National Health Act 1953 Declaration under subsections 85(2) and 85(2AA) Determinations under subsection 85(2A) (No. PB 88 of 2007) (Cth)

Declaration and Determination — drugs and medicinal preparations (PB 88 of 2007)

as amended

made under subsections 85(2), 85(2A) and 85(2AA) of the

National Health Act 1953

This compilation was prepared on 1 July 2008
taking into account amendments up to PB 59 of 2008

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Declaration and determination — drugs and medicinal preparations
(PB 88 of 2007

Commencement [see Note 1]

1. This instrument commences on 1 December 2007.

Repeal

2. Instrument number PB 48 of 2007 is repealed.

Definitions

3. In this instrument:

“Act” means the National Health Act 1953;

“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;

“Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;

“PBS” means Pharmaceutical Benefits Scheme;

“palliative care patient”, in relation to a circumstance specified in Schedule 1A, means a patient with an active, progressive, far‑advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;

“ready‑prepared pharmaceutical benefit” means a pharmaceutical item 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.

Drugs and medicinal preparations to which Part VII applies

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 3 of Schedule 1 or column 2 of Schedule 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.

4B. 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 2A and the circumstances (if any) specified in column 2 of Schedule 2A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised optometrist.

5. A medicinal preparation composed of a compound that includes a drug or medicinal preparation 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 drug or medicinal preparation, is not a medicinal preparation to which Part VII of the Act applies, unless the name of that drug or medicinal preparation 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 drug or medicinal preparation composed of a compound that includes a ready‑prepared pharmaceutical benefit, other than 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.

Circumstances

12. Where circumstances are specified in column 3 of Schedule 1 or column 2 of Schedule 1A, 2, 2A or 4 for a listed drug specified in column 1 of any of those Schedules, a pharmaceutical benefit that has the listed drug (in the form if any mentioned in column 3 or 2 respectively) 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 for a drug or medicinal preparation specified in column 1 of that Schedule, an extemporaneously prepared pharmaceutical benefit that contains the drug or medicinal preparation as an ingredient is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

14. Subject to paragraph 16, the following circumstances are determined in relation to each relevant pharmaceutical benefit for the purposes of section 85(2A)(b) of the Act:

(a) where a class of persons is specified in column 3 of Schedule 1 or column 2 of Schedule 1A, 2, 2A 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 3 of Schedule 1 or column 2 of Schedule 1A, 2, 2A 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 3 of Schedule 1 or column 2 of Schedule 1A, 2, 2A or 4 — that the pharmaceutical benefit is to be supplied for that purpose;

(d) where it is specified in column 3 of Schedule 1 or column 2 of Schedule 1A (in respect of medical practitioners), or in column 2 of Schedule 2A (in respect of authorised optometrists), that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner or authorised optometrist has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:

(i) by delivering or posting to the Medicare Australia CEO the prescription prepared and signed by the medical practitioner or authorised optometrist:

(A) in a form approved by the Secretary and completed by the medical practitioner or authorised optometrist in ink in his or her own handwriting; or

(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or

(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

(D) by a method approved in writing by the Secretary; or

(ii) by submitting the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner or authorised optometrist in accordance with subsubparagraph (i); or

(iii) where the medical practitioner or authorised optometrist has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner or authorised optometrist by the Medicare Australia CEO; or

(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).

14A. For the purposes of subsubparagraph 14(d)(i), a prescription that has been prepared and signed by the medical practitioner or authorised optometrist 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 Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i) if the Medicare Australia CEO requires the medical practitioner or authorised optometrist to alter the prescription — by returning it to the medical practitioner or authorised optometrist for alteration before the medical practitioner or authorised optometrist 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 authorised optometrist; 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 Medicare Australia CEO is given details of the prescription; or

(c) if the prescription was submitted in accordance with subsubparagraph 14(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.

15A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 15(b) or (c):

(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; or in the case of an authorised optometrist, must tell the optometrist orally the number that has been allotted to the authorised prescription; and

(b) the medical practitioner or authorised optometrist 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 or authorised optometrist of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner or authorised optometrist by the Medicare Australia CEO.

15C. If a medical practitioner has written on a prescription, that has been prepared and signed in accordance with subsubparagraph 14(d)(i), the streamlined authority code mentioned in Schedule 1 for a pharmaceutical benefit and circumstances:

(a) subparagraph 14(d) is taken to have been complied with; and

(b) the Medicare Australia CEO is taken to have authorised the prescription.

15D. Paragraph 15C applies to a prescription only if there is a streamlined authority code for the pharmaceutical benefit and circumstances in Schedule 1.

16. Where the circumstances "For use in accordance with paragraph 16" are specified in column 3 of Schedule 1, the circumstances specified for the purpose of subparagraph 14(c) are:

(a) that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient identified as being in one of the following very high risk categories:

(i) coronary heart disease which has become symptomatic;

(ii) cerebrovascular disease which has become symptomatic;

(iii) peripheral vascular disease which has become symptomatic;

(iv) diabetes mellitus with microalbuminuria (defined as urinary albumin excretion rate of greater than 20 micrograms per minute, or urinary albumin to creatinine ratio of greater than 2.5 for males or greater than 3.5 for females);

(v) diabetes mellitus in Aboriginal or Torres Strait Islander patients;

(vi) diabetes mellitus in patients aged 60 years or more;

(vii) family history of coronary heart disease which has become symptomatic before the age of 55 years in two or more first degree relatives;

(viii) family history of coronary heart disease which has become symptomatic before the age of 45 years in one or more first degree relatives; or

(b) if subparagraph 16(a) does not apply — that the pharmaceutical benefit is to be supplied for the treatment, in conjunction with dietary therapy, of a patient who, after at least 6 weeks of dietary therapy, qualifies for the supply of the benefit in accordance with the following table:

Category of patient	Fasting lipid level
Patients with diabetes mellitus not otherwise included	total cholesterol greater than 5.5 mmol per L
Aboriginal or Torres Strait Islander patients; Patients with hypertension	total cholesterol greater than 6.5 mmol per L; or total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L
Patients with high density lipoprotein cholesterol less than 1 mmol per L	total cholesterol greater than 6.5 mmol per L
Patients with familial hypercholesterolaemia identified by: (1) DNA mutation; or (2) tendon xanthomas in the patient or their first or second degree relative Patients with: (1) family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or (2) family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives	If aged 18 years or less at treatment initiation: low density lipoprotein cholesterol greater than 4 mmol per L If aged more than 18 years at treatment initiation: low density lipoprotein cholesterol greater than 5 mmol per L; or total cholesterol greater than 6.5 mmol per L; or total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L
Patients not eligible under the above: (1) men over 34 but less than 76 years of age; or (2) post‑menopausal women less than 76 years of age	total cholesterol greater than 7.5 mmol per L; or triglyceride greater than 4 mmol per L
Patients not otherwise included	total cholesterol greater than 9 mmol per L; or triglyceride greater than 8 mmol per L

Abciximab	In compliance with authority procedures set out in subparagraph 14 (d):
1716		Patients undergoing percutaneous coronary balloon angioplasty
1717		Patients undergoing percutaneous coronary atherectomy
1718		Patients undergoing percutaneous coronary stent placement
Acamprosate	In compliance with authority procedures set out in subparagraph 14 (d):
2665		For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence
Acarbose	—
Acetazolamide	—
Acetylcysteine	Bronchiectasis
Cystic fibrosis
Aciclovir	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) but where commencement of treatment need not await confirmation of diagnosis
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)
In respect of the eye ointment 30 mg per g, 4.5 g: Herpes simplex keratitis
Acitretin	In compliance with authority procedures set out in subparagraph 14 (d):
1366		Severe intractable psoriasis
1363		Severe forms of disorders of keratinisation
Adalimumab	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months’ treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 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, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and
(c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient’s response to their most recent course of PBS-subsidised adalimumab therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
(b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 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 a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and
(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
(5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
(3) have not failed treatment with adalimumab during the current Treatment Cycle; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) were receiving treatment with adalimumab prior to 16 March 2006; and
(3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;
the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the application for authorisation includes:
(a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
the application is accompanied by the results of the patient’s most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and
(a) who is receiving treatment with adalimumab at the time of application; and
(b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and
(c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and
(d) who has:
(i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and
(e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application;
the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form;
the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
where the following conditions apply:
a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L;
all measurements provided are no more than 1 month old at the time of application;
the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
(b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;
the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Adrenaline	In respect of the injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000): —
In respect of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector: 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
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis
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
Albendazole	In respect of the tablet 200 mg: In compliance with authority procedures set out in subparagraph 14 (d):
2446		Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person
1525		Treatment of tapeworm infestation
In respect of the tablet 400 mg: In compliance with authority procedures set out in subparagraph 14 (d):
1496		For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used
Alendronic Acid	In respect of the tablet 70 mg (as alendronate sodium): In compliance with authority procedures set out in subparagraph 14 (d):
2645		Treatment as the sole PBS‑subsidised anti‑resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T‑score of ‑3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated
2646		Treatment as the sole PBS‑subsidised anti‑resorptive agent 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 documented in the patient’s medical records when treatment is initiated, 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
In respect of the tablet 40 mg (as alendronate sodium): In compliance with authority procedures set out in subparagraph 14 (d):
1392		Symptomatic Paget’s disease of bone
Alendronic Acid with Colecalciferol	In compliance with authority procedures set out in subparagraph 14 (d):
2645		Treatment as the sole PBS‑subsidised anti‑resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T‑score of ‑3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated
2646		Treatment as the sole PBS‑subsidised anti‑resorptive agent 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 documented in the patient’s medical records when treatment is initiated, 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
Alginic acid with calcium carbonate and sodium bicarbonate	—
Allopurinol	—
Alprazolam	In compliance with authority procedures set out in subparagraph 14 (d):
Panic disorder where other treatments have failed or are inappropriate
Aluminium Hydroxide with Magnesium Hydroxide	—
Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide	—
Amantadine	Parkinson’s disease which is not drug induced
Amiloride	—
Amino acid formula without methionine, threonine and valine and low in isoleucine	Methylmalonic acidaemia Propionic acidaemia
Amino acid formula without phenylalanine	Phenylketonuria
Amino acid formula without phenylalanine, and vitamins with minerals	Phenylketonuria
Amino acid formula without phenylalanine, tyrosine and methionine	Tyrosinaemia
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine	Phenylketonuria
Amino acid formula with vitamins and minerals without lysine and low in tryptophan	In respect of the oral powder 400 g (XLYS, LOW TRY Analog): An infant or young child with proven glutaric aciduria type 1
In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid): A child aged less than 7 years with proven glutaric aciduria type 1
Amino acid formula with vitamins and minerals without methionine	In respect of the oral powder 400 g (XMET Analog): For infants and very young children with pyridoxine non‑responsive homocystinuria
In respect of the sachets containing oral powder 20 g, 30 (HCU gel), sachets containing oral powder 25 g, 30 (HCU express), oral powder 500 g (XMET Maxamaid), oral powder 500 g (XMET Maxamum) and oral liquid 130 mL, 30 (HCU Cooler): Pyridoxine non‑responsive homocystinuria
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine	Methylmalonic acidaemia Propionic acidaemia
Amino acid formula with vitamins and minerals without phenylalanine	Phenylketonuria
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Tyrosinaemia
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Maple syrup urine disease
Amino acids — synthetic, formula	In respect of the oral powder 400 g (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 a child 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
Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, 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 a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application
Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:
eosinophilic oesophagitis is demonstrated by the following criteria:
(i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the date of birth of the patient is included in the authority application;
treatment with oral steroids is not commenced during the period of initial treatment
Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where: response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment
In respect of the oral powder 400 g (Neocate), oral powder 400 g (Neocate Advance) and oral powder 400 g (Neocate Advance Tropical Flavour): 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 a child 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
Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, 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 a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application
Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids	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 a child 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

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, 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 a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application
Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Aminoglutethimide	—
Amiodarone	Severe cardiac arrhythmias
Amisulpride	In compliance with authority procedures set out in subparagraph 14 (d):
1589		Schizophrenia
Amitriptyline	—
Amlodipine	—
Amlodipine with Atorvastatin	For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are currently receiving treatment with a dihydropyridine calcium channel blocker
For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti‑anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate
For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are intolerant of the side effects of other classes of antihypertensive and/or anti‑anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate
Amoxycillin	In respect of the tablet, chewable, 250 mg (as trihydrate), capsule 250 mg (as trihydrate), capsule 500 mg (as trihydrate), sachet containing oral powder 3 g (as trihydrate), powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL, powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL, powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL and powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL: —
In respect of the tablet 1 g (as trihydrate): Acute exacerbations of chronic bronchitis
Amoxycillin with Clavulanic Acid	Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amphotericin	—
Ampicillin	—
Anakinra	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months’ treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
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 (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 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, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with anakinra within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and
(c) have not failed previous PBS-subsidised treatment with anakinra during this Treatment Cycle; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised anakinra treatment; and
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with anakinra are not eligible to commence treatment with anakinra until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with anakinra in this Treatment Cycle, evidence of the patient’s response to their most recent course of PBS-subsidised anakinra therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with anakinra within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment with anakinra within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with anakinra; and
(c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with anakinra; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
(b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of anakinra therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
the patient has not failed to demonstrate response to a course of PBS-subsidised anakinra in this Treatment Cycle;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 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 a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Anastrozole	Treatment of hormone‑dependent breast cancer in post‑menopausal women
Anecortave	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age‑related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS‑subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) ‑ PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic
In compliance with authority procedures set out in subsubparagraph 14 (d) (ii): Initial treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age‑related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS‑subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) ‑ PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic, is submitted to the Medicare Australia CEO by facsimile prior to contact by telephone and is resubmitted to the Medicare Australia CEO by post after the application has been authorised
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation due to age‑related macular degeneration, where the patient has previously been granted at least 1, but not more than 9, authority prescriptions for anecortave acetate for treatment of the same eye
Apraclonidine	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;
streptozocin
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer where cyclophosphamide and an anthracycline are to be co‑administered, when aprepitant is used in combination with a 5‑hydroxytryptamine type 3 receptor antagonist and dexamethasone, and 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
Aripiprazole	In compliance with authority procedures set out in subparagraph 14 (d):
1589			Schizophrenia
Aspirin	—
Atenolol	—
Atomoxetine	In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‑IV) criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride poses an unacceptable medical risk due to the following contraindications as specified in the Therapeutic Goods Administration‑approved Product Information:
(1) the patient has a history of substance abuse or misuse (other than alcohol); and/or
(2) the patient has comorbid motor tics or Tourette’s Syndrome; and/or
(3) the patient has comorbid severe anxiety diagnosed according to the DSM‑IV
Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM‑IV criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride has resulted in the development or worsening of a comorbid mood disorder (that is, anxiety disorder, obsessive compulsive disorder or depressive disorder, diagnosed according to the DSM‑IV criteria) of a severity necessitating permanent stimulant treatment withdrawal, or where the combination of stimulant treatment with another agent would pose an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal
Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM‑IV criteria, where treatment with dexamphetamine sulfate and methylphenidate hydrochloride has resulted in the development of adverse reactions of a severity necessitating permanent treatment withdrawal:
(1) Adverse effects on growth and weight; and/or
(2) Adverse effects on sleep including insomnia; and/or
(3) Adverse effects on appetite including anorexia
Continuing treatment where the patient has previously been issued with an authority prescription for this drug
Atorvastatin	For use in accordance with paragraph 16
Atovaquone	In compliance with authority procedures set out in subparagraph 14 (d):
1433			Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy
Atropine	—
Auranofin	—
Aurothiomalate	—
Azathioprine	—
Azithromycin	In respect of the tablet 500 mg (as dihydrate): Uncomplicated urethritis due to Chlamydia trachomatis
Uncomplicated cervicitis due to Chlamydia trachomatis
Trachoma
In respect of the powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL: Trachoma
Baclofen	—
Balsalazide	In compliance with authority procedures set out in subparagraph 14 (d):
1708			Ulcerative colitis where hypersensitivity to sulfonamides exists
1709			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	In respect of the pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) and pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation): —
In respect of the pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) and pressurised inhalation in breath actuated device containing beclomethasone dipropionate 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 benzylpenicillin	—
Benzathine Penicillin	—
Benzhexol	—
Benztropine	—
Benzydamine	Radiation induced mucositis
Benzylpenicillin	—
Betamethasone	In respect of the injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL: 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
In respect of the cream 500 micrograms (as dipropionate) per g, 15 g, cream 200 micrograms (as valerate) per g, 100 g, ointment 500 micrograms (as dipropionate) per g, 15 g, cream 500 micrograms (as valerate) per g, 15 g, ointment 200 micrograms (as valerate) per g, 100 g and ointment 500 micrograms (as valerate) per g, 15 g: Treatment of corticosteroid‑responsive dermatoses
Betaxolol	—
Bethanechol	—
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
Bifonazole	In compliance with authority procedures set out in subparagraph 14 (d):
2354			Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Bimatoprost	—
Biperiden	—
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	In compliance with authority procedures set out in subparagraph 14 (d):
1734			Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin‑converting enzyme inhibitor if tolerated
Bivalirudin	In compliance with authority procedures set out in subparagraph 14 (d):
2147			Patients undergoing non‑emergency percutaneous coronary intervention
Bleomycin	Germ cell neoplasms
Lymphoma
Bortezomib	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; and
where the following conditions apply:
if serum M protein and urine Bence‑Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24‑hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence‑Jones protein levels are unmeasurable as in non‑secretory/oligo‑secretory multiple myeloma, partial response compared with baseline is defined as:
(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value;
if serum M protein and urine Bence‑Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or
(f) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(g) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS‑subsidised bortezomib treatment beyond 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorisation of further treatment;
a patient will be deemed to have failed to respond to 8 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 9;
the authority application is made not later than 10 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved;
PBS‑subsidised treatment with bortezomib is limited to a maximum of 11 cycles
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS‑subsidised treatment of multiple myeloma in patients receiving treatment with bortezomib prior to 1 November 2007; and
where the following conditions apply:
patients who fail to demonstrate at least a partial response after 4 cycles are not eligible to receive further PBS‑subsidised treatment with bortezomib;
patients who qualify for PBS‑subsidised treatment under this restriction may receive a maximum of 3 cycles, after which the patient must qualify under the continuing treatment criteria to receive further treatment;
the authority application includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and
(2) a signed patient acknowledgment; and
(3) details including relevant reports of the basis of the diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and
(4) if relevant, details including relevant reports for patients who have demonstrated a partial response and who have received 4 or more cycles;
diagnostic reports demonstrating at least a partial response are within 1 month of the date of application
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and
where the following conditions apply:
if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;
thalidomide treatment failure is defined as:
(1) confirmed disease progression during or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;
progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(d) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(e) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(f) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);
severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;
toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug‑related seizures, serious Grade 3 or Grade 4 drug‑related dermatological reactions, such as Stevens‑Johnson Syndrome, or other Grade 3 or 4 toxicity;
the authority application includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form, which includes details of prior treatments including names of drugs and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; the patient’s WHO performance status; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease; nomination of which disease activity parameters will be used to assess response; and the results of current diagnostic reports as detailed below; and
(2) duration of thalidomide and daily dose prescribed; and
(3) a signed patient acknowledgment;
to enable the Medicare Australia CEO to confirm response, current diagnostic reports of the following are required to establish baseline:
(a) the level of serum M protein (monoclonal protein); and
(b) if Bence‑Jones proteinuria is present, the results of 24‑hour urinary light chain M protein excretion;
if neither serum M protein nor urine Bence‑Jones protein is present in measurable quantities, additional diagnostic reports are required, including:
(c) bone marrow aspirate and trephine; and
(d) if present, the size and location of lytic bone lesions (not including compression fractures); or
(e) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or
(f) if present, the level of hypercalcaemia, corrected for albumin concentration; or
(g) if present, the serum free light chain levels;
to enable assessment of response, baseline values for the above parameters must be provided with the authority application as follows:
(i) for all patients, results for (a) and (b) must be provided;
(ii) where the patient has oligo‑secretory or non‑secretory multiple myeloma, results for (c) and if relevant (d), (e) or (f) must be provided;
(iii) where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, results for (g) must be provided;
where baseline values for 1 or more of the specified parameters cannot be provided, the authority application states the reason or reasons these cannot be provided
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and
where the following conditions apply:
if serum M protein and urine Bence‑Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24‑hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence‑Jones protein levels are unmeasurable as in non‑secretory/oligo‑secretory multiple myeloma, partial response compared with baseline is defined as:

(c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels;
if serum M protein and urine Bence‑Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or
(f) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(g) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS‑subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment;
a patient will be deemed to have failed to respond to 4 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 5;
the authority application is made not later than 6 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS‑subsidised treatment with bortezomib;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved
Brimonidine	—
Brimonidine with Timolol	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	In respect of the tablet 2.5 mg (as mesylate): 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 5 mg (as mesylate) and capsule 10 mg (as mesylate): Acromegaly
Parkinson’s disease
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Budesonide	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):
1351			Severe chronic asthma in patients who require long‑term steroid therapy and who are unable to use other forms of inhaled steroid therapy
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: —
Budesonide with Eformoterol	In respect of the powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses and powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses: 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
For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with oral corticosteroids
For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with inhaled corticosteroids
For maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and a long‑acting beta‑2 agonist
In respect of the powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2: 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
Buprenorphine	Chronic severe disabling pain not responding to non‑narcotic analgesics
Bupropion	In compliance with authority procedures set out in subparagraph 14 (d):
Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application
Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is 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 short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program
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):
2659		Pathological hyperprolactinaemia where surgery is not indicated
2660		Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
2661		Pathological hyperprolactinaemia where radiotherapy is not indicated
2662		Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg: Parkinson’s disease
Calcipotriol	In respect of the ointment 50 micrograms per g, 30g and cream 50 micrograms (as monohydrate) per g, 30 g Chronic stable plaque type psoriasis vulgaris In respect of the scalp solution 50 micrograms (as monohydrate) per mL, 30 mL: Chronic stable plaque type psoriasis vulgaris of the scalp
Calcitriol	In compliance with authority procedures set out in subparagraph 14 (d):
1165		Hypocalcaemia due to renal disease
1166		Hypoparathyroidism
1167		Hypophosphataemic rickets
1467		Vitamin D‑resistant rickets
2636		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 documented in the patient’s medical records when treatment is initiated, 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
Calcium	In compliance with authority procedures set out in subparagraph 14 (d):
2212		Hyperphosphataemia associated with chronic renal failure
Candesartan	—
Candesartan 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
Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour
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
Carbamazepine	—
Carbimazole	—
Carbohydrate, fat, vitamins, minerals and trace elements	Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
Carbomer 974	In compliance with authority procedures set out in subparagraph 14 (d):
1359		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):
1359		Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops
Carboplatin	—
Carmellose	In respect of the eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30, eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d):
1359		Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops
Carmustine	Glioblastoma multiforme, suspected or confirmed, at the time of initial surgery
Carvedilol	In compliance with authority procedures set out in subparagraph 14 (d):
1734		Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin‑converting enzyme inhibitor if tolerated
1735		Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002
Cefaclor	—
Cefepime	In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of febrile neutropenia
Cefotaxime	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Ceftriaxone	In respect of the powder for injection 500 mg (as sodium): Gonorrhoea
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
In respect of the powder for injection 1 g (as sodium) and powder for injection 2 g (as sodium): Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Cefuroxime	—
Celecoxib	Symptomatic treatment of osteoarthritis
Symptomatic treatment of rheumatoid arthritis
Cephalexin	—
Cephalothin	—
Cephazolin	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Cetuximab	In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration‑approved Product Information
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Chlorambucil	—
Chloramphenicol	—
Chlorpromazine	—
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	—
Cinacalcet	In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy, following initiation and stabilisation of treatment with cinacalcet, of a patient with chronic kidney disease on dialysis who has a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment
Ciprofloxacin	In respect of the tablet 500 mg (as hydrochloride) and tablet 750 mg (as hydrochloride): 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 250 mg (as hydrochloride): 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 ear drops 3 mg (as hydrochloride) per mL, 5 mL: In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older
In respect of the eye drops 3 mg (as hydrochloride) per mL, 5 mL: In compliance with authority procedures set out in subparagraph 14 (d):
Bacterial keratitis
Cisplatin	—
Citalopram	Major depressive disorders
Cladribine	In compliance with authority procedures set out in subparagraph 14 (d):
Hairy cell leukaemia
Clarithromycin	—
Clindamycin	Gram‑positive coccal infections where these cannot be safely and effectively treated with a penicillin
Clodronic Acid	Maintenance treatment of hypercalcaemia of malignancy refractory to anti‑neoplastic therapy
Multiple myeloma
Bone metastases from breast cancer
Clomiphene	Anovulatory infertility
Patients undergoing in‑vitro fertilisation
Clomipramine	Cataplexy associated with narcolepsy
Obsessive‑compulsive disorder
Phobic disorders in adults
Clonazepam	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
In respect of the injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent): Epilepsy
Clonidine	—
Clopidogrel	In compliance with authority procedures set out in subparagraph 14 (d):
1719		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
1720		Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low‑dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1721		Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events 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
1722		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
1723		Prevention of recurrence of myocardial infarction or unstable angina in patients where low‑dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1724		Prevention of recurrence of myocardial infarction or unstable angina 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
Clotrimazole	In compliance with authority procedures set out in subparagraph 14 (d):
2354		Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Coal Tar ‑ Prepared	—
Codeine	—
Codeine with Paracetamol	—
Colchicine	—
Colestipol	—
Copper Sulfate	—
Cortisone	—
Cromoglycic Acid	In respect of the capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic), pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses, pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC‑free formulation) and pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC‑free formulation): —
In respect of the eye drops containing sodium cromoglycate 20 mg per mL, 10 mL: Vernal kerato‑conjunctivitis
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
Management (which includes initiation, stabilisation and review of therapy) by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate
Management (which includes initiation, stabilisation and review of therapy) by dermatologists 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
Management (which includes initiation, stabilisation and review of therapy) by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow‑acting anti‑rheumatic agents (including methotrexate) are ineffective or inappropriate
Cyproheptadine	Prevention of migraine
Cyproterone	In respect of the tablet containing cyproterone acetate 50 mg: In compliance with authority procedures set out in subparagraph 14 (d):
1230		Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non‑pregnant women
1014		Advanced carcinoma of the prostate
1404		To reduce drive in sexual deviations in males
In respect of the tablet containing cyproterone acetate 100 mg: In compliance with authority procedures set out in subparagraph 14 (d):
1014		Advanced carcinoma of the prostate
1404		To reduce drive in sexual deviations in males
Cystine with carbohydrate	Pyridoxine non-responsive homocystinuria
Cytarabine	—
Dalteparin	—
Danazol	In compliance with authority procedures set out in subparagraph 14 (d):
1090		Endometriosis, visually proven
1151		Hereditary angio‑oedema
2639		Treatment, for up to 6 months, of intractable primary menorrhagia
2640		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	Treatment of chronic spasticity
Dapsone	—
Dasatinib	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL, who has failed treatment with chemotherapy and imatinib, and, where appropriate, allogeneic haemopoietic stem cell transplantation; and
where failure of treatment is defined as either:
(i) failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months of treatment with intensive chemotherapy and imatinib;
(ii) morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;
(iii) morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation; and
where the following conditions apply:
the patient has active leukaemia, as defined by the presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; or the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission;
the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, along with the date of the relevant report or reports
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL, who has been treated prior to 1 December 2007 and has failed treatment with chemotherapy and, where appropriate, allogeneic haemopoietic stem cell transplantation; and
where the following conditions apply:
the patient has active leukaemia, as defined by the presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; or the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission;
the authority application includes:
(a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, along with the date of the relevant report or reports
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment, as monotherapy, of a patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL, where the patient has previously been issued with an authority prescription for dasatinib for ALL and does not have progressive disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, as the sole PBS‑subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL, and who:
(a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR‑ABL and morphological evidence of leukaemia); and
(b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:
(i) lack of response to initial imatinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR‑ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or
(ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or
(iii) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:
(1) accelerated phase is defined by the presence of 1 or more of the following:
— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
— percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or
— peripheral basophils greater than or equal to 20%; or
— progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
— karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and
(2) blast crisis is defined as either:
— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
— extramedullary involvement other than spleen and liver; or
(iv) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first‑line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or
(v) detection of a mutation in BCR‑ABL (L248V, G250E, Q252H/R, Y253H/F, E255K/V, H396P/R, and D276G) that infers high level imatinib resistance; or
(vi) grade 3 or 4 non‑haematological toxicity that is imatinib related; and
where the authority application includes:
(a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of chronic myeloid leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, and the date of the relevant pathology report; and
(e) a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement or details of Grade 3 or 4 non‑haematological toxicity
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR‑ABL level in the blood, due to dasatinib therapy, in the preceding 12 months; and
where the following conditions apply:
a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;
a bone marrow or peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;
response to PBS‑subsidised treatment with dasatinib is assessed by:
(1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR‑ABL specific probe; or
(2) quantitative PCR indicating the relative level of BCR‑ABL transcript in the peripheral blood using the international scale;
the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:
(i) between 10 and 12 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and
(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been sustained;
the authority application includes:
(1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib Authority Application Form for continuing treatment; and
(2) demonstration of continued response to treatment as evidenced by:
(a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or
(b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR‑ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and
(3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR‑ABL specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis;
a patient who has previously received PBS‑subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS‑subsidised re‑treatment
Desmopressin	In respect of the intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle: In compliance with authority procedures set out in subparagraph 14 (d):
1678		Cranial diabetes insipidus
In respect of the tablet containing desmopressin acetate 200 micrograms and nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL: In compliance with authority procedures set out in subparagraph 14 (d):
2641		Primary nocturnal enuresis in patients aged 6 years or older who are refractory to an enuresis alarm
2642		Primary nocturnal enuresis in patients aged 6 years or older for whom an enuresis alarm is contraindicated, and where the reason for the contraindication is documented in the patient’s medical records when treatment is initiated
1678		Cranial diabetes insipidus
Dexamethasone	—
Dexamethasone with Framycetin and Gramicidin	—
Dexamphetamine	In compliance with authority procedures set out in subparagraph 14 (d):
Use in attention deficit hyperactivity disorder, in accordance with State/Territory law
Narcolepsy
Diazepam	—
Diclofenac	In respect of the tablet (enteric coated) containing diclofenac sodium 25 mg and tablet (enteric coated) containing diclofenac sodium 50 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component

(a) the patient has been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the Medicare Benefits Scheme (MBS) Visudyne Therapy Program and has received no more than 14 such treatments; and
(b) the authority application includes:
(i) a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) – PBS Supporting Information Form which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(ii) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic; and
(c) the authority application is submitted to the Medicare Australia CEO by facsimile prior to contact by telephone and is resubmitted to the Medicare Australia CEO by post after the application has been authorised
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation due to macular degeneration, where:
(a) the patient has previously been granted an authority prescription for verteporfin for treatment of the same eye; and
(b) the patient has previously received no more than 14 subsidised treatments with verteporfin in that eye, treatments administered under the MBS Visudyne Therapy Program and treatments administered under the PBS included; and
(c) a course of treatment abandoned prior to completion of the laser activation step but after infusion of verteporfin is not regarded to be a subsidised treatment for the purposes of (b) above, provided that the Medicare Australia CEO has been notified and advised of the reason for the abandonment
Vigabatrin	In compliance with authority procedures set out in subparagraph 14 (d):
1426		Treatment of epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs
Vinblastine	—
Vincristine	—
Vinorelbine	In respect of the capsule 20 mg (as tartrate) and capsule 30 mg (as tartrate): In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced or metastatic non‑small cell lung cancer
In respect of the solution for I.V. infusion 10 mg (as tartrate) in 1 Ml and solution for I.V. infusion 50 mg (as tartrate) in 5 Ml: In compliance with authority procedures set out in subparagraph 14 (d):
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Locally advanced or metastatic non‑small cell lung cancer
Warfarin	—
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose	In compliance with authority procedures set out in subparagraph 14 (d):
Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet
Ziprasidone	In compliance with authority procedures set out in subparagraph 14 (d):
1589		Schizophrenia
Zolmitriptan	In compliance with authority procedures set out in subparagraph 14 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS‑listed drugs
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS‑listed drugs
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS‑listed drugs
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences
Zuclopenthixol Decanoate	—

Benzydamine	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where a painful mouth is a problem
Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem
Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred
Bisacodyl	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Carmellose	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where dry mouth is a symptom
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Clonazepam	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients for the prevention of epilepsy
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Diazepam	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where anxiety is a problem
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Diclofenac	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Fentanyl	In compliance with authority procedures set out in subparagraph 14 (d):
Initial supply for dose titration for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects
First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects
Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred
Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects
Glycerol	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Hyoscine	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where colicky pain is a symptom
Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom
Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred
Ibuprofen	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Indomethacin	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Lactulose	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Macrogol 3350	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where constipation is a problem
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Methadone	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply, for up to 1 month, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics
Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Morphine	In respect of the tablet containing morphine sulfate 10 mg and tablet containing morphine sulfate 20 mg: In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply, for up to 1 month, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics
Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
In respect of the tablet containing morphine sulfate 200 mg (controlled release): In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply, for up to 1 month, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics
Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Naproxen	In respect of the tablet containing naproxen sodium 550 mg, tablet 250 mg, tablet 500 mg, tablet 750 mg (sustained release) and tablet 1 g (sustained release): In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
In respect of the oral suspension 125 mg per 5 Ml, 474 Ml: In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent
Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent, and where consultation with a palliative care specialist or service has occurred
Nitrazepam	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where insomnia is a problem
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Oxazepam	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where anxiety is a problem
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
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
Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
Promethazine	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where nausea and/or vomiting is a problem
Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
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
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
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
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Sulindac	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where severe pain is a problem
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Temazepam	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where insomnia is a problem
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred

Adrenaline	—
Amoxycillin	—
Amoxycillin with Clavulanic Acid	Infections where resistance to moxicillin trihydrate is suspected
Infections where resistance to moxicillin trihydrate is proven
Amphotericin	—
Ampicillin	—
Aspirin	—
Atropine	—
Benzathine benzylpenicillin	—
Benzathine Penicillin	—
Benztropine	—
Benzydamine	Radiation induced mucositis
Benzylpenicillin	—
Betamethasone	For local intra‑articular or peri‑articular infiltration
Keloid
Lichen planus hypertrophic
Carbamazepine	—
Cefaclor	—
Cefotaxime	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Cefuroxime	—
Cephalexin	—
Cephalothin	—
Chloramphenicol	—
Clindamycin	Gram‑positive coccal infections where these cannot be safely and effectively treated with a penicillin
Codeine	—
Codeine with Paracetamol	—
Diazepam	—
Diclofenac	In respect of the tablet (enteric coated) containing diclofenac sodium 25 mg and tablet (enteric coated) containing diclofenac sodium 50 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository containing diclofenac sodium 100 mg: —
Dicloxacillin	In respect of the capsule 250 mg (as sodium) and capsule 500 mg (as sodium): Serious staphylococcal infections
In respect of the powder for injection 500 mg (as sodium) and powder for injection 1 g (as sodium): —
Doxycycline	—
Erythromycin	—
Flucloxacillin	In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL, powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL: Serious staphylococcal infections
In respect of the powder for injection 500 mg (as sodium) and powder for injection 1 g (as sodium): —
Glucagon	—
Glucose	—
Glyceryl Trinitrate	—
Hydrocortisone	In respect of the injection 100 mg (as sodium succinate) with 2 Ml solvent and injection 250 mg (as sodium succinate) with 2 Ml solvent: For use in a hospital
In respect of the cream containing hydrocortisone acetate 10 mg per g, 30 g, cream containing hydrocortisone acetate 10 mg per g, 50 g, ointment containing hydrocortisone acetate 10 mg per g, 30 g and ointment containing hydrocortisone acetate 10 mg per g, 50 g: Treatment of corticosteroid‑responsive dermatoses
Hydromorphone	In respect of the tablet containing hydromorphone hydrochloride 2 mg, tablet containing hydromorphone hydrochloride 4 mg, tablet containing hydromorphone hydrochloride 8 mg and oral liquid containing hydromorphone hydrochloride 1 mg per Ml, 473 Ml: Severe disabling pain not responding to non‑narcotic analgesics
In respect of the injection containing hydromorphone hydrochloride 2 mg in 1 Ml, injection containing hydromorphone hydrochloride 10 mg in 1 Ml and injection containing hydromorphone hydrochloride 50 mg in 5 Ml: —
Ibuprofen	In respect of the tablet 200 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the tablet 400 mg: —
Indomethacin	In respect of the capsule 25 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository 100 mg: —
Ketoprofen	In respect of the capsule 200 mg (sustained release): Chronic arthropathies (including osteoarthritis) with an inflammatory component
In respect of the suppository 100 mg: —
Lignocaine	—
Lincomycin	—
Methylprednisolone	For local intra‑articular or peri‑articular infiltration
Metoclopramide	—
Metronidazole	In respect of the tablet 200 mg, tablet 400 mg, oral suspension containing metronidazole benzoate 320 mg per 5 Ml, 100 Ml 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
Morphine	In respect of the tablet containing morphine sulfate 30 mg, oral solution containing morphine hydrochloride 2 mg per Ml, 200 Ml, oral solution containing morphine hydrochloride 5 mg per Ml, 200 Ml and oral solution containing morphine hydrochloride 10 mg per Ml, 200 Ml: Severe disabling pain not responding to non‑narcotic analgesics
In respect of the tablet containing morphine sulfate 5 mg (controlled release), tablet containing morphine sulfate 10 mg (controlled release), tablet containing morphine sulfate 15 mg (controlled release), tablet containing morphine sulfate 30 mg (controlled release), tablet containing morphine sulfate 60 mg (controlled release), tablet containing morphine sulfate 100 mg (controlled release), capsule containing morphine sulfate 10 mg (containing sustained release pellets), capsule containing morphine sulfate 20 mg (containing sustained release pellets), capsule containing morphine sulfate 30 mg (controlled release), capsule containing morphine sulfate 50 mg (containing sustained release pellets), capsule containing morphine sulfate 60 mg (controlled release), capsule containing morphine sulfate 90 mg (controlled release), capsule containing morphine sulfate 100 mg (containing sustained release pellets), capsule containing morphine sulfate 120 mg (controlled release), sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet, sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet, sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet and sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet: Chronic severe disabling pain not responding to non‑narcotic analgesics
In respect of the injection containing morphine sulfate 10 mg in 1 Ml, injection containing morphine sulfate 15 mg in 1 Ml and injection containing morphine sulfate 30 mg in 1 Ml: —
Naloxone	—
Naproxen	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Nitrazepam	—
Nystatin	—
Oxazepam	—
Oxycodone	In respect of the tablet containing oxycodone hydrochloride 5 mg, capsule containing oxycodone hydrochloride 5 mg, capsule containing oxycodone hydrochloride 10 mg, capsule containing oxycodone hydrochloride 20 mg, oral solution containing oxycodone hydrochloride 5 mg per 5 Ml, 250 Ml and suppository 30 mg (as pectinate): Severe disabling pain not responding to non‑narcotic analgesics
In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non‑narcotic analgesics
Paracetamol	—
Phenoxymethylpenicillin	—
Piroxicam	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Procaine Penicillin	—
Prochlorperazine	—
Promethazine	—
Sodium Chloride	—
Sodium Chloride with Glucose	—
Sulindac	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Temazepam	—
Ticarcillin with Clavulanic Acid	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Tramadol	In respect of the capsule containing tramadol hydrochloride 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 containing tramadol hydrochloride 50 mg (sustained release), tablet containing tramadol hydrochloride 100 mg (sustained release), tablet containing tramadol hydrochloride 150 mg (sustained release), tablet containing tramadol hydrochloride 200 mg (sustained release) and oral drops containing tramadol hydrochloride 100 mg per Ml, 10 Ml: For pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the injection containing tramadol hydrochloride 100 mg in 2 Ml: Short‑term treatment of acute pain
Triamcinolone	For local intra‑articular or peri‑articular infiltration
Keloid
Lichen planus hypertrophic
Trimethoprim with Sulfamethoxazole	—
Vancomycin	Prophylaxis of endocarditis in patients hypersensitive to penicillin

Aciclovir	Herpes simplex keratitis
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
Carmellose	In respect of the eye drops containing carmellose sodium 5 mg per Ml, 15 Ml and eye drops containing carmellose sodium 10 mg per Ml, 15 Ml: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye drops containing carmellose sodium 2.5 mg per Ml, single dose units 0.6 Ml, 24, eye drops containing carmellose sodium 5 mg per Ml, single dose units 0.4 Ml, 30, eye drops containing carmellose sodium 10 mg per Ml, single dose units 0.4 Ml, 30 and ocular lubricating gel containing carmellose sodium 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
Chloramphenicol	—
Cromoglycic Acid	Vernal kerato‑conjunctivitis
Fluorometholone	—
Flurbiprofen	—
Hydrocortisone	—
Hypromellose	Severe dry eye syndrome, including Sjogren’s syndrome
Hypromellose with Carbomer 980	Severe dry eye syndrome, including Sjogren’s syndrome
Hypromellose with Dextran	In respect of the eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per Ml, 15 Ml: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per Ml, single dose units 0.4 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
Paraffin	—
Polyethylene Glycol 400 with Propylene Glycol	Severe dry eye syndrome, including Sjogren’s syndrome
Polyvinyl Alcohol	Severe dry eye syndrome, including Sjogren’s syndrome
Sulfacetamide	—
Tamarindus indica seed polysaccharide	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

Abacavir	Abacavir with Lamivudine Abacavir with Lamivudine and Zidovudine
Alendronic Acid	Alendronic Acid with Colecalciferol
Alginic Acid	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Aluminium Hydroxide	Aluminium Hydroxide with Magnesium Hydroxide Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Amiloride	Hydrochlorothiazide with Amiloride
Amlodipine	Amlodipine with Atorvastatin
Amoxycillin	Amoxycillin with Clavulanic Acid Amoxycillin with Clavulanic Acid and Water – Purified BP Amoxycillin with Water – Purified BP
Aspirin	Dipyridamole with Aspirin
Atorvastatin	Amlodipine with Atorvastatin
Atropine	Diphenoxylate with Atropine
Azithromycin	Azithromycin with Water – Purified BP
Bacitracin	Neomycin with Bacitracin
Benserazide	Levodopa with Benserazide
Brimonidine	Brimonidine with Timolol
Budesonide	Budesonide with Eformoterol
Buprenorphine	Buprenorphine with Naloxone
Calcium	Calcium with colecalciferol
Calcium Carbonate	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Candesartan	Candesartan with Hydrochlorothiazide
Carbidopa	Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Carbomer 980	Hypromellose with Carbomer 980
Cefaclor	Cefaclor with Water – Purified BP
Cephalexin	Cephalexin with Water – Purified BP
Chlorhexidine	Silver Sulfadiazine with Chlorhexidine
Clavulanic Acid	Amoxycillin with Clavulanic Acid Amoxycillin with Clavulanic Acid and Water – Purified BP Ticarcillin with Clavulanic Acid
Codeine	Codeine with Paracetamol
Colecalciferol	Alendronic Acid with Colecalciferol Calcium with colecalcifero
Dexamethasone	Dexamethasone with Framycetin and Gramicidin
Dextran	Hypromellose with Dextran
Diphenoxylate	Diphenoxylate with Atropine
Dipyridamole	Dipyridamole with Aspirin
Dorzolamide	Dorzolamide with Timolol
Dydrogesterone	Oestradiol with Dydrogesterone
Eformoterol	Budesonide with Eformoterol
Emtricitabine	Tenofovir with Emtricitabine
Enalapril	Enalapril with Hydrochlorothiazide Lercanidipine with enalapril
Entacapone	Levodopa with Carbidopa and Entacapone
Eprosartan	Eprosartan with Hydrochlorothiazide
Erythromycin	Erythromycin with Water – Purified BP
Ethinyloestradiol	Levonorgestrel with Ethinyloestradiol Norethisterone with Ethinyloestradiol
Ezetimibe	Ezetimibe with Simvastatin
Felodipine	Ramipril with Felodipine
Ferrous Fumarate	Ferrous Fumarate with Folic Acid
Flucloxacillin	Flucloxacillin with Water – Purified BP
Fluticasone	Fluticasone with Salmeterol
Folic Acid	Ferrous Fumarate with Folic Acid
Fosinopril	Fosinopril with Hydrochlorothiazide
Framycetin	Dexamethasone with Framycetin and Gramicidin
Frangula Bark	Sterculia with Frangula Bark
Glibenclamide	Metformin with Glibenclamide
Glucose	Sodium Chloride with Glucose
Gramicidin	Dexamethasone with Framycetin and Gramicidin Triamcinolone with Neomycin, Gramicidin and Nystatin
Hydrochlorothiazide	Candesartan with Hydrochlorothiazide
Enalapril with Hydrochlorothiazide
Eprosartan with Hydrochlorothiazide
Fosinopril with Hydrochlorothiazide
Hydrochlorothiazide with Amiloride
Hydrochlorothiazide with Triamterene
Irbesartan with Hydrochlorothiazide
Olmesartan with Hydrochlorothiazide
Quinapril with Hydrochlorothiazide
Telmisartan with Hydrochlorothiazide
Hypromellose	Hypromellose with Carbomer 980 Hypromellose with Dextran
Indapamide	Perindopril with Indapamide
Insulin Aspart	Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Aspart Protamine Suspension	Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Isophane	Insulin Neutral with Insulin Isophane
Insulin Lispro	Insulin Lispro with Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension	Insulin Lispro with Insulin Lispro Protamine Suspension
Insulin Neutral	Insulin Neutral with Insulin Isophane
Irbesartan	Irbesartan with Hydrochlorothiazide
Lamivudine	Abacavir with Lamivudine Abacavir with Lamivudine and Zidovudine Lamivudine with Zidovudine
Latanoprost	Latanoprost with Timolol
Lercanidipine	Lercanidipine with enalapril
Levodopa	Levodopa with Benserazide Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Levonorgestrel	Levonorgestrel with Ethinyloestradiol
Lopinavir	Lopinavir with Ritonavir
Magnesium Hydroxide	Aluminium Hydroxide with Magnesium Hydroxide Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Magnesium Trisilicate	Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Medroxyprogesterone	Oestrogens—Conjugated with Medroxyprogesterone
Mestranol	Norethisterone with Mestranol
Metformin	Metformin with Glibenclamide Rosiglitazone with Metformin
Mycophenolic Acid	Mycophenolic Acid with Water – Purified BP
Naloxone	Buprenorphine with Naloxone
Neomycin	Neomycin with Bacitracin Triamcinolone with Neomycin, Gramicidin and Nystatin
Norethisterone	Norethisterone with Ethinyloestradiol Norethisterone with Mestranol Oestradiol with Norethisterone
Nystatin	Triamcinolone with Neomycin, Gramicidin and Nystatin
Oestradiol	Oestradiol with Dydrogesterone Oestradiol with Norethisterone
Oestrogens—Conjugated	Oestrogens—Conjugated with Medroxyprogesterone
Olmesartan	Olmesartan with Hydrochlorothiazide
Paracetamol	Codeine with Paracetamol
Perindopril	Perindopril with Indapamide
Phenylephrine	Prednisolone with Phenylephrine
Polyethylene Glycol 400	Polyethylene Glycol 400 with Propylene Glycol
Potassium Bicarbonate	Potassium Chloride with Potassium Bicarbonate
Potassium Chloride	Potassium Chloride with Potassium Bicarbonate
Prednisolone	Prednisolone with Phenylephrine
Propylene Glycol	Polyethylene Glycol 400 with Propylene Glycol
Quinapril	Quinapril with Hydrochlorothiazide
Ramipril	Ramipril with Felodipine
Ritonavir	Lopinavir with Ritonavir
Rosiglitazone	Rosiglitazone with Metformin
Salmeterol	Fluticasone with Salmeterol
Silver Sulfadiazine	Silver Sulfadiazine with Chlorhexidine
Simvastatin	Ezetimibe with Simvastatin
Sodium Bicarbonate	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Sodium Chloride	Sodium Chloride with Glucose
Sodium Citrate	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
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
Tenofovir	Tenofovir with Emtricitabine
Ticarcillin	Ticarcillin with Clavulanic Acid
Timolol	Brimonidine with Timolol
Dorzolamide with Timolol
Latanoprost with Timolol
Travoprost with Timolol
Trandolapril	Trandolapril with Verapamil
Travoprost	Travoprost with Timolol
Triamcinolone	Triamcinolone with Neomycin, Gramicidin and Nystatin
Triamterene	Hydrochlorothiazide with Triamterene
Trimethoprim	Trimethoprim with Sulfamethoxazole
Verapamil	Trandolapril with Verapamil
Water – Purified BP	Amoxycillin with Clavulanic Acid and Water – Purified BP
Amoxycillin with Water – Purified BP
Azithromycin with Water – Purified BP
Cefaclor with Water – Purified BP
Cephalexin with Water – Purified BP
Erythromycin with Water – Purified BP
Flucloxacillin with Water – Purified BP
Mycophenolic Acid with Water – Purified BP
Stavudine with Water – Purified BP
Zidovudine	Abacavir with Lamivudine and Zidovudine Lamivudine with Zidovudine

Acacia BP, powdered	—
Acetic Acid (33 per cent) BP	—
Alum BP	—
Aluminium Acetate Solution BP	—
Aqueous Cream APF	For use only as a base combined with active ingredients
Ascorbic Acid BP	For use only as an ingredient of ferrous sulfate mixtures
Aspirin BP	—
Belladonna Tincture BP	—
Benzocaine BP	—
Benzoic Acid BP	—
Benzoin Tincture Compound BP	—
Boric Acid, Olive Oil and Zinc Oxide Ointment QHF	—
Calcium Hydroxide BP	—
Cetomacrogol Cream, Aqueous APF	For use only as a base combined with active ingredients
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
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 Alkaline Mixture APF	—
Glycerol BP	—
Iodine BP	—
Kaolin Mixture BPC 1968	—
Kaolin and Opium Mixture APF 14	—
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	—
Paraffin, Hard BP	—
Paraffin, Light Liquid BP	—
Paraffin, Liquid BP	May only be prescribed for other than oral use
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	—
Propyl Hydroxybenzoate BP	—
Propylene Glycol 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	—

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

Sodium Thiosulfate BP

Abacavir

Abacavir with Lamivudine

Abacavir with Lamivudine and Zidovudine

Abatacept

Adefovir

Apomorphine

Atazanavir

Bosentan

Botulinum Toxin Type A Purified Neurotoxin Complex

Buprenorphine

Buprenorphine with Naloxone

Choriogonadotropin Alfa

Cidofovir

Clostridium Botulinum Type A Toxin—Haemagglutinin Complex

Clozapine

Darbepoetin Alfa

Darunavir

Deferasirox

Deferiprone

Delavirdine

Desferrioxamine

Didanosine

Dornase Alfa

Efavirenz

Emtricitabine

Enfuvirtide

Entecavir

Epoetin Alfa

Epoetin Beta

Epoprostenol

Filgrastim

Fosamprenavir

Foscarnet

Ganciclovir

Ibandronic acid

Iloprost

Indinavir

Infliximab

Interferon Gamma‑1b

Lamivudine

Lamivudine with Zidovudine

Lanreotide

Lenograstim

Lopinavir with Ritonavir

Natalizumab

Nelfinavir

Nevirapine

Octreotide

Pegfilgrastim

Peginterferon Alfa‑2a

Peginterferon Alfa‑2b

Progesterone

Raltegravir

Ribavirin and Peginterferon Alfa‑2a

Ribavirin and Peginterferon Alfa‑2b

Rifabutin

Ritonavir

Saquinavir

Sildenafil

Sitaxentan

Somatropin

Stavudine

Tenofovir

Tenofovir with Emtricitabine

Thalidomide

Tipranavir

Trastuzumab

Valganciclovir

Zidovudine

Zoledronic Acid

Notes to the Declaration and Determination — drugs and medicinal preparations (PB 88 of 2007)

Note 1

The Declaration and Determination — drugs and medicinal preparations (PB 88 of 2007) (in force under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of FRLI Registration	Date of commencement	Application, saving or transitional provisions
PB 88 of 2007	16 Nov 2007 (see F2007L04360)	1 Dec 2007
PB 1 of 2008	23 Nov 2007 (see F2007L04463)	1 Jan 2008	—
PB 6 of 2008	19 Dec 2007 (see F2007L04902)	1 Jan 2008	—
PB 14 of 2008	9 Jan 2008 (see F2008L00033)	1 Feb 2008	—
PB 23 of 2008	7 Feb 2008 (see F2008L00281)	1 Mar 2008	—
PB 30 of 2008	11 Mar 2008 (see F2008L00691)	1 Apr 2008	—
PB 41 of 2008	10 Apr 2008 (see F2008L01027)	1 May 2008	—
PB 50 of 2008	12 May 2008 (see F2008L01382)	1 June 2008	—
PB 59 of 2008	10 June 2008 (see F2008L02048)	1 July 2008	—

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
S. 4B................................................	ad. PB 6 of 2008
S. 12.................................................	am. PB 6 of 2008
S. 14.................................................	am. PB 6 of 2008
S. 15.................................................	am. PB 6 of 2008
S. 15A..............................................	am. PB 6 of 2008
S. 15B..............................................	am. PB 6 of 2008
Schedule 1
Schedule 1.....................................	am. PB 1, 6, 14, 23, 30, 41, 50 and 59 of 2008
Schedule 1A
Schedule 1A...................................	am. PB 6 and 30 of 2008
Schedule 2
Schedule 2.....................................	am. PB 6, 30, 41 and 50 of 2008
Schedule 2A
Schedule 2A...................................	ad. PB 6 of 2008
am. PB 14 of 2008
Schedule 3
Schedule 3.....................................	am. PB 41 of 2008
Schedule 4
Schedule 4.....................................	am. PB 6 of 2008
Schedule 6
Schedule 6.....................................	am. PB 23, 30 and 59 of 2008