National Health Act 1953 Declaration under subsection 85(2) (No. PB 21 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DECLARATION UNDER SUBSECTION 85(2)

No. PB 21 of 2007

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subsection 85(2) of the National Health Act 1953, hereby make the following Declaration:

1. This declaration commences on 1 April 2007.

2. Declaration No. PB 13 of 2007 under subsection 85(2) of the National Health Act 1953 made on 14 February 2007 with effect from 1 March 2007 is repealed.

3. In this Declaration:

“Act” means the National Health Act 1953;

“base-priced drug” means —

(a) in relation to ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or

(b) in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release));

“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 drug or medicinal preparation in respect of which there is in force a determination under subsection 85(6) of the Act;

“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.

4. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances (if any) specified in column 2 of Schedule 1 or 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner.

4A. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 2 and the circumstances (if any) specified in column 2 of Schedule 2 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a participating dental practitioner.

5. A medicinal preparation composed of a compound that includes a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3, other than a compound the name of which is specified in column 2 of that Schedule opposite the name of that pharmaceutical benefit, is not a medicinal preparation to which Part VII of the Act applies, unless the name of that pharmaceutical benefit is also specified in Schedule 4, in which case the provisions of paragraphs 7 and 8 apply.

6. Part VII of the Act does not apply in relation to a medicinal preparation composed of a compound that includes a ready-prepared pharmaceutical benefit, other than a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3.

7. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4.

8. Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4 with the addition of one or more of the substances the names of which are specified in Schedule 5.

9. The substances the names of which are specified in Schedule 5 are additives for the purposes of paragraph 85(2)(b) of the Act.

10. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in Schedule 6.

11. The drugs and medicinal preparations the names of which are specified in Schedule 6 are additional pharmaceutical benefits made available under arrangements provided for by section 100 of the Act.

12. Where circumstances are specified in column 2 of Schedule 1, 1A, 2 or 4 opposite the name of a pharmaceutical benefit specified in column 1 of any of those Schedules, that pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

13. Where circumstances are specified in column 2 of Schedule 4 opposite the name of a pharmaceutical benefit specified in column 1 of that Schedule, those circumstances are also specified in relation to any medicinal preparation containing that pharmaceutical benefit.

14. Subject to paragraph 16, the following circumstances are specified in relation to each relevant pharmaceutical benefit for the purposes of section 88A of the Act:

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

(b) where a disease or condition is specified in column 2 of Schedule 1, 1A, 2 or 4 —

(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or

(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;

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

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

(i) by preparing and signing the prescription:

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

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

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

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

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

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

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

14A. For the purposes of subsubparagraph 14(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.

15. Subject to paragraph 15B, the authorisation of a prescription submitted under subparagraph 14(d) may be made:

(a) if the prescription was submitted in accordance with subsubparagraph 14(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or

(ii) in any other case:

(A) by returning it to the medical practitioner; or

(B) by sending it to the person in respect of whom it was prepared; or

(b) if the prescription was submitted in accordance with subsubparagraph 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; and

(b) the medical practitioner must:

(i) mark that number on the prescription; and

(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

15B. Notwithstanding paragraph 15, if the prescription was submitted in accordance with subsubparagraph 14(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.

16. Where the circumstances “For use in accordance with paragraph 16” are specified in column 2 of Schedule 1, the circumstances specified for the purpose of subparagraph 14(c) are:

(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

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): Patients undergoing percutaneous coronary balloon angioplasty
Patients undergoing percutaneous coronary atherectomy
Patients undergoing percutaneous coronary stent placement
Acamprosate Calcium	In compliance with authority procedures set out in subparagraph 14 (d): For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence
Acarbose	—
Acetazolamide	—
Acetylcysteine Sodium	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): Severe intractable psoriasis Severe forms of disorders of keratinisation
Adalimumab	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or
(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, 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 within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
patients are eligible to commence therapy with adalimumab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of adalimumab therapy specified below, if applicable;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of adalimumab therapy;
a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, 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 adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with adalimumab; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
- shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
a course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, 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 with a record of rheumatoid factor negative status within the last 12 months; 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 sulfasalazine at a dose of at least 2 g per day 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 either methotrexate or sulfasalazine, 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 with a record of rheumatoid factor negative status within the last 12 months, 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 with a record of rheumatoid factor negative status within the last 12 months; 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 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 with a record of rheumatoid factor negative status within the last 12 months, 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 with a record of rheumatoid factor negative status within the last 12 months; 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 with a record of rheumatoid factor negative status within the last 12 months, 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 with a record of rheumatoid factor negative status; 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 with a record of rheumatoid factor negative status, 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 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
Adrenaline Acid Tartrate	—
Albendazole	In respect of the tablet 200 mg:
In compliance with authority procedures set out in subparagraph 14 (d): Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person
Treatment of tapeworm infestation
In respect of the tablet 400 mg:
In compliance with authority procedures set out in subparagraph 14 (d): For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used
Alendronate Sodium	In respect of the tablet equivalent to 70 mg alendronic acid:
In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are stated in the authority application
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, where the patient has previously been issued with an authority prescription for this drug
Initial 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 included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
In respect of the tablet equivalent to 40 mg alendronic acid:
In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone
Alendronate Sodium with Colecalciferol	In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are stated in the authority application
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older with a bone mineral density T-score of negative 3.0 or less, where the patient has previously been issued with an authority prescription for this drug
Initial 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 included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
"Alfaré"	In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 3 months, for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged less than 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to cows' milk protein in a child aged 2 years or over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Biliary atresia
Chronic liver failure with fat malabsorption
Chylous ascites
Chylothorax
Cystic fibrosis
Enterokinase deficiency
Proven fat malabsorption
Severe diarrhoea of greater than 2 weeks' duration in an infant aged less than 4 months, where the date of birth of the patient is included in the authority application
Severe intestinal malabsorption including short bowel syndrome
Allopurinol	—
Alprazolam	In compliance with authority procedures set out in subparagraph 14 (d): Panic disorder where other treatments have failed or are inappropriate
Aluminium Hydroxide - Dried with Magnesium Hydroxide	—
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide	—
Amantadine Hydrochloride	Parkinson's disease which is not drug induced
Amiloride Hydrochloride	—
Aminoglutethimide	—
Amiodarone Hydrochloride	Severe cardiac arrhythmias
Amisulpride	In compliance with authority procedures set out in subparagraph 14 (d): Schizophrenia
Amitriptyline Hydrochloride	—
Amlodipine Besylate	—
Amlodipine Besylate with Atorvastatin Calcium	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 Trihydrate	In respect of the tablet, chewable, equivalent to 250 mg amoxycillin, capsule equivalent to 250 mg amoxycillin, capsule equivalent to 500 mg amoxycillin and sachet containing oral powder equivalent to 3 g amoxycillin:
—
In respect of the tablet equivalent to 1 g amoxycillin:
Acute exacerbations of chronic bronchitis
Amoxycillin Trihydrate with Potassium Clavulanate	Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP	Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Water - Purified BP	—
Amphotericin	—
Ampicillin Sodium	—
Ampicillin Trihydrate	—
Anakinra	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
(ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
(b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless:
(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or
(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
(c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, 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 within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
patients are eligible to commence therapy with anakinra within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of anakinra therapy specified below, if applicable; unless this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, in which case the patient is eligible to commence therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised anakinra treatment; and
(ii) the response was assessed, and the assessment was provided to the 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of anakinra therapy;
a course of treatment is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, 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): Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
the course of treatment is limited to a maximum of 24 weeks of treatment
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:
(a) who have demonstrated an adequate response to treatment with anakinra; and
(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and
where bDMARD means a drug included in the following list of drugs:
adalimumab, anakinra, etanercept or infliximab; and
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
a course of treatment is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, 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 Acetate	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 (AMD), 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 (AMD), 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 Hydrochloride	Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy
Aprepitant	In compliance with authority procedures set out in subparagraph 14 (d): Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:
altretamine;
carmustine;
cisplatin, when a single dose constitutes a cycle of chemotherapy;
cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
dacarbazine;
procarbazine, when a single dose constitutes a cycle of chemotherapy;
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): Schizophrenia
Aspirin	—
Atenolol	—
Atorvastatin Calcium	For use in accordance with paragraph 16
Atovaquone	In compliance with authority procedures set out in subparagraph 14 (d): Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy
Atropine Sulfate	—
Auranofin	—
Azathioprine	—
Azithromycin Dihydrate	Uncomplicated urethritis due to Chlamydia trachomatis Uncomplicated cervicitis due to Chlamydia trachomatis Trachoma
Azithromycin Dihydrate with Water - Purified BP	Trachoma
Baclofen	—
Balsalazide Sodium	In compliance with authority procedures set out in subparagraph 14 (d): Ulcerative colitis where hypersensitivity to sulfonamides exists Ulcerative colitis where intolerance to sulfasalazine exists
"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)	Treatment of carcinoma in situ of the urinary bladder
"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)	Primary and relapsing superficial urothelial carcinoma of the bladder
Beclomethasone Dipropionate	In respect of the pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation):
—
In respect of the pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation):
Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug
Benzathine Penicillin	—
Benzhexol Hydrochloride	—
Benztropine Mesylate	—
Benzydamine Hydrochloride	Radiation induced mucositis
Benzylpenicillin Sodium	—
Betamethasone Acetate with Betamethasone Sodium Phosphate	Alopecia areata
For local intra-articular or peri-articular infiltration
Granulomata, dermal
Keloid
Lichen planus hypertrophic
Lichen simplex chronicus
Lupus erythematosus, chronic discoid
Necrobiosis lipoidica
Uveitis
Betamethasone Dipropionate	Treatment of corticosteroid-responsive dermatoses
Betamethasone Valerate	Treatment of corticosteroid-responsive dermatoses
Betaxolol Hydrochloride	—
Bethanechol Chloride	—
Bicalutamide	In compliance with authority procedures set out in subparagraph 14 (d): Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy
Bifonazole	In compliance with authority procedures set out in subparagraph 14 (d): Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person
Bimatoprost	—
Biperiden Hydrochloride	—
Bisacodyl	Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
Patients receiving palliative care
Terminal malignant neoplasia
Anorectal congenital abnormalities
Megacolon
Bisoprolol Fumarate	In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated
Bivalirudin Trifluoroacetate	In compliance with authority procedures set out in subparagraph 14 (d): Patients undergoing non-emergency percutaneous coronary intervention
Bleomycin Sulfate	Germ cell neoplasms Lymphoma
Brimonidine Tartrate	—
Brimonidine Tartrate with Timolol Maleate	Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Brinzolamide	—
Bromocriptine Mesylate	In respect of the tablet equivalent to 2.5 mg bromocriptine:
Prevention of the onset of lactation in the puerperium for medical reasons
Acromegaly
Parkinson's disease
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
In respect of the capsule equivalent to 5 mg bromocriptine and capsule equivalent to 10 mg bromocriptine:
Acromegaly
Parkinson's disease
Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Budesonide	In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30:
In compliance with authority procedures set out in subparagraph 14 (d): Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy
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 Fumarate Dihydrate	Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide
Buprenorphine	Chronic severe disabling pain not responding to non-narcotic analgesics
Bupropion Hydrochloride	In compliance with authority procedures set out in subparagraph 14 (d): Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where details of the program are specified in the authority application
Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who are entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application
Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug
Busulfan	—
Cabergoline	In respect of the tablet 500 micrograms:
Prevention of the onset of lactation in the puerperium for medical reasons
In compliance with authority procedures set out in subparagraph 14 (d): Pathological hyperprolactinaemia where surgery is not indicated
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
Pathological hyperprolactinaemia where radiotherapy is not indicated
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg:
Parkinson's disease
Calcipotriol	Chronic stable plaque type psoriasis vulgaris
Calcitriol	In compliance with authority procedures set out in subparagraph 14 (d): Hypocalcaemia due to renal disease
Hypoparathyroidism
Hypophosphataemic rickets
Vitamin D-resistant rickets
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Calcium Carbonate	In compliance with authority procedures set out in subparagraph 14 (d): Hyperphosphataemia associated with chronic renal failure
Calcium Citrate	In compliance with authority procedures set out in subparagraph 14 (d): Hyperphosphataemia associated with chronic renal failure
Calcium Folinate	In respect of the tablet equivalent to 15 mg folinic acid:
Antidote to folic acid antagonists
In respect of the injection equivalent to 50 mg folinic acid in 5 mL, injection equivalent to 100 mg folinic acid in 10 mL and injection equivalent to 300 mg folinic acid in 30 mL:
—
Candesartan Cilexetil	—
Candesartan Cilexetil with Hydrochlorothiazide	Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil
Capecitabine	In compliance with authority procedures set out in subparagraph 14 (d): Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline
Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated
Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy
Treatment of advanced or metastatic colorectal cancer
Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour
"Caprilon"	Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders
Captopril	In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg:
—
In respect of the oral solution 5 mg per mL, 95 mL:
For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor
Carbamazepine	—
Carbimazole	—
"Carbohydrate Free Mixture"	Patients with intractable seizures requiring treatment with a ketogenic diet
Glucose transport protein defects
Pyruvate dehydrogenase deficiency
Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance
Carbomer 974	In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carbomer 980	In respect of the ocular lubricating gel 2 mg per g, 10 g:
Severe dry eye syndrome, including Sjogren's syndrome
In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30:
In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carboplatin	—
Carmellose Sodium	In respect of the eye drops 5 mg per mL, 15 mL and eye drops 10 mg per mL, 15 mL:
Severe dry eye syndrome, including Sjogren's syndrome
In respect of the eye drops 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops 5 mg per mL, single dose units 0.4 mL, 30, eye drops 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28:
In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carmustine	Glioblastoma multiforme, suspected or confirmed, at the time of initial surgery
Carvedilol	In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002
Cefaclor Monohydrate	—
Cefaclor Monohydrate with Water - Purified BP	—
Cefepime Hydrochloride	In compliance with authority procedures set out in subparagraph 14 (d): Treatment of febrile neutropenia
Cefotaxime Sodium	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven
Ceftriaxone Sodium	In respect of the powder for injection equivalent to 500 mg ceftriaxone:
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 equivalent to 1 g ceftriaxone and powder for injection equivalent to 2 g ceftriaxone:
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Cefuroxime Axetil	—
Celecoxib	Symptomatic treatment of osteoarthritis Symptomatic treatment of rheumatoid arthritis
Cephalexin	—
Cephalexin with Water - Purified BP	—
Cephalothin Sodium	—
Cephazolin Sodium	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven
Chlorambucil	—
Chloramphenicol	—
Chlorpromazine Hydrochloride	—
Chlorthalidone	—
Cholestyramine	—
Chorionic Gonadotrophin	In respect of the injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL:
Anovulatory infertility
For the treatment of infertility in males due to hypogonadotrophic hypogonadism
For the treatment of infertility in males associated with isolated luteinising hormone deficiency
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty
Cryptorchism not due to organic obstruction in boys over 12 months of age
In respect of the injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL:
Anovulatory infertility
For the treatment of infertility in males due to hypogonadotrophic hypogonadism
For the treatment of infertility in males associated with isolated luteinising hormone deficiency
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty
Ciclesonide	—
Cimetidine	—
Ciprofloxacin Hydrochloride	In respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin:
In compliance with authority procedures set out in subparagraph 14 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
In respect of the tablet equivalent to 250 mg ciprofloxacin:
Gonorrhoea
In compliance with authority procedures set out in subparagraph 14 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
In respect of the ear drops equivalent to 3 mg ciprofloxacin 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 year and older
In respect of the eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL:
In compliance with authority procedures set out in subparagraph 14 (d): Bacterial keratitis
Cisplatin	—
Citalopram Hydrobromide	Major depressive disorders
Cladribine	In compliance with authority procedures set out in subparagraph 14 (d): Hairy cell leukaemia
Clarithromycin	—
Clindamycin Hydrochloride	Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin
Clomiphene Citrate	Anovulatory infertility Patients undergoing in-vitro fertilisation
Clomipramine Hydrochloride	Cataplexy associated with narcolepsy
Obsessive-compulsive disorder
Phobic disorders in adults
Clonazepam	In respect of the 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 Hydrochloride	—
Clopidogrel Hydrogen Sulfate	In compliance with authority procedures set out in subparagraph 14 (d): Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:
in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Prevention of recurrence of myocardial infarction or unstable angina:
in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Clotrimazole	In compliance with authority procedures set out in subparagraph 14 (d):

Coal Tar - Prepared	—
Codeine Phosphate	—
Codeine Phosphate with Paracetamol	—
Colchicine	—
Colestipol Hydrochloride	—
Copper Sulfate	—
Cortisone Acetate	—
Cyclophosphamide	—
Cyclosporin	In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
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 Hydrochloride	Prevention of migraine
Cyproterone Acetate	In respect of the tablet 50 mg:
In compliance with authority procedures set out in subparagraph 14 (d): Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women
Advanced carcinoma of the prostate
To reduce drive in sexual deviations in males
In respect of the tablet 100 mg:
In compliance with authority procedures set out in subparagraph 14 (d): Advanced carcinoma of the prostate
To reduce drive in sexual deviations in males
Cytarabine	—
Dalteparin Sodium	—
Danazol	In compliance with authority procedures set out in subparagraph 14 (d): Endometriosis, visually proven
Hereditary angio-oedema
Treatment, for up to 6 months, of intractable primary menorrhagia
Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments
Dantrolene Sodium	Treatment of chronic spasticity
Dapsone	—
Desmopressin Acetate	In respect of the intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle:
In compliance with authority procedures set out in subparagraph 14 (d): Cranial diabetes insipidus
In respect of the tablet 200 micrograms and nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL:
In compliance with authority procedures set out in subparagraph 14 (d): Primary nocturnal enuresis:
in patients aged 6 years or older who are refractory to an enuresis alarm, where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose
in patients aged 6 years or older for whom an enuresis alarm is contraindicated, where the reason for the contraindication is included in the authority application, and where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose
Cranial diabetes insipidus
Dexamethasone	—
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin	—
Dexamethasone Sodium Phosphate	—
Dexamphetamine Sulfate	In compliance with authority procedures set out in subparagraph 14 (d): Use in attention deficit hyperactivity disorder, in accordance with State/Territory law Narcolepsy
"Dialamine"	Gyrate atrophy of the choroid and retina Urea cycle disorders
Diazepam	—
Diclofenac Sodium	In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository 100 mg:
—
Dicloxacillin Sodium	In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin:
Serious staphylococcal infections
In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin:
—
"Digestelact"	In compliance with authority procedures set out in subparagraph 14 (d): Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Digoxin	—
Dihydroergotamine Mesylate	—
Diltiazem Hydrochloride	—
Diphenoxylate Hydrochloride with Atropine Sulfate	—
Diphtheria and Tetanus Vaccine - Adsorbed	—
Diphtheria and Tetanus Vaccine - Adsorbed (Diluted)	—
Dipivefrine Hydrochloride	—
Dipyridamole	Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events:
in patients receiving therapy with low-dose aspirin
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
Dipyridamole with Aspirin	Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events
Disodium Etidronate	In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects
Heterotopic ossification
Disodium Etidronate and Calcium Carbonate	In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment 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 included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body Continuing treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug
Disodium Pamidronate	In compliance with authority procedures set out in subparagraph 14 (d): Symptomatic Paget's disease of bone
Disopyramide	—
Docetaxel	In compliance with authority procedures set out in subparagraph 14 (d): Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound
Locally advanced or metastatic non-small cell lung cancer
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Dolasetron Mesylate	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy
Domperidone	—
Donepezil Hydrochloride	In compliance with authority procedures set out in subparagraph 14 (d): Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total
Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more who demonstrate improvement in cognitive function following initial PBS-subsidised therapy, and where:
(1) improvement in cognitive function is demonstrated by:
(a) in the case of patients with a baseline MMSE or SMMSE score of 10 or more and less than 25 — an increase of at least 2 points from baseline on the MMSE or SMMSE; or
(b) in the case of patients with a baseline MMSE or SMMSE score of at least 25 points — an increase of at least 2 points from baseline on the MMSE or SMMSE, or, if a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) was submitted with the application for initial treatment, a decrease of at least 4 points from baseline on the ADAS-Cog; and
(2) the relevant result from the MMSE, SMMSE or ADAS-Cog is included in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d):
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more and with demonstrated improvement in cognitive function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total
Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial PBS-subsidised therapy, based on a rating of "very much improved" or "much improved" on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment
In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less and with demonstrated improvement in function following initial PBS-subsidised therapy, where the patient has previously been issued with an authority prescription for continuing treatment
Dorzolamide Hydrochloride	—
Dorzolamide Hydrochloride with Timolol Maleate	Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Dothiepin Hydrochloride	—
Doxepin Hydrochloride	—
Doxorubicin Hydrochloride	—
Doxorubicin Hydrochloride - Pegylated Liposomal	In compliance with authority procedures set out in subparagraph 14 (d): Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated
Doxycycline Hydrochloride	In respect of the tablet equivalent to 50 mg doxycycline and capsule equivalent to 50 mg doxycycline (containing enteric coated pellets):
Bronchiectasis in patients aged 8 years or older
Chronic bronchitis in patients aged 8 years or older
Severe acne
In respect of the tablet equivalent to 100 mg doxycycline and capsule equivalent to 100 mg doxycycline (containing enteric coated pellets):
—
Doxycycline Monohydrate	In respect of the tablet equivalent to 50 mg doxycycline:
Bronchiectasis in patients aged 8 years or older
Chronic bronchitis in patients aged 8 years or older
Severe acne
In respect of the tablet equivalent to 100 mg doxycycline:
—
Drotrecogin Alfa (activated)	In compliance with authority procedures set out in subparagraph 14 (d): Adult patients with severe sepsis who have a high risk of death as determined by acute dysfunction in at least 2 organs or modified Acute Physiology and Chronic Health Evaluation II score of at least 25, where acute organ dysfunction is defined as follows:
For cardiovascular-system dysfunction, an arterial systolic blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;
For kidney dysfunction, urine output of less than 0.5 mL per kg of body weight per hour for 1 hour despite adequate fluid resuscitation;
For respiratory-system dysfunction, a ratio of partial pressure of oxygen in arterial blood (in mmHg) to the percentage of oxygen in the inspired air (expressed as a decimal) of less than or equal to 250;
For haematologic dysfunction, a platelet count of less than 80,000 per cubic millimetre or which has decreased by 50 percent in the previous 3 days;
In the case of unexplained metabolic acidosis, a pH of less than or equal to 7.30 or a base deficit of greater than or equal to 5.0 mmol per L in association with a plasma lactate level of greater than 1.5 times the upper limit of the normal value for the reporting laboratory
"Duocal"	Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae
Dydrogesterone	—
"Easiphen"	Phenylketonuria
Efalizumab	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrable in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) a copy of the signed patient acknowledgement form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment as systemic monotherapy, in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with 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 efalizumab as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with efalizumab for the treatment of this condition more than once in the current Treatment Cycle; and
where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with efalizumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised efalizumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and wish to transfer to treatment with efalizumab are not eligible to commence treatment with efalizumab until they have completed a period free from biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and whole body area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within 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, or of a course which recommences treatment, with efalizumab as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
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 efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with efalizumab prior to 10 November 2005; and
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with efalizumab; and
(c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and
(d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and
where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) a copy of the signed patient acknowledgement form;
the most recent PASI assessment is no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and
where biological agent means efalizumab or etanercept; and
where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of efalizumab treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment;
the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and
(ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition;
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 as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with 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
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and

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 Hydrochloride	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 Sodium	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 Sodium	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
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 Butylbromide	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 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride	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 Hydrochloride	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 Sulfate	In respect of the tablet 10 mg and tablet 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 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 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
Naproxen Sodium	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
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 Hydrochloride	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 Acid Tartrate	—
Amoxycillin Trihydrate	—
Amoxycillin Trihydrate with Potassium Clavulanate	Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP	Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven
Amoxycillin Trihydrate with Water - Purified BP	—
Amphotericin	—
Ampicillin Sodium	—
Ampicillin Trihydrate	—
Aspirin	—
Atropine Sulfate	—
Benzathine Penicillin	—
Benztropine Mesylate	—
Benzydamine Hydrochloride	Radiation induced mucositis
Benzylpenicillin Sodium	—
Betamethasone Acetate with Betamethasone Sodium Phosphate	For local intra-articular or peri-articular infiltration Keloid Lichen planus hypertrophic
Carbamazepine	—
Cefaclor Monohydrate	—
Cefaclor Monohydrate with Water - Purified BP	—
Cefotaxime Sodium	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Cefuroxime Axetil	—
Cephalexin	—
Cephalexin with Water - Purified BP	—
Cephalothin Sodium	—
Chloramphenicol	—
Clindamycin Hydrochloride	Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin
Codeine Phosphate	—
Codeine Phosphate with Paracetamol	—
Diazepam	—
Diclofenac Sodium	In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated):
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository 100 mg:
—
Dicloxacillin Sodium	In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin:
Serious staphylococcal infections
In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin:
—
Doxycycline Hydrochloride	—
Doxycycline Monohydrate	—
Erythromycin	—
Erythromycin Ethyl Succinate	—
Erythromycin Ethyl Succinate with Water - Purified BP	—
Erythromycin Lactobionate	—
Flucloxacillin Magnesium with Water - Purified BP	Serious staphylococcal infections
Flucloxacillin Sodium	In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin:
Serious staphylococcal infections
In respect of the powder for injection equivalent to 500 mg flucloxacillin and powder for injection equivalent to 1 g flucloxacillin:
—
Glucagon Hydrochloride	—
Glucose	—
Glyceryl Trinitrate	—
Hydrocortisone Acetate	Treatment of corticosteroid-responsive dermatoses
Hydrocortisone Sodium Succinate	For use in a hospital
Hydromorphone Hydrochloride	In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule and injection 50 mg in 5 mL ampoule:
—
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 Hydrochloride	—
Lincomycin Hydrochloride	—
Methylprednisolone Acetate	For local intra-articular or peri-articular infiltration
Metoclopramide Hydrochloride	—
Metronidazole	In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10:
—
In respect of the I.V. infusion 500 mg in 100 mL:
Treatment, in a hospital, of acute anaerobic sepsis
Metronidazole Benzoate	—
Morphine Hydrochloride	Severe disabling pain not responding to non-narcotic analgesics
Morphine Sulfate	In respect of the tablet 30 mg:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet:
Chronic severe disabling pain not responding to non-narcotic analgesics
In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule:
—
Naloxone Hydrochloride	—
Naproxen	Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease
Naproxen Sodium	Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease
Nitrazepam	—
Nystatin	—
Oxazepam	—
Oxycodone Hydrochloride	In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL:
Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release):
Chronic severe disabling pain not responding to non-narcotic analgesics
Oxycodone Pectinate	Severe disabling pain not responding to non-narcotic analgesics
Paracetamol	—
Phenoxymethylpenicillin Benzathine	—
Phenoxymethylpenicillin Potassium	—
Piroxicam	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Procaine Penicillin	—
Prochlorperazine	—
Prochlorperazine Maleate	—
Prochlorperazine Mesylate	—
Promethazine Hydrochloride	—
Sodium Chloride	—
Sodium Chloride with Glucose	—
Sulindac	Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease
Temazepam	—
Ticarcillin Sodium with Potassium Clavulanate	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Tramadol Hydrochloride	In respect of the capsule 50 mg:
For acute pain where aspirin or paracetamol alone is inappropriate or has failed
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the tablet 50 mg (sustained release), tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL:
For pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the injection 100 mg in 2 mL ampoule:
Short-term treatment of acute pain
Triamcinolone Acetonide	For local intra-articular or peri-articular infiltration Keloid Lichen planus hypertrophic
Trimethoprim with Sulfamethoxazole	—
Vancomycin Hydrochloride	Prophylaxis of endocarditis in patients hypersensitive to penicillin

Abacavir Sulfate	Abacavir Sulfate with Lamivudine Abacavir Sulfate with Lamivudine and Zidovudine
Alendronate Sodium	Alendronate Sodium with Colecalciferol
Aluminium Hydroxide - Dried	Aluminium Hydroxide - Dried with Magnesium Hydroxide Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Amiloride Hydrochloride	Hydrochlorothiazide with Amiloride Hydrochloride
Amlodipine Besylate	Amlodipine Besylate with Atorvastatin Calcium
Amoxycillin Trihydrate	Amoxycillin Trihydrate with Potassium Clavulanate Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Amoxycillin Trihydrate with Water - Purified BP
Aspirin	Dipyridamole with Aspirin
Atorvastatin Calcium	Amlodipine Besylate with Atorvastatin Calcium
Atropine Sulfate	Diphenoxylate Hydrochloride with Atropine Sulfate
Azithromycin Dihydrate	Azithromycin Dihydrate with Water - Purified BP
Bacitracin Zinc	Neomycin Undecenoate with Bacitracin Zinc
Benserazide Hydrochloride	Levodopa with Benserazide Hydrochloride
Betamethasone Acetate	Betamethasone Acetate with Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate	Betamethasone Acetate with Betamethasone Sodium Phosphate
Brimonidine Tartrate	Brimonidine Tartrate with Timolol Maleate
Budesonide	Budesonide with Eformoterol Fumarate Dihydrate
Buprenorphine Hydrochloride	Buprenorphine Hydrochloride with Naloxone Hydrochloride
Calcium Carbonate	Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Calcium Chloride	Sodium Chloride with Potassium Chloride and Calcium Chloride Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Candesartan Cilexetil	Candesartan Cilexetil with Hydrochlorothiazide
Carbidopa	Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Carbomer 980	Hypromellose with Carbomer 980
Cefaclor Monohydrate	Cefaclor Monohydrate with Water - Purified BP
Cephalexin	Cephalexin with Water - Purified BP
Chlorhexidine Gluconate	Silver Sulfadiazine with Chlorhexidine Gluconate
Codeine Phosphate	Codeine Phosphate with Paracetamol
Colecalciferol	Alendronate Sodium with Colecalciferol
Dexamethasone Sodium Metasulfobenzoate	Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Dextran 70	Hypromellose 2900 with Dextran 70 Hypromellose 4500 with Dextran 70
Diphenoxylate Hydrochloride	Diphenoxylate Hydrochloride with Atropine Sulfate
Dipyridamole	Dipyridamole with Aspirin
Dorzolamide Hydrochloride	Dorzolamide Hydrochloride with Timolol Maleate
Dydrogesterone	Oestradiol with Dydrogesterone
Eformoterol Fumarate Dihydrate	Budesonide with Eformoterol Fumarate Dihydrate
Emtricitabine	Tenofovir Disoproxil Fumarate with Emtricitabine
Enalapril Maleate	Enalapril Maleate with Hydrochlorothiazide
Entacapone	Levodopa with Carbidopa and Entacapone
Eprosartan Mesylate	Eprosartan Mesylate with Hydrochlorothiazide
Erythromycin Ethyl Succinate	Erythromycin Ethyl Succinate with Water - Purified BP
Ethinyloestradiol	Levonorgestrel with Ethinyloestradiol Norethisterone with Ethinyloestradiol
Ezetimibe	Ezetimibe with Simvastatin
Ferrous Fumarate	Ferrous Fumarate with Folic Acid
Flucloxacillin Magnesium	Flucloxacillin Magnesium with Water - Purified BP
Fluticasone Propionate	Fluticasone Propionate with Salmeterol Xinafoate
Folic Acid	Ferrous Fumarate with Folic Acid
Fosinopril Sodium	Fosinopril Sodium with Hydrochlorothiazide
Framycetin Sulfate	Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Frangula Bark	Sterculia with Frangula Bark
Glibenclamide	Metformin Hydrochloride with Glibenclamide
Glucose	Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate Sodium Chloride with Glucose
Gramicidin	Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Hydrochlorothiazide	Candesartan Cilexetil with Hydrochlorothiazide
Enalapril Maleate with Hydrochlorothiazide
Eprosartan Mesylate with Hydrochlorothiazide
Fosinopril Sodium with Hydrochlorothiazide
Hydrochlorothiazide with Amiloride Hydrochloride
Hydrochlorothiazide with Triamterene
Irbesartan with Hydrochlorothiazide
Quinapril Hydrochloride with Hydrochlorothiazide
Telmisartan with Hydrochlorothiazide
Hypromellose	Hypromellose with Carbomer 980
Hypromellose 2900	Hypromellose 2900 with Dextran 70
Hypromellose 4500	Hypromellose 4500 with Dextran 70
Indapamide Hemihydrate	Perindopril Erbumine with Indapamide Hemihydrate
Insulin 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 Sulfate with Lamivudine Abacavir Sulfate with Lamivudine and Zidovudine Lamivudine with Zidovudine
Latanoprost	Latanoprost with Timolol Maleate
Levodopa	Levodopa with Benserazide Hydrochloride Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Levonorgestrel	Levonorgestrel with Ethinyloestradiol
Lopinavir	Lopinavir with Ritonavir
Macrogol 3350	Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Magnesium Chloride	Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Magnesium Hydroxide	Aluminium Hydroxide - Dried with Magnesium Hydroxide Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Magnesium Trisilicate	Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide
Medroxyprogesterone Acetate	Oestrogens—Conjugated with Medroxyprogesterone Acetate
Mestranol	Norethisterone with Mestranol
Metformin Hydrochloride	Metformin Hydrochloride with Glibenclamide Rosiglitazone Maleate with Metformin Hydrochloride
Mycophenolate Mofetil	Mycophenolate Mofetil with Water - Purified BP
Naloxone Hydrochloride	Buprenorphine Hydrochloride with Naloxone Hydrochloride
Neomycin Sulfate	Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Neomycin Undecenoate	Neomycin Undecenoate with Bacitracin Zinc
Norethisterone	Norethisterone with Ethinyloestradiol Norethisterone with Mestranol
Norethisterone Acetate	Oestradiol Hemihydrate with Norethisterone Acetate Oestradiol with Norethisterone Acetate
Nystatin	Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Oestradiol	Oestradiol with Dydrogesterone Oestradiol with Norethisterone Acetate
Oestradiol Hemihydrate	Oestradiol Hemihydrate with Norethisterone Acetate
Oestrogens—Conjugated	Oestrogens—Conjugated with Medroxyprogesterone Acetate
Paracetamol	Codeine Phosphate with Paracetamol
Paraffin - Liquid	Paraffin - Soft White with Paraffin - Liquid
Paraffin - Soft White	Paraffin - Soft White with Paraffin - Liquid
Perindopril Erbumine	Perindopril Erbumine with Indapamide Hemihydrate
Phenylephrine Hydrochloride	Prednisolone Acetate with Phenylephrine Hydrochloride
Polyethylene Glycol 400	Polyethylene Glycol 400 with Propylene Glycol
Potassium Bicarbonate	Potassium Chloride with Potassium Bicarbonate
Potassium Chloride	Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Potassium Chloride with Potassium Bicarbonate
Sodium Chloride with Potassium Chloride and Calcium Chloride
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Potassium Clavulanate	Amoxycillin Trihydrate with Potassium Clavulanate Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP Ticarcillin Sodium with Potassium Clavulanate
Prednisolone Acetate	Prednisolone Acetate with Phenylephrine Hydrochloride
Propylene Glycol	Polyethylene Glycol 400 with Propylene Glycol
Quinapril Hydrochloride	Quinapril Hydrochloride with Hydrochlorothiazide
Ritonavir	Lopinavir with Ritonavir
Rosiglitazone Maleate	Rosiglitazone Maleate with Metformin Hydrochloride
Salmeterol Xinafoate	Fluticasone Propionate with Salmeterol Xinafoate
Silver Sulfadiazine	Silver Sulfadiazine with Chlorhexidine Gluconate
Simvastatin	Ezetimibe with Simvastatin
Sodium Acetate	Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Acid Citrate	Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Sodium Alginate	Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Sodium Bicarbonate	Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Sodium Chloride	Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sodium Chloride with Glucose
Sodium Chloride with Potassium Chloride and Calcium Chloride
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Sodium Citrate	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sodium Gluconate	Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Sodium Lactate	Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
Sodium Lauryl Sulfoacetate	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sorbitol	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Stavudine	Stavudine with Water - Purified BP
Sterculia	Sterculia with Frangula Bark
Sulfamethoxazole	Trimethoprim with Sulfamethoxazole
Telmisartan	Telmisartan with Hydrochlorothiazide
Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate with Emtricitabine
Testosterone Decanoate	Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Testosterone Isocaproate	Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Testosterone Phenylpropionate	Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Testosterone Propionate	Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Ticarcillin Sodium	Ticarcillin Sodium with Potassium Clavulanate
Timolol Maleate	Brimonidine Tartrate with Timolol Maleate
Dorzolamide Hydrochloride with Timolol Maleate
Latanoprost with Timolol Maleate
Travoprost with Timolol Maleate
Travoprost	Travoprost with Timolol Maleate
Triamcinolone Acetonide	Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Triamterene	Hydrochlorothiazide with Triamterene
Trimethoprim	Trimethoprim with Sulfamethoxazole
Water - Purified BP	Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Amoxycillin Trihydrate with Water - Purified BP
Azithromycin Dihydrate with Water - Purified BP
Cefaclor Monohydrate with Water - Purified BP
Cephalexin with Water - Purified BP
Erythromycin Ethyl Succinate with Water - Purified BP
Flucloxacillin Magnesium with Water - Purified BP
Mycophenolate Mofetil with Water - Purified BP
Stavudine with Water - Purified BP
Zidovudine	Abacavir Sulfate with Lamivudine and Zidovudine Lamivudine with Zidovudine

Acacia BP, powdered	—
Acetic Acid (33 per cent) BP	—
Alum BP	—
Aluminium Acetate Solution BP	—
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

Pholcodine Citrate Syrup BPC 1959

Sodium Thiosulfate BP

Abacavir Sulfate

Abacavir Sulfate with Lamivudine

Abacavir Sulfate with Lamivudine and Zidovudine

Adefovir Dipivoxil

Apomorphine Hydrochloride

Atazanavir Sulfate

Bosentan Monohydrate

Botulinum Toxin Type A Purified Neurotoxin Complex

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride with Naloxone Hydrochloride

Charcoal - Activated

Choriogonadotropin Alfa

Cidofovir

Clostridium Botulinum Type A Toxin—Haemagglutinin Complex

Clozapine

Darbepoetin Alfa

Deferasirox

Deferiprone

Delavirdine Mesylate

Desferrioxamine Mesylate

Didanosine

Dornase Alfa

Efavirenz

Emtricitabine

Enfuvirtide

Entecavir Monohydrate

Epoetin Alfa

Epoetin Beta

Epoprostenol Sodium

Filgrastim

Fosamprenavir Calcium

Foscarnet Sodium

Ganciclovir

Ganciclovir Sodium

Iloprost Trometamol

Imatinib Mesylate

Indinavir Sulfate

Infliximab

Interferon Gamma-1b

Lamivudine

Lamivudine with Zidovudine

Lanreotide Acetate

Lenograstim

Lopinavir with Ritonavir

Nelfinavir Mesylate

Nevirapine

Octreotide Acetate

Pegfilgrastim

Peginterferon Alfa-2a

Peginterferon Alfa-2b

Progesterone

Ribavirin and Peginterferon Alfa-2a

Ribavirin and Peginterferon Alfa-2b

Rifabutin

Ritonavir

Saquinavir Mesylate

Sildenafil Citrate

Somatropin

Stavudine

Stavudine with Water - Purified BP

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate with Emtricitabine

Thalidomide

Trastuzumab

Valganciclovir Hydrochloride

Zidovudine

Zoledronic Acid

Dated this 12 day of March 2007.

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Delegate of the Minister for Health and Ageing