Neomycin Sulfate Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin Neomycin Undecenoate Neomycin Undecenoate with Bacitracin Zinc Norethisterone Norethisterone with Ethinyloestradiol Norethisterone with Mestranol Norethisterone Acetate Oestradiol with Norethisterone Acetate Oestradiol Hemihydrate with Norethisterone Acetate Nystatin Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin Oestradiol Oestradiol with Dydrogesterone Oestradiol with Norethisterone Acetate Oestradiol Hemihydrate Oestradiol Hemihydrate with Norethisterone Acetate Oestradiol Valerate Oestradiol Valerate with Cyproterone Acetate Oestrogens—Conjugated Oestrogens—Conjugated with Medroxyprogesterone Acetate Paracetamol Codeine Phosphate with Paracetamol Paraffin - Liquid Paraffin - Soft White with Paraffin - Liquid Paraffin - Soft White Paraffin - Soft White with Paraffin - Liquid Perindopril Erbumine Perindopril Erbumine with Indapamide Hemihydrate Phenylephrine Hydrochloride Prednisolone Acetate with Phenylephrine Hydrochloride Polyethylene Glycol 400 Polyethylene Glycol 400 with Propylene Glycol Polymyxin B Sulfate Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate Potassium Bicarbonate Potassium Chloride with Potassium Bicarbonate Potassium Chloride Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Potassium Chloride with Potassium Bicarbonate Sodium Chloride with Potassium Chloride and Calcium Chloride Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride Potassium Clavulanate Amoxycillin Trihydrate with Potassium Clavulanate Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Ticarcillin Sodium with Potassium Clavulanate Prednisolone Acetate Prednisolone Acetate with Phenylephrine Hydrochloride Propylene Glycol Polyethylene Glycol 400 with Propylene Glycol Quinapril Hydrochloride Quinapril Hydrochloride with Hydrochlorothiazide Ritonavir Lopinavir with Ritonavir Salmeterol Xinafoate Fluticasone Propionate with Salmeterol Xinafoate Silver Sulfadiazine Silver Sulfadiazine with Chlorhexidine Gluconate Sodium Acetate Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride Sodium Acid Citrate Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate Sodium Alginate Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate Sodium Bicarbonate Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate Sodium Chloride Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Sodium Chloride with Glucose Sodium Chloride with Potassium Chloride and Calcium Chloride Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride Sodium Citrate Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate Sodium Gluconate Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride Sodium Lactate Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride Sodium Lauryl Sulfoacetate Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate Sorbitol Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate Stavudine Stavudine with Water - Purified BP Sterculia Sterculia with Frangula Bark Sulfamethoxazole Trimethoprim with Sulfamethoxazole Telmisartan Telmisartan with Hydrochlorothiazide Testosterone Decanoate Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Isocaproate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Phenylpropionate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Propionate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Ticarcillin Sodium Ticarcillin Sodium with Potassium Clavulanate Timolol Maleate Brimonidine Tartrate with Timolol Maleate Dorzolamide Hydrochloride with Timolol Maleate Triamcinolone Acetonide Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin Triamterene Hydrochlorothiazide with Triamterene Trimethoprim Trimethoprim with Sulfamethoxazole Water - Purified BP Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Amoxycillin Trihydrate with Water - Purified BP Azithromycin Dihydrate with Water - Purified BP Cefaclor Monohydrate with Water - Purified BP Cephalexin with Water - Purified BP Erythromycin Ethyl Succinate with Water - Purified BP Flucloxacillin Magnesium with Water - Purified BP Mycophenolate Mofetil with Water - Purified BP Stavudine with Water - Purified BP Zidovudine Abacavir Sulfate with Lamivudine and Zidovudine Lamivudine with Zidovudine
Acacia BP, powdered —
Acetic Acid (33 per cent) BP —
Alum BP —
Aluminium Acetate Solution BP —
Ammonia Spirit, Aromatic BP —
Aqueous Cream APF For use only as a base combined with active ingredients
Ascorbic Acid BP Use as ingredient of Ferrous Sulfate Mixture APF and Ferrous Sulfate
Mixture CF APF 13
Aspirin BP —
Belladonna Tincture BP —
Benzocaine BP —
Benzoic Acid BP —
Benzoin Tincture, Compound BP —
Calcium Hydroxide BP —
Cetomacrogol Cream, Aqueous APF For use only as a base combined with active ingredients
Cetostearyl Alcohol BP —
Cetrimide Cream, Aqueous APF For use only as a base combined with active ingredients
Chlorhexidine Cream, Aqueous APF For use only as a base combined with active ingredients
Chlorinated Lime BP —
Citric Acid Monohydrate BP —
Coal Tar BP —
Coal Tar Solution BP —
Cocaine Hydrochloride BP —
Coconut Oil BP —
Codeine Phosphate BP May only be prescribed in linctuses, mixtures and mixtures for children
Collodion, Flexible BP —
Dithranol BP —
Emulsifying Ointment BP For use only as a base combined with active ingredients
Ephedrine Hydrochloride BP May only be prescribed in nasal instillations
Ferrous Sulfate BP —
Formaldehyde Solution BP —
Gentian Infusion, Compound, Concentrated BP —
Glycerol BP —
Hydrochloric Acid, Dilute BP —
Iodine BP —
Ipecacuanha Tincture BP —
Kaolin, Light BP —
Kaolin, Light (Natural) BP —
Lactic Acid BP —
Lavender Oil, Spike BPC 1968 —
Levomenthol BP —
Liquorice Liquid Extract BP —
Magnesium Carbonate, Light BP —
Magnesium Sulfate BP May only be prescribed for other than oral use
Magnesium Trisilicate BP —
Menthol, Racemic BP —
Methyl Hydroxybenzoate BP —
Opium Tincture BP —
Orange Tincture BP —
Paraffin, Hard BP —
Paraffin, Light Liquid BP —
Paraffin, Liquid BP May only be prescribed for other than oral use
Paraffin Ointment (white) BP For use only as a base combined with active ingredients
Paraffin Ointment (yellow) BP 1968 For use only as a base combined with active ingredients
Paraffin, Soft White BP —
Paraffin, Soft Yellow BP —
Phenobarbitone Sodium BP May only be prescribed for the treatment of epilepsy
Phenol, Liquefied BP Not available for ear drops
Podophyllum Resin BP —
Potassium Citrate BP —
Potassium Iodide BP —
Potassium Permanganate BP —
Propylene Glycol BP —
Propyl Hydroxybenzoate BP —
Red Syrup APF 15 —
Resorcinol BP —
Salicylic Acid BP —
Simple Ointment (white) BP For use only as a base combined with active ingredients
Simple Ointment (yellow) BP For use only as a base combined with active ingredients
Sodium Bicarbonate BP —
Sodium Chloride BP —
Sodium Citrate BP —
Starches BP —
Sulfur, Precipitated BP 1980 —
Syrup BP —
Talc, Purified BP, sterilised —
Thymol BP —
Thymol Mouth Wash, Compound APF 15 —
Tragacanth BP, powdered —
Tragacanth Powder, Compound BP 1980 —
Trichloroacetic Acid BP 1980 —
Triethanolamine BP —
Water for Injections, sterilised BP May only be prescribed in eye drops and eye lotions
Water, Purified BP —
Wool Alcohols Ointment (white) BP For use only as a base combined with active ingredients
Wool Alcohols Ointment (yellow) BP For use only as a base combined with active ingredients
Wool Fat BP —
Wool Fat, Hydrous BP —
Zinc Cream BP For use only as a base combined with active ingredients
Zinc Oxide BP —
Zinc Sulfate BP —
SCHEDULE 5 — ADDITIVES
Acetone BP
Anise Water, Concentrated BP
Boric Acid BP
Castor Oil BP
Chlorhexidine Acetate BP
Chloroform BP
Ethanol (96 per cent) BP
Ethanols, Dilute BP
Ether, Solvent BP
Eucalyptus Oil BP
Honey, Purified BP 1993
Industrial Methylated Spirit BP
Olive Oil BP
Peppermint Oil BP
Peppermint Water, Concentrated APF
Pholcodine Citrate Syrup BPC 1959
Sodium Thiosulfate BP
Abacavir Sulfate Abacavir Sulfate with Lamivudine and Zidovudine Adefovir Dipivoxil Amprenavir Apomorphine Hydrochloride Atazanavir Sulfate Bosentan Monohydrate Botulinum Toxin Type A Purified Neurotoxin Complex Buprenorphine Hydrochloride Charcoal - Activated Cidofovir Clostridium Botulinum Type A Toxin—Haemagglutinin Complex Clozapine Darbepoetin Alfa Deferiprone Delavirdine Mesylate Desferrioxamine Mesylate Didanosine Dornase Alfa Efavirenz Emtricitabine Enfuvirtide Epoetin Alfa Filgrastim Fosamprenavir Calcium Foscarnet Sodium Ganciclovir Ganciclovir Sodium Iloprost Trometamol Imatinib Mesylate Indinavir Sulfate Infliximab Interferon Gamma-1b Lamivudine Lamivudine with Zidovudine Lanreotide Acetate Lenograstim Lopinavir with Ritonavir Nelfinavir Mesylate Nevirapine Octreotide Octreotide Acetate Pegfilgrastim Peginterferon Alfa-2a Peginterferon Alfa-2b Progesterone Ribavirin and Peginterferon Alfa-2a Ribavirin and Peginterferon Alfa-2b Rifabutin Ritonavir Saquinavir Saquinavir Mesylate Somatropin Stavudine Stavudine with Water - Purified BP Tenofovir Disoproxil Fumarate Valganciclovir Hydrochloride Zalcitabine Zidovudine Zoledronic Acid Dated this sixteenth day of September 2005.
JOAN CORBETT
Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
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