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PB 32 of 2007 Declarations/Other as made
This Declaration changes the list of drugs and medicinal preparations available as pharmaceutical benefits as recommended by the Pharmaceutical Benefits Advisory Committee.
Administered by: Health
Registered 04 Apr 2007
Tabling HistoryDate
Tabled HR08-May-2007
Tabled Senate09-May-2007
Date of repeal 01 Jul 2007
Repealed by National Health Act 1953 - Declaration under subsection 85(2) (No. PB 43 of 2007)

COMMONWEALTH OF AUSTRALIA

National Health Act 1953

PHARMACEUTICAL BENEFITS

DECLARATION UNDER SUBSECTION 85(2)

No. PB 32 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 May 2007.

2.          Declaration No. PB 21 of 2007 under subsection 85(2) of the National Health Act 1953 made on 
12 March 2007 with effect from 1 April 2007 is repealed.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


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 a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

 

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

 

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and

 

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

 

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

 

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

 

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

 

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis 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;

 

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

 

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 subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (ii):

Initial treatment by an ophthalmologist, as the sole subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS-subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic, is submitted to the Medicare Australia CEO by facsimile prior to contact by telephone and is resubmitted to the Medicare Australia CEO by post after the application has been authorised

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment by an ophthalmologist, as the sole 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):

Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person

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

 

(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 demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:

 

(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or

 

(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;

 

a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;

 

the most recent PASI assessment is no more than 1 month old at the time of application;

 

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;

 

if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

 

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 

(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

 

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

 

(iii) 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 of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with 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 of the face, or palm of a hand or sole of a foot; and

 

(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and

 

(c) have not failed PBS-subsidised therapy with 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 face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

 

(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;

 

a course of initial treatment within 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 of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

 

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:

 

(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with efalizumab prior to 10 November 2005; and

 

(b) whose disease, prior to treatment with efalizumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and

 

(c) who have signed a patient 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) who 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 face, hand, foot 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 PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

 

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 of the face, or palm of a hand or sole of a foot, 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 of the face, or palm of a hand or sole of a foot; and

 

(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with 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 the plaque or plaques assessed prior to biological agent treatment showing:

 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline values established prior to biological agent treatment; or

 

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline value 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 face, hand, foot 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 of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with 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

Eformoterol Fumarate Dihydrate

Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids

Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids

"EleCare"

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

 

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

 

Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

 

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

 

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Enalapril Maleate

Enalapril Maleate with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with 20 mg enalapril maleate

"Energivit"

Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae

Enoxaparin Sodium

Entacapone

In compliance with authority procedures set out in subparagraph 14 (d):

Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect

Epirubicin Hydrochloride

Eplerenone

In compliance with authority procedures set out in subparagraph 14 (d):

Initial therapy subsidised under the Pharmaceutical Benefits Scheme (PBS) for heart failure with a left ventricular ejection fraction of 40% or less occurring within 3 to 14 days following an acute myocardial infarction, where the date of the acute myocardial infarction is included in the authority application, and where the treatment commences within 14 days of the acute myocardial infarction or continues treatment which was commenced in a hospital within 14 days of the acute myocardial infarction

Continuation of therapy for heart failure with a left ventricular ejection fraction of 40% or less occurring following an acute myocardial infarction, where the patient has previously been issued with a PBS authority prescription for eplerenone

Eprosartan Mesylate

Eprosartan Mesylate with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy

Eptifibatide Acetate

In compliance with authority procedures set out in subparagraph 14 (d):

Patients undergoing non-urgent percutaneous intervention with intracoronary stenting

Erythromycin

Erythromycin Ethyl Succinate

Erythromycin Ethyl Succinate with Water - Purified BP

Erythromycin Lactobionate

Escitalopram Oxalate

In respect of the tablet equivalent to 10 mg escitalopram and tablet equivalent to 20 mg escitalopram:

 

Major depressive disorders

 

In respect of the oral solution equivalent to 10 mg escitalopram per mL, 28 mL:

 

Major depressive disorders

 

In compliance with authority procedures set out in subparagraph 14 (d):

Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance

 

Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences

Esomeprazole Magnesium Trihydrate

In respect of the tablet (enteric coated), equivalent to 20 mg esomeprazole:

 

Initial treatment of gastric ulcer

 

Maintenance of healed gastro-oesophageal reflux disease

 

In respect of the tablet (enteric coated), equivalent to 40 mg esomeprazole:

 

Healing of gastro-oesophageal reflux disease

Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate

Eradication of Helicobacter pylori associated with peptic ulcer disease

Etanercept

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment 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 12 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with etanercept 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 etanercept 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 etanercept 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 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;

 

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 

(i) 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 12 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 etanercept 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 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 etanercept 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 etanercept prior to 16 March 2006; and

 

(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with etanercept; 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 etanercept; 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 etanercept 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 12 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 etanercept prior to 16 March 2006, 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 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 etanercept; and

 

(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; 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 etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of etanercept 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 the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;

 

patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment;

 

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 12 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 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

 

(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 demonstrable in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:

 

(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or

 

(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;

 

a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;

 

the most recent PASI assessment is no more than 1 month old at the time of application;

 

if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;

 

if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

 

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 

(i) copies of the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

 

(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

 

(iii) a copy of the signed patient acknowledgement form;

 

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 12 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 of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with etanercept 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 of the face, or palm of a hand or sole of a foot; and

 

(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and

 

(c) have not failed PBS-subsidised therapy with etanercept 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 etanercept 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 12-week course of PBS-subsidised etanercept treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;

 

the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 

(i) a copy of the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

 

(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;

 

a course of initial treatment within a Treatment Cycle is limited to a maximum of 12 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 etanercept 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 of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 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 etanercept 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:

 

(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with etanercept prior to 16 March 2006; and

 

(b) whose disease, prior to treatment with etanercept, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and

 

(c) who have signed a patient 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) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with etanercept; 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 face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of etanercept 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 PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;

 

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 12 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 of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with etanercept prior to 16 March 2006, 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 12 weeks, and where approval of the application would enable the patient to complete a course of 12 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 of the face, or palm of a hand or sole of a foot; and

 

(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and

 

(c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and

 

where biological agent means 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 etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:

 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline values established prior to biological agent treatment; or

 

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of etanercept treatment, as compared to the baseline value 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 the assessment of response is conducted at the completion of the 12-week treatment course and is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;

 

patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept are not eligible to commence further treatment with etanercept until they have completed a period free from biological agent therapy of at least 12 weeks duration, immediately following cessation of that course of treatment;

 

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 face, hand, foot 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 12 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 of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 12 weeks, and where approval of the application would enable the patient to complete a course of 12 weeks of treatment in total

 

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

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and

 

where bDMARD means a drug included in the following list of drugs:

 

adalimumab, anakinra, etanercept or infliximab; and

 

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

 

patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;

 

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if:

 

(i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and

 

(ii) the response was assessed, and the assessment was provided to the 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 etanercept therapy;

 

a course of treatment is limited to a maximum of 16 weeks of treatment

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, 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):

Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and

 

where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and

 

where the following conditions apply:

 

failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list:

 

— elbow, wrist, knee or ankle (assessed as swollen and tender);

 

— shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

 

if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

 

the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment;

 

where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and

 

where bDMARD means a drug included in the following list of drugs:

 

adalimumab, anakinra, etanercept or infliximab; and

 

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;

 

the course of treatment is limited to a maximum of 24 weeks of treatment

 

Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and:

 

(a) who have demonstrated an adequate response to treatment with etanercept; and

 

(b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and

 

where bDMARD means a drug included in the following list of drugs:

 

adalimumab, anakinra, etanercept or infliximab; and

 

where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;

 

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

 

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

 

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

 

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

 

the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

 

if the most recent course of etanercept therapy was 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, 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 PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient

 

Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%:

 

— elbow, wrist, knee or ankle (assessed as swollen and tender);

 

— shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and

 

where the following conditions apply:

 

the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient;

 

patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment;

 

authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course

 

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

 

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

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and

 

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 

where the following conditions apply:

 

a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 

the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

 

the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

 

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

 

(b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 

(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 

if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

 

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

 

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 etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and

 

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 

where the following conditions apply:

 

a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 

response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:

 

(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

 

(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

 

(c) an ESR or CRP measurement reduced by at least 20% from baseline;

 

if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

 

(a) an ESR measurement no greater than 25 mm per hour; or

 

(b) a CRP measurement no greater than 10 mg per L;

 

all measurements provided are no more than 1 month old at the time of application;

 

the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;

 

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

 

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 

(b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 

(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 

the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;

 

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment

 

In compliance with authority procedures set out in subsubparagraph 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 etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

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 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

 

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

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

 

(1) have a documented history of severe active psoriatic arthritis 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 etanercept during the current Treatment Cycle; and

 

where biological agent means adalimumab or etanercept or infliximab; and

 

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

 

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

 

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and

 

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

 

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

 

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

 

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

 

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis 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

 

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 etanercept for continuing treatment, by a rheumatologist or by an 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 etanercept prior to 17 March 2005; and

 

(3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and

 

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

 

where biological agent means adalimumab or etanercept or infliximab; and

 

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form;

 

the course of treatment is limited to a maximum of 24 weeks of treatment;

 

patients are eligible for PBS-subsidised treatment under the above criteria once only

 

In compliance with authority procedures set out in subsubparagraph 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 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 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 etanercept; and

 

(3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and

 

where biological agent means adalimumab or etanercept or infliximab; and

 

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 

where the following conditions apply:

 

an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

 

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

 

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

 

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

 

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

 

if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

 

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment

 

In compliance with authority procedures set out in subsubparagraph 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

Ethacrynic Acid

Patients hypersensitive to other oral diuretics

Ethosuximide

Etonogestrel

Etoposide

Etoposide Phosphate

Everolimus

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Exemestane

Treatment of hormone-dependent advanced breast cancer in post-menopausal women with disease progression following treatment with tamoxifen citrate

Treatment of hormone-dependent early breast cancer in post-menopausal women following a minimum of 2 years' treatment with tamoxifen citrate

Ezetimibe

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease whose cholesterol levels are inadequately controlled with a statin, and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with a statin, and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with a statin, and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with a statin, and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment in conjunction with dietary therapy and exercise, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with symptomatic cerebrovascular disease whose cholesterol levels are inadequately controlled with a statin, and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Continuing treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia or symptomatic cerebrovascular disease whose cholesterol levels were inadequately controlled with a statin, where the patient has previously been issued with an authority prescription for this drug

 

For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated

 

For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is unsuitable because the patient developed a clinically important product-related adverse event during treatment with a statin and required discontinuation of all statin treatment, and where a clinically important product-related adverse event is defined as follows:

 

 Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

 

 Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or

 

 Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin

 

Homozygous sitosterolaemia

 

For use in accordance with paragraph 16, in combination with an HMG CoA reductase inhibitor (statin), in patients with homozygous familial hypercholesterolaemia

Ezetimibe with Simvastatin

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, in conjunction with dietary therapy and exercise, of patients with coronary heart disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment, in conjunction with dietary therapy and exercise, of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment, in conjunction with dietary therapy and exercise, of patients with peripheral vascular disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment, in conjunction with dietary therapy and exercise, of patients with heterozygous familial hypercholesterolaemia whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Initial treatment, in conjunction with dietary therapy and exercise, of patients with symptomatic cerebrovascular disease whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin), and where:

 

 (a) inadequate control with a statin is defined as:

 

 (i) in the case of patients who fall into a category specified in subparagraph 16(a) — a cholesterol level greater than 4 mmol per L, after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; or

 

 (ii) in the case of patients who fall into a category specified in subparagraph 16(b) — a cholesterol level as specified for that category of patient in the table included in subparagraph 16(b), after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater in conjunction with dietary therapy and exercise; and

 

 (b) the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application; and

 

 (c) the cholesterol level results provided are no more than 2 months old at the time of application

 

Continuing treatment of patients with coronary heart disease or diabetes mellitus or peripheral vascular disease or heterozygous familial hypercholesterolaemia or symptomatic cerebrovascular disease whose cholesterol levels were inadequately controlled with an HMG CoA reductase inhibitor (statin), where the patient has previously been issued with an authority prescription for ezetimibe with simvastatin or for ezetimibe used concurrently with 40 mg or greater of a statin

 

For use in accordance with paragraph 16 in patients with homozygous familial hypercholesterolaemia

 

 

 

Famciclovir

In respect of the tablet 125 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

 

In respect of the tablet 250 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of patients with herpes zoster within 72 hours of the onset of the rash

 

Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

 

In respect of the tablet 500 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of immunocompromised patients with herpes zoster within 72 hours of the onset of the rash

 

Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

 

Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

 

Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

 

Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

Famotidine

Felodipine

Fenofibrate

For use in accordance with paragraph 16

Fentanyl

Chronic severe disabling pain not responding to non-narcotic analgesics

Ferrous Fumarate with Folic Acid

Ferrous Sulfate

Flecainide Acetate

Serious supra-ventricular cardiac arrhythmias

Serious ventricular cardiac arrhythmias where treatment is initiated in a hospital (in-patient or out-patient)

Flucloxacillin Magnesium with Water - Purified BP

Serious staphylococcal infections

Flucloxacillin Sodium

In respect of the 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:

 

Fluconazole

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of cryptococcal meningitis in patients unable to take or tolerate amphotericin

 

Maintenance therapy in patients with cryptococcal meningitis and immunosuppression

 

Treatment of oropharyngeal candidiasis in immunosuppressed patients

 

Treatment of oesophageal candidiasis in immunosuppressed patients

 

Secondary prophylaxis of oropharyngeal candidiasis in immunosuppressed patients

 

Treatment of serious and life-threatening candida infections in patients unable to tolerate amphotericin

Fludrocortisone Acetate

Fluorometholone

Fluorometholone Acetate

Fluorouracil

Fluoxetine Hydrochloride

Major depressive disorders

Obsessive-compulsive disorder

Flupenthixol Decanoate

Fluphenazine Decanoate

Flurbiprofen Sodium

Flutamide

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy

Fluticasone Propionate

Fluticasone Propionate with Salmeterol Xinafoate

Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate

Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate

Fluvastatin Sodium

For use in accordance with paragraph 16

Fluvoxamine Maleate

Major depressive disorders

Obsessive-compulsive disorder

Folic Acid

Follitropin Alfa

In respect of the injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL and injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL:

 

Anovulatory infertility

 

In respect of the injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL, injection 300 I.U. in 0.5 mL multi-dose cartridge, injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL, injection 450 I.U. in 0.75 mL multi-dose cartridge and injection 900 I.U. in 1.5 mL multi-dose cartridge:

 

Anovulatory infertility

 

In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis

Follitropin Beta

Anovulatory infertility

In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis

Fondaparinux Sodium

In compliance with authority procedures set out in subparagraph 14 (d):

Prevention of venous thromboembolic events in patients undergoing major hip surgery

Prevention of venous thromboembolic events in patients undergoing total knee replacement

Fosinopril Sodium

Fosinopril Sodium with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or fosinopril sodium monotherapy

Fotemustine

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic malignant melanoma

Framycetin Sulfate

Frusemide

Gabapentin

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs

Galantamine Hydrobromide

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

Gefitinib

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment subsidised under the Pharmaceutical Benefits Scheme (PBS), as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation (WHO) performance status of 2 or less, and:

 

(a) in whom disease progression has occurred following treatment with at least 1 chemotherapy agent; and

 

(b) where there is evidence that the patient has at least 1 activating mutation of the epidermal growth factor receptor (EGFR) gene in tumour material, unless:

 

(i) the patient commenced treatment with gefitinib prior to 1 July 2004, in which case, although an attempt must be made to test for the presence of an activating mutation of the EGFR gene, the patient is exempt from meeting this requirement; or

 

(ii) the patient commenced treatment with gefitinib between 1 July 2004 and 27 September 2004, in which case a test for the presence of an activating mutation of the EGFR gene with a negative result does not render the patient ineligible if a radiological assessment of the patient which is less than 1 month old at the date of the authority application demonstrates that disease progression has not occurred while the patient has been on gefitinib therapy; and

 

where the following conditions apply:

 

the presence of a mutation is demonstrated by analysis of the DNA sequence of the EGFR gene;

 

the authority application includes the following:

 

(i) a completed copy of the appropriate Gefitinib (Iressa) PBS Authority Application - Supporting Information Form; and

 

(ii) details of the prior chemotherapy including the names of drugs and date of the most recent treatment cycle; and

 

(iii) details of the patient's WHO performance status; and

 

(iv) a copy of the pathology report from an Approved Pathology Authority providing the result of the test for the presence of an activating mutation, or mutations, of the EGFR gene; and

 

(v) where the patient is claiming exemption from the requirement to test positive for the presence of an activating mutation of the EGFR gene on the basis that treatment with gefitinib commenced between 1 July 2004 and 27 September 2004 and a radiological assessment within the month prior to the application shows disease progression has not occurred while on gefitinib therapy, a copy of that radiological assessment

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib

Gelatin - Succinylated

Gemcitabine Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline

 

Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy

 

Locally advanced or metastatic non-small cell lung cancer

 

Locally advanced or metastatic adenocarcinoma of the pancreas

 

Locally advanced or metastatic bladder cancer, when used in combination with cisplatin

Gemfibrozil

For use in accordance with paragraph 16

Gentamicin Sulfate

In respect of the injection equivalent to 80 mg gentamicin in 2 mL ampoule:

 

 

In respect of the eye drops equivalent to 3 mg gentamicin per mL, 5 mL:

 

Invasive ocular infection

 

Perioperative use in ophthalmic surgery

 

Suspected pseudomonal eye infection

Gestrinone

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy

Glatiramer Acetate

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient

Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy

Glibenclamide

Gliclazide

Glimepiride

Glipizide

Glucagon Hydrochloride

Glucose

Glucose and Ketone Indicator—Urine

Glucose Indicator—Blood

In respect of the electrode strips, 50 (Accu-Chek Performa), electrode strips, 50 (Advantage II), electrode strips, 50 (Freestyle Papillon), electrode strips, 50 (Glucocard 01 Sensor), electrode strips, 50 (GlucoCare), electrode strips, 50 (GlucoCare Super Sensor), electrode strips, 50 (GlucoMen Sensor), electrode strips, 50 (MWD Pen Sensor Strips), electrode strips, 50 (Omnitest EZ), electrode strips, 50 (Omnitest Plus), electrode strips, 50 (Touch-In Plus), electrode strips, 50 (TrueTrack), discs containing electrode sensors, 10 sensors per disc, 5, electrode strips, 100 (Optium glucose), electrode strips, 100 (SofTact), electrode strips, 100 (TrueSense), reagent strips, 50 (Accu-Chek Active), reagent strips, 50 (Accu-Chek Go), reagent strips, 51 (Accu-Chek Integra), reagent strips, 50 (Betachek), reagent strips, 50 (Betachek G5), reagent strips, 50 (CareSens), reagent strips, 50 (Glucoflex-R), reagent strips, 50 (Glucostix) and reagent strips, 50 (SensoCard):

 

 

In respect of the electrode strips, 50 (Ascensia Elite) and electrode strips, 100 (Precision Plus):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Patients who have previously received this product as a pharmaceutical benefit

 

Patients who have purchased a meter to be used with this product prior to 1 August 2003

Glucose Indicator—Urine

Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate

Glycerol

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

Glyceryl Trinitrate

Goserelin Acetate

In respect of the subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

 

Hormone-dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre-menopausal women

 

Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy

 

In respect of the subcutaneous implant (long acting) equivalent to 10.8 mg goserelin in pre-filled injection syringe:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

Goserelin Acetate and Bicalutamide

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic (equivalent to stage D) prostatic carcinoma in patients for whom a combination of an antiandrogen and a gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist is required

Granisetron Hydrochloride

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with radiotherapy being used to treat malignancy

Griseofulvin

Haloperidol

Haloperidol Decanoate

"HCU express"

Pyridoxine non-responsive homocystinuria

"HCU gel"

Pyridoxine non-responsive homocystinuria

Heparin Sodium

Hexamine Hippurate

Homatropine Hydrobromide

Hydralazine Hydrochloride

Hydrochlorothiazide

Hydrochlorothiazide with Amiloride Hydrochloride

Hydrochlorothiazide with Triamterene

Hydrocortisone

In respect of the tablet 4 mg and tablet 20 mg:

 

 

In respect of the cream 10 mg per g, 50 g:

 

Treatment of corticosteroid-responsive dermatoses

 

Hydrocortisone Acetate

In respect of the eye ointment 5 mg per g, 5 g and eye ointment 10 mg per g, 5 g:

 

 

In respect of the cream 10 mg per g, 30 g, cream 10 mg per g, 50 g, ointment 10 mg per g, 30 g and ointment 10 mg per g, 50 g:

 

Treatment of corticosteroid-responsive dermatoses

 

In respect of the rectal foam 90 mg per applicatorful, 14 applications, aerosol 21.1 g:

 

Proctitis

 

Ulcerative colitis

Hydrocortisone Sodium Succinate

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, injection 50 mg in 5 mL ampoule and injection 500 mg in 50 mL vial:

 

Hydroxocobalamin

Pernicious anaemia

Other proven vitamin B12 deficiencies

Prophylaxis after gastrectomy

Hydroxocobalamin Acetate

Pernicious anaemia

Other proven vitamin B12 deficiencies

Prophylaxis after gastrectomy

Hydroxychloroquine Sulfate

Hydroxyurea

Hypromellose

Severe dry eye syndrome, including Sjogren's syndrome

Hypromellose 2900 with Dextran 70

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

Hypromellose 4500 with Dextran 70

Severe dry eye syndrome, including Sjogren's syndrome

Hypromellose with Carbomer 980

Severe dry eye syndrome, including Sjogren's syndrome

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:

 

Idarubicin Hydrochloride

Acute myelogenous leukaemia

Ifosfamide

Relapsed or refractory germ cell tumours following first-line chemotherapy

Relapsed or refractory sarcomas following first-line chemotherapy

Imipramine Hydrochloride

Imiquimod

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of biopsy confirmed primary (previously untreated) superficial basal cell carcinoma in immunocompetent patients who cannot have surgical excision, cryotherapy, or curettage with diathermy, and where the date of the pathology report and name of the Approved Pathology Authority are included in the authority application

Indapamide Hemihydrate

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:

 

Influenza Vaccine (Split Virion) - Inactivated

Persons at special risk of adverse consequences from infections of the lower respiratory tract

Insect Allergen Extract—Honey Bee Venom

Insect Allergen Extract—Paper Wasp Venom

Insect Allergen Extract—Yellow Jacket Venom

Insulin Aspart

Insulin Aspart with Insulin Aspart Protamine Suspension

Insulin Detemir

Type 1 diabetes

Insulin Glargine

Insulin - Isophane

Insulin Lispro

Insulin Lispro with Insulin Lispro Protamine Suspension

Insulin - Neutral

Insulin - Neutral with Insulin - Isophane

Interferon Alfa-2a

In respect of the injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Hairy cell leukaemia

 

Myeloproliferative disease with excessive thrombocytosis

 

Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy

 

In respect of the injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe, injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe and injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Myeloproliferative disease with excessive thrombocytosis

 

Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy

Interferon Alfa-2b

In respect of the solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Hairy cell leukaemia

 

Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy

 

Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy

 

In respect of the solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy

 

Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy

Interferon Beta-1a

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient

Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy

Interferon Beta-1b

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient

Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy

Ipratropium Bromide

In respect of the pressurised inhalation 21 micrograms per dose, 200 doses (CFC-free formulation):

 

 

In respect of the nebuliser solution 250 micrograms (anhydrous) in 1 mL single dose units, 30, nebuliser solution 500 micrograms (anhydrous) in 1 mL single dose units, 30 and nebuliser solution 250 micrograms (anhydrous) per mL, 20 mL:

 

Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer

 

Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer

Irbesartan

Irbesartan with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or irbesartan monotherapy

Irinotecan Hydrochloride Trihydrate

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less

Iron Polymaltose Complex

Iron Sucrose

In compliance with authority procedures set out in subparagraph 14 (d):

Iron deficiency anaemia, when used in combination with either epoetin alfa or darbepoetin alfa, in patients undergoing chronic haemodialysis who have had a documented hypersensitivity reaction to iron polymaltose and in whom continued intravenous iron therapy is appropriate

Isoniazid

Isosorbide Dinitrate

Isosorbide Mononitrate

Isotretinoin

In compliance with authority procedures set out in subparagraph 14 (d):

Severe cystic acne not responsive to other therapy

Itraconazole

In compliance with authority procedures set out in subparagraph 14 (d):

Systemic aspergillosis

 

Systemic sporotrichosis

 

Systemic histoplasmosis

 

Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have disseminated pulmonary histoplasmosis infection

 

Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have chronic pulmonary histoplasmosis infection

 

Treatment of oropharyngeal candidiasis in immunosuppressed patients

 

Treatment of oesophageal candidiasis in immunosuppressed patients

Ivermectin

In compliance with authority procedures set out in subparagraph 14 (d):

Onchocerciasis

Strongyloidiasis

"Karicare De-Lact"

In compliance with authority procedures set out in subparagraph 14 (d):

Acute lactose intolerance in patients up to the age of 12 months, 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 patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven 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

Ketoconazole

In respect of the tablet 200 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy

 

Oral candidiasis in severely immunocompromised persons where topical therapy has failed

 

Systemic or deep mycoses where other forms of therapy have failed

 

In respect of the cream 20 mg per g, 30 g, shampoo 10 mg per g, 100 mL and shampoo 20 mg per g, 60 mL:

 

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

"Ketonex-1"

Maple syrup urine disease

"Ketonex-2"

Maple syrup urine disease

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:

 

"Kindergen"

In compliance with authority procedures set out in subparagraph 14 (d):

Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet

Labetalol Hydrochloride

Lactulose

Hepatic coma or precoma (chronic porto-systemic encephalopathy)

Constipation in patients with malignant neoplasia

Lamotrigine

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs

Lansoprazole

In respect of the capsule 30 mg:

 

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

In respect of the sachet containing granules for oral suspension, 30 mg per sachet:

 

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor

 

Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor

 

Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor

 

In respect of the capsule 15 mg:

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

Latanoprost

Latanoprost 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 or latanoprost eye drops

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 or latanoprost eye drops

Leflunomide

In respect of the pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician

 

In respect of the tablet 10 mg and tablet 20 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician

 

Ongoing leflunomide therapy for severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective

Lercanidipine Hydrochloride

Letrozole

Treatment of hormone-dependent breast cancer in post-menopausal women

Leuprorelin Acetate

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

Levetiracetam

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs

 

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme

 

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance

 

Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences

Levobunolol Hydrochloride

Levodopa with Benserazide Hydrochloride

Levodopa with Carbidopa

In respect of the tablet 200 mg-50 mg (anhydrous) (modified release):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Parkinson's disease where fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor

 

In respect of the tablet 100 mg-25 mg (anhydrous) and tablet 250 mg-25 mg (anhydrous):

 

Levodopa with Carbidopa and Entacapone

In compliance with authority procedures set out in subparagraph 14 (d):

Parkinson's disease in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect

Parkinson's disease in patients stabilised on concomitant treatment with levodopa—decarboxylase inhibitor combinations and entacapone

Levonorgestrel

In respect of the tablets 30 micrograms, 28:

 

 

In respect of the intrauterine drug delivery system 52 mg:

 

Contraception

Levonorgestrel with Ethinyloestradiol

Lignocaine Hydrochloride

Lincomycin Hydrochloride

Liothyronine Sodium

In compliance with authority procedures set out in subparagraph 14 (d):

Management of patients with thyroid cancer

 

Replacement therapy for hypothyroid patients who have documented intolerance to thyroxine sodium

 

Replacement therapy for hypothyroid patients who have documented resistance to thyroxine sodium

 

Initiation of thyroid therapy in severely hypothyroid patients

Lisinopril

Lithium Carbonate

"Locasol"

In compliance with authority procedures set out in subparagraph 14 (d):

Hypercalcaemia in children under the age of 4 years

Loperamide Hydrochloride

"Lophlex"

Phenylketonuria

"Lophlex LQ"

Phenylketonuria

Lumiracoxib

Symptomatic treatment of osteoarthritis

Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride

Constipation in patients with malignant neoplasia

"Mapleflex"

Maple syrup urine disease

Medroxyprogesterone Acetate

In respect of the tablet 500 mg:

 

Hormone-dependent advanced breast cancer

 

In respect of the tablet 100 mg, tablet 200 mg and tablet 250 mg:

 

Hormone-dependent breast cancer

 

Endometrial cancer

 

In respect of the tablet 5 mg, tablet 10 mg, injection 50 mg in 1 mL vial and injection 150 mg in 1 mL vial:

 

Mefenamic Acid

Dysmenorrhoea

Menorrhagia

Megestrol Acetate

Hormone-dependent advanced breast cancer

Meloxicam

Symptomatic treatment of osteoarthritis

Melphalan

Mercaptopurine

Mesalazine

In respect of the tablet 250 mg (enteric coated) and tablet 500 mg (enteric coated):

 

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

 

Crohn's disease where hypersensitivity to sulfonamides exists

 

Crohn's disease where intolerance to sulfasalazine exists

 

In respect of the sachet containing granules, 500 mg per sachet and sachet containing granules, 1 g per sachet:

 

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

 

In respect of the suppositories 1 g, 28:

 

Acute episode of mild to moderate ulcerative proctitis

 

In respect of the enemas 1 g in 100 mL, 7, enemas 2 g in 60 mL, 7, enemas 4 g in 60 mL, 7 and rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Acute episode of mild to moderate ulcerative colitis

Mesna

Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide

"Metabolic Mineral Mixture"

Metabolic disorders

Metformin Hydrochloride

Metformin Hydrochloride with Glibenclamide

Methadone Hydrochloride

Severe disabling pain not responding to non-narcotic analgesics

Methotrexate

Methyldopa

Methylphenidate Hydrochloride

In respect of the tablet 10 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Use in attention deficit hyperactivity disorder, in accordance with State/Territory law

 

In respect of the tablet 18 mg (extended release), tablet 36 mg (extended release) and tablet 54 mg (extended release):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of attention deficit hyperactivity disorder (ADHD) in a child or adolescent aged between 6 to 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 12 hours

Methylprednisolone Aceponate

In respect of the cream 1 mg per g, 15 g, ointment 1 mg per g, 15 g and fatty ointment 1 mg per g, 15 g:

 

Treatment of corticosteroid-responsive dermatoses

 

In respect of the lotion 1 mg per g, 20 g:

 

Eczema

Methylprednisolone Acetate

For local intra-articular or peri-articular infiltration

Methylprednisolone Sodium Succinate

Methysergide Maleate

Metoclopramide Hydrochloride

Metoprolol Succinate

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

Metoprolol Tartrate

 

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:

 

Prophylaxis in large bowel surgery

 

Treatment, in a hospital, of acute anaerobic sepsis

Metronidazole Benzoate

Mexiletine Hydrochloride

Mianserin Hydrochloride

Severe depression

Miconazole

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

Miconazole Nitrate

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

"Minaphlex"

Phenylketonuria

Minocycline Hydrochloride

In respect of the tablet equivalent to 50 mg minocycline:

 

Severe acne not responding to other tetracyclines

 

In respect of the capsule equivalent to 100 mg minocycline:

 

Minoxidil

In compliance with authority procedures set out in subparagraph 14 (d):

Severe refractory hypertension where treatment with minoxidil was initiated in a hospital (in-patient or out-patient)

Mirtazapine

Major depressive disorders

Misoprostol

In compliance with authority procedures set out in subparagraph 14 (d):

Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and in whom non-steroidal anti-inflammatory drug therapy is essential

 

Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are included in the authority application

 

Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are included in the authority application

Mitozantrone Hydrochloride

Moclobemide

Major depressive disorders

Modafinil

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, by a qualified sleep medicine practitioner or neurologist, of patients with narcolepsy where:

 

(i) intolerance to dexamphetamine sulfate of a severity necessitating permanent treatment withdrawal develops; or

 

(ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following:

 

(a) a psychiatric disorder;

 

(b) a cardiac disorder;

 

(c) a history of substance abuse;

 

(d) glaucoma;

 

(e) any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration-approved Product Information; and

 

where the patient meets the following definition of narcolepsy:

 

excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, and:

 

(i) a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT), conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes; or

 

(ii) a MSLT, conducted following at least 6 hours of sleep, with a mean sleep latency less than or equal to 8 minutes and 2 or more sleep onset rapid eye movement (REM) periods; or

 

(iii) an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; and

 

where the following conditions apply:

 

the MSLT is preceded by nocturnal polysomnography;

 

the polysomnography test and the MSLT are conducted by, or under the supervision of, a qualified sleep medicine practitioner;

 

the EEG is conducted by, or under the supervision of, a neurologist;

 

the authority application includes the following:

 

(a) a completed copy of the appropriate Modafinil (Modavigil) PBS Authority Application - Supporting Information Form; and

 

(b) details of the contraindication or intolerance to dexamphetamine sulfate; and

 

(c) either the result and date of the polysomnography test and the MSLT, or the result and date of the EEG;

 

the polysomnography and MSLT, or the EEG, test reports are provided with the authority application

 

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug

Mometasone Furoate

Treatment of corticosteroid-responsive dermatoses

"Monogen"

Chylous ascites

 

Chylothorax

 

Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders

 

Hyperlipoproteinaemia type 1

 

Long chain fatty acid oxidation disorders

Montelukast Sodium

In respect of the tablet, chewable, equivalent to 4 mg montelukast:

 

In compliance with authority procedures set out in subparagraph 14 (d):

First-line preventer medication, as the single preventer agent for children aged from 2 to less than 6 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium

 

In respect of the tablet, chewable, equivalent to 5 mg montelukast:

 

In compliance with authority procedures set out in subparagraph 14 (d):

First-line preventer medication, as the single preventer agent for children aged from 6 to less than 15 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium

Morphine Hydrochloride

Severe disabling pain not responding to non-narcotic analgesics

Morphine Sulfate

In respect of the tablet 10 mg and tablet 20 mg:

 

Severe disabling pain due to cancer not responding to non-narcotic analgesics

 

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 tablet 200 mg (controlled release) and sachet containing controlled release granules for oral suspension, 200 mg per sachet:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Chronic severe disabling pain due to cancer

 

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:

 

Morphine Tartrate

Moxonidine

Hypertension in patients receiving concurrent antihypertensive therapy

"MSUD AID III"

Maple syrup urine disease

"MSUD Analog"

Maple syrup urine disease

"MSUD Express"

Maple syrup urine disease

"MSUD-gel"

Maple syrup urine disease

"MSUD Maxamaid"

Maple syrup urine disease

"MSUD Maxamum"

Maple syrup urine disease

Mycophenolate Mofetil

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Mycophenolate Mofetil with Water - Purified BP

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Mycophenolate Sodium

In compliance with authority procedures set out in subparagraph 14 (d):

Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate sodium, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application

Nafarelin Acetate

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 6 months, of visually proven endometriosis

Subsequent treatment, for up to 6 months, of visually proven endometriosis, where 2 years or more have elapsed since the end of the previous course and where a recent bone density assessment has been made and where the date of the assessment is included in the authority application

Naloxone Hydrochloride

Naltrexone Hydrochloride

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

Nandrolone Decanoate

In compliance with authority procedures set out in subparagraph 14 (d):

Monotherapy for osteoporosis where other treatment has failed, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient

 

Monotherapy for osteoporosis where other treatment is not tolerated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient

 

Monotherapy for osteoporosis where other treatment is contraindicated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient

 

Patients receiving PBS-subsidised therapy with this drug for osteoporosis prior to 1 February 2004

 

Patients on long-term treatment with corticosteroids

Naproxen

In respect of the tablet 250 mg, tablet 500 mg, tablet 750 mg (sustained release) and tablet 1 g (sustained release):

 

Chronic arthropathies (including osteoarthritis) with an inflammatory component

 

Bone pain due to malignant disease

 

 

 

 

In respect of the oral suspension 125 mg per 5 mL, 474 mL:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Chronic arthropathies (including osteoarthritis) with an inflammatory component in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent

 

Bone pain due to malignant disease in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent

Naproxen Sodium

Chronic arthropathies (including osteoarthritis) with an inflammatory component

Bone pain due to malignant disease

Naratriptan Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated

 

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS-listed drugs

 

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS-listed drugs

 

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS-listed drugs

 

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance

 

Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences

Nedocromil Sodium

"Neocate"

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

 

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

 

Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

 

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

 

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

"Neocate Advance"

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

 

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

 

Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

 

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

 

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Neomycin Sulfate

Neomycin Undecenoate with Bacitracin Zinc

Nicorandil

Nifedipine

Nilutamide

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy

Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in conjunction with surgical orchidectomy

Nitrazepam

Nitrofurantoin

Nizatidine

Norethisterone

Norethisterone with Ethinyloestradiol

Norethisterone with Mestranol

Norfloxacin

In compliance with authority procedures set out in subparagraph 14 (d):

Acute bacterial enterocolitis

Complicated urinary tract infection

Nortriptyline Hydrochloride

Major depression where other antidepressant therapy has failed

Major depression where other antidepressant therapy is contraindicated

Nystatin

In respect of the tablet 500,000 units, capsule 500,000 units and oral suspension 100,000 units per mL, 24 mL:

 

 

In respect of the cream 100,000 units per g, 15 g:

 

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

Oestradiol

In respect of the tablet 2 mg and vaginal tablets 25 micrograms, 15:

 

 

In respect of the transdermal patches 390 micrograms, 8, transdermal patches 2 mg, 4, transdermal patches 2 mg, 8, transdermal patches 585 micrograms, 8, transdermal patches 3.28 mg, 8, transdermal patches 3.8 mg, 4, transdermal patches 4 mg, 8, transdermal patches 780 micrograms, 8, transdermal patches 4.33 mg, 8, transdermal patches 5.7 mg, 4, transdermal patches 1.17 mg, 8, transdermal patches 6.57 mg, 8, transdermal patches 7.6 mg, 4, transdermal patches 8 mg, 8, transdermal patches 1.56 mg, 8 and transdermal patches 8.66 mg, 8:

 

For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens

Oestradiol and Oestradiol with Dydrogesterone

Oestradiol and Oestradiol with Norethisterone Acetate

In respect of the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg:

 

 

In respect of the pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg:

 

For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens

Oestradiol Hemihydrate

For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens

Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate

For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens

Oestradiol Hemihydrate with Norethisterone Acetate

In respect of the tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28 and tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28:

 

 

In respect of the transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8 and transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8:

 

For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens

Oestradiol Valerate

Oestriol

Oestrogens—Conjugated

Oestrogens—Conjugated with Medroxyprogesterone Acetate

Ofloxacin

In compliance with authority procedures set out in subparagraph 14 (d):

Bacterial keratitis

Olanzapine

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

Maintenance treatment of bipolar I disorder

Olsalazine 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

Omeprazole

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

Zollinger-Ellison syndrome

Omeprazole and Clarithromycin and Amoxycillin Trihydrate

Eradication of Helicobacter pylori associated with peptic ulcer disease

Omeprazole Magnesium

In respect of the tablet equivalent to 20 mg omeprazole:

 

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

Zollinger-Ellison syndrome

 

In respect of the tablet equivalent to 10 mg omeprazole:

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

Zollinger-Ellison syndrome

Ondansetron

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with radiotherapy being used to treat malignancy

Ondansetron Hydrochloride Dihydrate

In respect of the tablet equivalent to 4 mg ondansetron, tablet equivalent to 8 mg ondansetron, I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule and I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule:

 

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy

 

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with radiotherapy being used to treat malignancy

 

In respect of the syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with radiotherapy being used to treat malignancy

Oxaliplatin

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil sodium and calcium folinate

Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil sodium and calcium folinate, following complete resection of the primary tumour

Oxazepam

Oxcarbazepine

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of partial epileptic seizures and primary generalised tonic-clonic seizures, which are not controlled satisfactorily by other anti-epileptic drugs

Oxprenolol Hydrochloride

Oxybutynin Hydrochloride

Detrusor overactivity where propantheline bromide has failed

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

Paclitaxel

In compliance with authority procedures set out in subparagraph 14 (d):

Adjuvant treatment of node-positive breast cancer administered sequentially to 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

 

Primary treatment of ovarian cancer in combination with a platinum compound

 

Locally advanced or metastatic non-small cell lung cancer

 

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Pancreatic Extract

Pancrelipase

Pantoprazole Sodium Sesquihydrate

In respect of the tablet (enteric coated), equivalent to 40 mg pantoprazole:

 

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

Zollinger-Ellison syndrome

 

In respect of the tablet (enteric coated), equivalent to 20 mg pantoprazole:

 

Gastro-oesophageal reflux disease

Paracetamol

In respect of the tablet 500 mg, oral liquid 120 mg per 5 mL, 100 mL and oral liquid 240 mg per 5 mL, 200 mL:

 

 

In respect of the tablet 665 mg (modified release):

 

Relief of persistent pain associated with osteoarthritis

Paraffin - Soft White with Paraffin - Liquid

Paroxetine Hydrochloride

Major depressive disorders

Obsessive-compulsive disorder

Panic disorder

Pemetrexed Disodium Heptahydrate

In compliance with authority procedures set out in subparagraph 14 (d):

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy

 

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated

 

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed

 

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful

 

Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences

Penicillamine

"Pepti-Junior"

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

 

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

Pergolide Mesylate

Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations

Perhexiline Maleate

In compliance with authority procedures set out in subparagraph 14 (d):

Angina not responding to other therapy

Pericyazine

Perindopril Arginine

Perindopril Arginine with Indapamide Hemihydrate

Hypertension in patients who are not adequately controlled with either indapamide hemihydrate or perindopril monotherapy

Perindopril Erbumine

Perindopril Erbumine with Indapamide Hemihydrate

Hypertension in patients who are not adequately controlled with either indapamide hemihydrate or perindopril monotherapy

Permethrin

Phenelzine Sulfate

Depression where all other anti-depressant therapy has failed or is inappropriate

"Phenex-1"

Phenylketonuria

"Phenex-2"

Phenylketonuria

Phenobarbitone

Epilepsy

Phenobarbitone Sodium

Epilepsy

Phenoxybenzamine Hydrochloride

Phaeochromocytoma

Neurogenic urinary retention

Phenoxymethylpenicillin Benzathine

Phenoxymethylpenicillin Potassium

Phenytoin

Phenytoin Sodium

"Phlexy-10"

Phenylketonuria

"Phlexy-10 Drink Mix"

Phenylketonuria

Pilocarpine Hydrochloride

Pimecrolimus

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of facial or eyelid atopic dermatitis in patients aged at least 3 months who have 1 or more of the following contraindications to topical corticosteroids:

 

 perioral dermatitis;

 

 periorbital dermatitis;

 

 rosacea;

 

 epidermal atrophy;

 

 dermal atrophy;

 

 allergy to topical corticosteroids;

 

 cataracts;

 

 glaucoma;

 

 raised intraocular pressure; and

 

 where 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 this purpose

 

Short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged at least 3 months who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy and where more than 3 months have passed since the initial diagnosis of atopic dermatitis; and

 

 where failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:

 

 failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or

 

 failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or

 

 clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or

 

 clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; and

 

 where 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 this purpose

Pindolol

Pioglitazone Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Initiation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients in whom a combination of metformin hydrochloride and a sulfonylurea is contraindicated or not tolerated, and:

 

 (a) who have glycosylated haemoglobin (HbA1c) greater than 7%; or

 

 (b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests; and

 

 where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application

 

Continuation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate

 

Initiation of therapy, in combination with insulin, in type 2 diabetes mellitus patients who, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin hydrochloride is contraindicated, have either:

 

 (a) glycosylated haemoglobin (HbA1c) greater than 7%; or

 

 (b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolyic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months, blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period; and

 

 where the date of the HbA1c measurement or the most recent blood glucose level, whichever is applicable in the circumstance, is included in the authority application and is no greater than 4 months old at the time of application

 

Continuation of therapy, in combination with insulin, in type 2 diabetes mellitus patients where the patient has previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate

Piperazine Oestrone Sulfate

Piroxicam

Chronic arthropathies (including osteoarthritis) with an inflammatory component

Pizotifen Malate

"PK AID II"

Phenylketonuria

"PKU-Express"

Phenylketonuria

"PKU Express Liquid"

Phenylketonuria

"PKU-gel"

Phenylketonuria

Pneumococcal Vaccine - Polyvalent

Splenectomised persons over 2 years of age

Persons with Hodgkin's disease

Persons at high risk of pneumococcal infections

Polyethylene Glycol 400 with Propylene Glycol

Severe dry eye syndrome, including Sjogren's syndrome

Polygeline

Polyvinyl Alcohol

Severe dry eye syndrome, including Sjogren's syndrome

Potassium Chloride

Potassium Chloride with Potassium Bicarbonate

Pravastatin Sodium

For use in accordance with paragraph 16

Prazosin Hydrochloride

Prednisolone

Prednisolone Acetate with Phenylephrine Hydrochloride

Corneal grafts

Uveitis

Prednisolone Sodium Phosphate

In respect of the oral solution equivalent to 5 mg prednisolone per mL, 30 mL and enema, retention, equivalent to 20 mg prednisolone in 100 mL:

 

 

In respect of the suppositories equivalent to 5 mg prednisolone, 10:

 

Proctitis

 

Ulcerative colitis

Prednisone

Primidone

Probenecid

Procaine Penicillin

Prochlorperazine

Prochlorperazine Maleate

Prochlorperazine Mesylate

Promethazine Hydrochloride

Propantheline Bromide

Detrusor overactivity

"Pro-Phree"

Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae

Propranolol Hydrochloride

Propylthiouracil

Pyrantel Embonate

Pyridostigmine Bromide

Pyrimethamine

Quetiapine Fumarate

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

Quinagolide Hydrochloride

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

Quinapril Hydrochloride

Quinapril Hydrochloride with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or quinapril hydrochloride monotherapy

Quinine Bisulfate

In compliance with authority procedures set out in subparagraph 14 (d):

Malaria

Quinine Sulfate

In compliance with authority procedures set out in subparagraph 14 (d):

Malaria

Rabeprazole Sodium

In respect of the tablet 20 mg (enteric coated):

 

Initial treatment of peptic ulcer

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

 

 

In respect of the tablet 10 mg (enteric coated):

 

Gastro-oesophageal reflux disease

 

Scleroderma oesophagus

Raloxifene Hydrochloride

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal 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 post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug

Raltitrexed

In compliance with authority procedures set out in subparagraph 14 (d):

For use as a single agent in the treatment of advanced colorectal cancer

Ramipril

Ranitidine Hydrochloride

"RCF"

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

Reboxetine Mesilate

Major depressive disorders

Reteplase

Treatment of acute myocardial infarction within 6 hours of onset of attack

Rifampicin

In respect of the capsule 150 mg and capsule 300 mg:

 

Prophylaxis of meningococcal disease in close contacts and carriers

 

Prophylactic treatment of contacts of patients with Haemophilus influenzae type B

 

In compliance with authority procedures set out in subparagraph 14 (d):

Leprosy in adults

 

In respect of the syrup 100 mg per 5 mL, 60 mL:

 

Prophylaxis of meningococcal disease in close contacts and carriers

 

Prophylactic treatment of contacts of patients with Haemophilus influenzae type B

Riluzole

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of amyotrophic lateral sclerosis, as diagnosed by a neurologist, in patients with disease duration of 2 years or less who have at least 60 percent of predicted forced vital capacity within 2 months prior to commencing riluzole therapy, and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow, and where the date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application

 

Continuing treatment of amyotrophic lateral sclerosis in patients who have previously been issued with an authority prescription for this drug and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow

Risedronate Sodium

In respect of the tablet 5 mg and tablet 35 mg:

 

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

 

In respect of the tablet 30 mg:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Symptomatic Paget's disease of bone

Risedronate Sodium 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

Risperidone

In respect of the tablet 0.5 mg and tablet 0.5 mg (orally disintegrating):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful

 

Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in a child or adolescent aged less than 18 years with autism, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) international classification of mental and behavioural disorders

 

Schizophrenia

 

In respect of the tablet 1 mg and tablet 1 mg (orally disintegrating):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful

 

Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in a child or adolescent aged less than 18 years with autism, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) international classification of mental and behavioural disorders

 

Schizophrenia

 

Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder

 

In respect of the tablet 2 mg and tablet 2 mg (orally disintegrating):

 

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in a child or adolescent aged less than 18 years with autism, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) international classification of mental and behavioural disorders

 

Schizophrenia

 

Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder

 

In respect of the tablet 3 mg, tablet 3 mg (orally disintegrating), tablet 4 mg, tablet 4 mg (orally disintegrating) and oral solution 1 mg per mL, 100 mL:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

 

Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder

 

In respect of the oral solution 1 mg per mL, 30 mL:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful

 

Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in a child or adolescent aged less than 18 years with autism, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) international classification of mental and behavioural disorders

 

In respect of the I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL, I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL and I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL:

 

In compliance with authority procedures set out in subparagraph 14 (d):

Schizophrenia

Rituximab

In compliance with authority procedures set out in subparagraph 14 (d):

Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma

 

Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma

 

Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy

 

Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy

Rivastigmine Hydrogen Tartrate

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

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