National Health Act 1953 Declaration under subsections 85(2) and 85(2AA) Determinations under subsection 85(2A) drugs and medicinal preparations (No. PB 113 of 2008) (Cth)

Declaration and Determination — Drugs and medicinal preparations
(PB 113 of 2008)

as amended

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

National Health Act 1953

This compilation was prepared on 1 March 2010
taking into account amendments up to PB 4 of 2010

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

Declaration and determination — Drugs and medicinal preparations
(PB 113 of 2008)

Commencement [see Note 1]

1. This instrument commences on 1 December 2008.

Repeal

2. Instrument number PB 74 of 2008 is repealed.

Definitions

3. In this instrument:

“Act” means the National Health Act 1953;

“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;

“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;

“GP Management Plan” means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need;

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

“PBS” means Pharmaceutical Benefits Scheme;

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

“ready-prepared pharmaceutical benefit” means a pharmaceutical item in respect of which there is in force a determination under subsection 85(6) of the Act;

“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960;

“Team Care Arrangements” means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient.

Drugs and medicinal preparations to which Part VII applies

4. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner.

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

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

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

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

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

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

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

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

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

Circumstances

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

13. Where circumstances are specified in column 2 of Schedule 4 for a drug or medicinal preparation specified in column 1 of that Schedule, an extemporaneously prepared pharmaceutical benefit that contains the drug or medicinal preparation as an ingredient is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

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

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

(b) where a disease or condition is specified in column 3 of Schedule 1 or column 2 of Schedule 1A, 2, 2A or 4 —

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(ii) in any other case:

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

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

(b) if the prescription was submitted in accordance with subsubparagraph 14(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or

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

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

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

(b) the medical practitioner or authorised optometrist must:

(i) mark that number on the prescription; and

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

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

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

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

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

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

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

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

(i) coronary heart disease which has become symptomatic;

(ii) cerebrovascular disease which has become symptomatic;

(iii) peripheral vascular disease which has become symptomatic;

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

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

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

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

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

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

Category of patient Fasting lipid level

Patients with diabetes mellitus not otherwise included total cholesterol greater than 5.5 mmol per L

Aboriginal or Torres Strait Islander patients;

Patients with hypertension

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients with high density lipoprotein cholesterol less than 1 mmol per L total cholesterol greater than 6.5 mmol per L

Patients with familial hypercholesterolaemia identified by:

(1) DNA mutation; or

(2) tendon xanthomas in the patient or their first or second degree relative

Patients with:

(1) family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or

(2) family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives

If aged 18 years or less at treatment initiation:

low density lipoprotein cholesterol greater than 4 mmol per L

If aged more than 18 years at treatment initiation:

low density lipoprotein cholesterol greater than 5 mmol per L;

or

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients not eligible under the above:

(1) men over 34 but less than 76 years of age; or

(2) post-menopausal women less than 76 years of age

total cholesterol greater than 7.5 mmol per L;

or

triglyceride greater than 4 mmol per L

Patients not otherwise included
total cholesterol greater than 9 mmol per L;

or

triglyceride greater than 8 mmol per L

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

SCHEDULE 1 – READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A MEDICAL PRACTITIONER
Column 1 Listed Drug	Column 2 Streamlined authority code	Column 3 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Abciximab	In compliance with authority procedures set out in subparagraph 14 (d):
1716	Patients undergoing percutaneous coronary balloon angioplasty
1717	Patients undergoing percutaneous coronary atherectomy
1718	Patients undergoing percutaneous coronary stent placement
Acamprosate	In compliance with authority procedures set out in subparagraph 14 (d):
2665	For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence
Acarbose	—
Acetazolamide	—
Acetylcysteine	Bronchiectasis
Cystic fibrosis
Aciclovir	In respect of the tablet 200 mg: In compliance with authority procedures set out in subparagraph 14 (d):
Moderate to severe initial genital herpes
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
In respect of the tablet 800 mg: In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Herpes zoster ophthalmicus
Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)
In respect of the eye ointment 30 mg per g, 4.5 g: Herpes simplex keratitis
Acitretin	In compliance with authority procedures set out in subparagraph 14 (d):
1366	Severe intractable psoriasis
1363	Severe forms of disorders of keratinisation
Adalimumab	In respect of the injection 40 mg in 0.8 mL pre-filled syringe, 6 and injection 40 mg in 0.8 mL pre-filled pen, 6:
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:

SCHEDULE 1 – READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A MEDICAL PRACTITIONER — continued
Column 1 Listed Drug	Column 2 Streamlined authority code	Column 3 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (d) 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 mentioned 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;
failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the most recent CDAI assessment is no more than 1 month old at the time of application;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(iii) the signed patient acknowledgement;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
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 gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and
(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab 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 (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment 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;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and
(c) has evidence of intestinal inflammation; and
(d) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(e) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(f) has failed to achieve an adequate response to prior systemic drug therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (f) 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 mentioned at (f) 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;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have evidence of intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, 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/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(b) be assessed clinically as being in a high faecal output state; and/or
(c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has short gut syndrome or an ileostomy or colostomy and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
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 gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criteria, if relevant; and (ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment;
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab 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 (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and
(c) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(d) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(e) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (e) 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 mentioned at (e) 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;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and/or
(b) have evidence of active intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, 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/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(c) be assessed clinically as being in a high faecal output state; and/or
(d) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) (1) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; or
(2) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the dates of assessment of the patient's condition, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
In respect of the injection 40 mg in 0.8 mL pre-filled syringe and injection 40 mg in 0.8 mL pre-filled pen:
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (d) 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 mentioned 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;
failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the most recent CDAI assessment is no more than 1 month old at the time of application;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(iii) the signed patient acknowledgement;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
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 gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and
(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab 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 (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment 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;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and
(c) has evidence of intestinal inflammation; and
(d) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(e) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(f) has failed to achieve an adequate response to prior systemic drug therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (f) 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 mentioned at (f) 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;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have evidence of intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, 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/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(b) be assessed clinically as being in a high faecal output state; and/or
(c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has short gut syndrome or an ileostomy or colostomy and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
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 gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criteria, if relevant; and (ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment;
to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab 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 (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and
(c) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and
(d) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(e) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (e) 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 mentioned at (e) 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;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and/or
(b) have evidence of active intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, 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/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(c) be assessed clinically as being in a high faecal output state; and/or
(d) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) (1) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; or
(2) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the dates of assessment of the patient's condition, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 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 gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Crohn disease
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 gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and
(ii) the signed patient acknowledgment;
the current CDAI assessment is no more than 1 month old at the time of application;
the baseline CDAI assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS-subsidised treatment under this restriction once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition;
the CDAI assessment is no more than 1 month old at the time of application;
the CDAI assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(b) reversal of high faecal output state; or
(c) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment;
the patient's assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, or consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

(a) has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or
(iii) the date of clinical assessment;
all assessments are no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Medicare Australia CEO as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS-subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Crohn disease
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal (or general) medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or
(2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab according to the criteria included in the relevant continuation restriction; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction;
the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient's condition; or
(2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or
(3) the date of clinical assessment(s); and
(ii) the signed patient acknowledgement;
the patient's assessment is no more than 1 month old at the time of application;
the baseline assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS-subsidised treatment under this restriction once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Rheumatoid arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 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
Rheumatoid arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and
(c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised adalimumab therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Rheumatoid arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
(b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Psoriatic arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and
(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Psoriatic arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
(3) have not failed treatment with adalimumab during the current Treatment Cycle; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Psoriatic arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) were receiving treatment with adalimumab prior to 16 March 2006; and
(3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;
the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Psoriatic arthritis
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
where biological agent means adalimumab or etanercept or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Ankylosing spondylitis
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
Ankylosing spondylitis
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
Ankylosing spondylitis
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
Ankylosing spondylitis
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
Chronic plaque psoriasis (whole body) — initial treatment 1
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Chronic plaque psoriasis (whole body) — initial treatment 2
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS-subsidised therapy with adalimumab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients who have previously demonstrated a response to PBS-subsidised treatment with adalimumab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS-subsidised adalimumab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Chronic plaque psoriasis (whole body) — initial treatment 3
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 as systemic monotherapy (other than methotrexate) 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 adalimumab prior to 1 March 2009; and
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with adalimumab; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the whole body; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of adalimumab therapy) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
the most recent PASI assessment is no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and were receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2009, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (whole body) — continuing treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with adalimumab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with adalimumab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient’s response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with adalimumab;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has received prior PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more, starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuation of initial treatment as systemic monotherapy (other than methotrexate), in a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

SCHEDULE 2 – READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A PARTICIPATING DENTAL PRACTITIONER
Column 1 Listed Drug	Column 2 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Adrenaline	—
Amoxycillin	—
Amoxycillin with Clavulanic Acid	Infections where resistance to amoxycillin trihydrate is suspected
Infections where resistance to amoxycillin trihydrate is proven
Amphotericin	—
Ampicillin	—
Aspirin	—
Atropine	—
Benzathine benzylpenicillin	—
Benztropine	—
Benzydamine	Radiation induced mucositis
Benzylpenicillin	—
Betamethasone	For local intra-articular or peri-articular infiltration
Keloid
Lichen planus hypertrophic
Carbamazepine	—
Cefaclor	—
Cefalotin	—
Cefotaxime	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Cefuroxime	—
Cephalexin	—
Chloramphenicol	—
Clindamycin	Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin
Codeine	—
Codeine with Paracetamol	—
Diazepam	—
Diclofenac	In respect of the tablet (enteric coated) containing diclofenac sodium 25 mg and tablet (enteric coated) containing diclofenac sodium 50 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository containing diclofenac sodium 100 mg: —
Dicloxacillin	Serious staphylococcal infections
Doxycycline	—
Erythromycin	—
Flucloxacillin	In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL: Serious staphylococcal infections
In respect of the powder for injection 500 mg (as sodium) and powder for injection 1 g (as sodium): —
Glucagon	—
Glucose	—
Glyceryl Trinitrate	—
Hydrocortisone	In respect of the injection 100 mg (as sodium succinate) with 2 mL solvent and injection 250 mg (as sodium succinate) with 2 mL solvent: For use in a hospital
In respect of the cream containing hydrocortisone acetate 10 mg per g, 30 g, cream containing hydrocortisone acetate 10 mg per g, 50 g, ointment containing hydrocortisone acetate 10 mg per g, 30 g and ointment containing hydrocortisone acetate 10 mg per g, 50 g: Treatment of corticosteroid-responsive dermatoses

SCHEDULE 2 – READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A PARTICIPATING DENTAL PRACTITIONER — continued
Column 1 Listed Drug	Column 2 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Hydromorphone	In respect of the tablet containing hydromorphone hydrochloride 2 mg, tablet containing hydromorphone hydrochloride 4 mg, tablet containing hydromorphone hydrochloride 8 mg and oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL: Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet (modified release) containing hydromorphone hydrochloride 4 mg, tablet (modified release) containing hydromorphone hydrochloride 8 mg, tablet (modified release) containing hydromorphone hydrochloride 16 mg, tablet (modified release) containing hydromorphone hydrochloride 32 mg and tablet (modified release) containing hydromorphone hydrochloride 64 mg: Chronic severe disabling pain not responding to non-narcotic analgesics
In respect of the injection containing hydromorphone hydrochloride 2 mg in 1 mL, injection containing hydromorphone hydrochloride 10 mg in 1 mL and injection containing hydromorphone hydrochloride 50 mg in 5 mL: —
Ibuprofen	In respect of the tablet 200 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the tablet 400 mg: —
Indomethacin	In respect of the capsule 25 mg: Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
In respect of the suppository 100 mg: —
Ketoprofen	In respect of the capsule 200 mg (sustained release): Chronic arthropathies (including osteoarthritis) with an inflammatory component
In respect of the suppository 100 mg: —
Lignocaine	—
Lincomycin	—
Methylprednisolone	For local intra-articular or peri-articular infiltration
Metoclopramide	—
Metronidazole	In respect of the tablet 200 mg, tablet 400 mg, oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL and suppositories 500 mg, 10: —
In respect of the I.V. infusion 500 mg in 100 mL: Treatment, in a hospital, of acute anaerobic sepsis
Morphine	In respect of the tablet containing morphine sulfate 30 mg, oral solution containing morphine hydrochloride 2 mg per mL, 200 mL, oral solution containing morphine hydrochloride 5 mg per mL, 200 mL and oral solution containing morphine hydrochloride 10 mg per mL, 200 mL: Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet containing morphine sulfate 5 mg (controlled release), tablet containing morphine sulfate 10 mg (controlled release), tablet containing morphine sulfate 15 mg (controlled release), tablet containing morphine sulfate 30 mg (controlled release), tablet containing morphine sulfate 60 mg (controlled release), tablet containing morphine sulfate 100 mg (controlled release), capsule containing morphine sulfate 10 mg (containing sustained release pellets), capsule containing morphine sulfate 20 mg (containing sustained release pellets), capsule containing morphine sulfate 30 mg (controlled release), capsule containing morphine sulfate 50 mg (containing sustained release pellets), capsule containing morphine sulfate 60 mg (controlled release), capsule containing morphine sulfate 90 mg (controlled release), capsule containing morphine sulfate 100 mg (containing sustained release pellets), capsule containing morphine sulfate 120 mg (controlled release), sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet, sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet, sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet and sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet: Chronic severe disabling pain not responding to non-narcotic analgesics
In respect of the injection containing morphine sulfate 10 mg in 1 mL, injection containing morphine sulfate 15 mg in 1 mL and injection containing morphine sulfate 30 mg in 1 mL: —
Naloxone	—
Naproxen	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Nitrazepam	—
Nystatin	—
Oxazepam	—
Oxycodone	In respect of the tablet containing oxycodone hydrochloride 5 mg, capsule containing oxycodone hydrochloride 5 mg, capsule containing oxycodone hydrochloride 10 mg, capsule containing oxycodone hydrochloride 20 mg, oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL and suppository 30 mg (as pectinate): Severe disabling pain not responding to non-narcotic analgesics
In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 15 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 30 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics
Paracetamol	—
Phenoxymethylpenicillin	—
Piroxicam	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Procaine Penicillin	—
Prochlorperazine	—
Promethazine	—
Sodium Chloride	—
Sodium Chloride with Glucose	—
Sulindac	Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Temazepam	—
Ticarcillin with Clavulanic Acid	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Tramadol	In respect of the capsule containing tramadol hydrochloride 50 mg: For acute pain where aspirin or paracetamol alone is inappropriate or has failed
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg, tablet (sustained release) containing tramadol hydrochloride 200 mg, tablet (extended release) containing tramadol hydrochloride 200 mg, tablet (extended release) containing tramadol hydrochloride 300 mg and oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL: For pain where aspirin or paracetamol alone is inappropriate or has failed
In respect of the injection containing tramadol hydrochloride 100 mg in 2 mL: Short-term treatment of acute pain
Triamcinolone	For local intra-articular or peri-articular infiltration
Keloid
Lichen planus hypertrophic
Trimethoprim with Sulfamethoxazole	—
Vancomycin	Prophylaxis of endocarditis in patients hypersensitive to penicillin

SCHEDULE 2A – READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY AN AUTHORISED OPTOMETRIST
Column 1 Listed Drug	Column 2 Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Aciclovir		Herpes simplex keratitis
Betaxolol		―
Bimatoprost		―
Bimatoprost with timolol		Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies
Brimonidine		―
Brimonidine with Timolol		Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Brinzolamide		―
Carbomer		In respect of the eye gel 2 mg per g, 10 g: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye gel 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
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
Carmellose		In respect of the eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30, eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d):
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Carmellose with glycerin		Severe dry eye syndrome, including Sjogren’s syndrome
Chloramphenicol		—
Cromoglycic Acid		Vernal kerato-conjunctivitis
Dorzolamide		―
Dorzolamide with Timolol		Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL
Fluorometholone		—
Flurbiprofen		—
Framycetin		—
Hydrocortisone		—
Hypromellose		Severe dry eye syndrome, including Sjogren’s syndrome
Hypromellose with Carbomer 980		Severe dry eye syndrome, including Sjogren’s syndrome
Hypromellose with Dextran		In respect of the eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL: Severe dry eye syndrome, including Sjogren’s syndrome In respect of the eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28: In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eyes syndrome in patients who are sensitive to preservatives in multi-dose eye drops
Latanoprost		―
Latanoprost with Timolol		Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies
Paraffin		—
Pilocarpine		―
Polyethylene glycol 400		In respect of the eye drops 2.5 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 0.4 mL, 20: 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
Polyethylene Glycol 400 with Propylene Glycol		In respect of the eye drops 4 mg-3 mg per mL, 15 mL: Severe dry eye syndrome, including Sjogren’s syndrome
In respect of the eye drops 4 mg-3 mg per mL, single dose units 0.8 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
Polyvinyl Alcohol		Severe dry eye syndrome, including Sjogren’s syndrome
Soy lecithin		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
Sulfacetamide		—
Timolol		―
Travoprost		―
Travoprost with Timolol		Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

SCHEDULE 3 – ALLOWABLE COMPOUNDS OF READY-PREPARED DRUGS OR MEDICINAL PREPARATIONS
Column 1 Listed Drug	Column 2 Allowable compounds
Abacavir	Abacavir with Lamivudine Abacavir with Lamivudine and Zidovudine
Alendronic Acid	Alendronic Acid with Colecalciferol
Alginic Acid	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Aluminium Hydroxide	Aluminium Hydroxide with Magnesium Hydroxide
Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Amiloride	Hydrochlorothiazide with Amiloride
Amlodipine	Amlodipine with Atorvastatin
Amlodipine with Valsartan
Amoxycillin	Amoxycillin with Clavulanic Acid
Amoxycillin with Clavulanic Acid and Water – Purified BP
Amoxycillin with Water – Purified BP
Artemether	Artemether with Lumefantrine
Aspirin	Clopidogrel with Aspirin Dipyridamole with Aspirin
Atorvastatin	Amlodipine with Atorvastatin
Atovaquone	Atovaquone with proguanil
Atropine	Diphenoxylate with Atropine
Azithromycin	Azithromycin with Water – Purified BP
Bacitracin	Neomycin with Bacitracin
Benserazide	Levodopa with Benserazide
Betamethasone	Calcipotriol with Betamethasone
Bimatoprost	Bimatoprost with Timolol
Brimonidine	Brimonidine with Timolol
Budesonide	Budesonide with Eformoterol
Buprenorphine	Buprenorphine with Naloxone
Calcipotriol	Calcipotriol with Betamethasone
Calcium	Calcium with Colecalciferol
Calcium Carbonate	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Candesartan	Candesartan with Hydrochlorothiazide
Carbidopa	Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Carbomer 980	Hypromellose with Carbomer 980
Carmellose	Carmellose with Glycerin
Cefaclor	Cefaclor with Water – Purified BP
Cephalexin	Cephalexin with Water – Purified BP
Clarithromycin	Clarithromycin with Water – Purified BP
Clavulanic Acid	Amoxycillin with Clavulanic Acid Amoxycillin with Clavulanic Acid and Water – Purified BP Ticarcillin with Clavulanic Acid
Clopidogrel	Clopidogrel with Aspirin
Codeine	Codeine with Paracetamol
Colecalciferol	Alendronic Acid with Colecalciferol Calcium with Colecalciferol
Dexamethasone	Dexamethasone with Framycetin and Gramicidin
Dextran	Hypromellose with Dextran
Diphenoxylate	Diphenoxylate with Atropine
Dipyridamole	Dipyridamole with Aspirin
Dorzolamide	Dorzolamide with Timolol
Dydrogesterone	Oestradiol with Dydrogesterone
Efavirenz	Tenofovir with Emtricitabine and Efavirenz

SCHEDULE 3 – ALLOWABLE COMPOUNDS OF READY-PREPARED DRUGS OR MEDICINAL PREPARATIONS — continued
Column 1 Listed Drug	Column 2 Allowable compounds
Eformoterol	Budesonide with Eformoterol
Emtricitabine	Tenofovir with Emtricitabine Tenofovir with Emtricitabine and Efavirenz
Enalapril	Enalapril with Hydrochlorothiazide Lercanidipine with Enalapril
Entacapone	Levodopa with Carbidopa and Entacapone
Eprosartan	Eprosartan with Hydrochlorothiazide
Erythromycin	Erythromycin with Water – Purified BP
Ethinyloestradiol	Levonorgestrel with Ethinyloestradiol Norethisterone with Ethinyloestradiol
Ezetimibe	Ezetimibe with Simvastatin
Felodipine	Ramipril with Felodipine
Ferrous Fumarate	Ferrous Fumarate with Folic Acid
Flucloxacillin	Flucloxacillin with Water – Purified BP
Fluticasone	Fluticasone with Salmeterol
Folic Acid	Ferrous Fumarate with Folic Acid
Fosinopril	Fosinopril with Hydrochlorothiazide
Framycetin	Dexamethasone with Framycetin and Gramicidin
Frangula Bark	Sterculia with Frangula Bark
Glibenclamide	Metformin with Glibenclamide
Glucose	Sodium Chloride with Glucose
Glycerin	Carmellose with Glycerin
Gramicidin	Dexamethasone with Framycetin and Gramicidin Triamcinolone with Neomycin, Gramicidin and Nystatin
Hydrochlorothiazide	Candesartan with Hydrochlorothiazide
Enalapril with Hydrochlorothiazide
Eprosartan with Hydrochlorothiazide
Fosinopril with Hydrochlorothiazide
Hydrochlorothiazide with Amiloride
Hydrochlorothiazide with Triamterene
Irbesartan with Hydrochlorothiazide
Olmesartan with Hydrochlorothiazide
Quinapril with Hydrochlorothiazide
Telmisartan with Hydrochlorothiazide
Valsartan with Hydrochlorothiazide
Hypromellose	Hypromellose with Carbomer 980 Hypromellose with Dextran
Indapamide	Perindopril with Indapamide
Insulin Aspart	Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Aspart Protamine Suspension	Insulin Aspart with Insulin Aspart Protamine Suspension
Insulin Isophane	Insulin Neutral with Insulin Isophane
Insulin Lispro	Insulin Lispro with Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension	Insulin Lispro with Insulin Lispro Protamine Suspension
Insulin Neutral	Insulin Neutral with Insulin Isophane
Irbesartan	Irbesartan with Hydrochlorothiazide
Lamivudine	Abacavir with Lamivudine Abacavir with Lamivudine and Zidovudine Lamivudine with Zidovudine
Latanoprost	Latanoprost with Timolol
Lercanidipine	Lercanidipine with Enalapril
Levodopa	Levodopa with Benserazide Levodopa with Carbidopa Levodopa with Carbidopa and Entacapone
Levonorgestrel	Levonorgestrel with Ethinyloestradiol
Lopinavir	Lopinavir with Ritonavir
Lumefantrine	Artemether with Lumefantrine
Magnesium Hydroxide	Aluminium Hydroxide with Magnesium Hydroxide Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Magnesium Trisilicate	Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Mestranol	Norethisterone with Mestranol
Metformin	Metformin with Glibenclamide Rosiglitazone with Metformin
Sitagliptin with Metformin
Mycophenolic Acid	Mycophenolic Acid with Water – Purified BP
Naloxone	Buprenorphine with Naloxone
Neomycin	Neomycin with Bacitracin Triamcinolone with Neomycin, Gramicidin and Nystatin
Norethisterone	Norethisterone with Ethinyloestradiol Norethisterone with Mestranol Oestradiol with Norethisterone
Nystatin	Triamcinolone with Neomycin, Gramicidin and Nystatin
Oestradiol	Oestradiol with Dydrogesterone Oestradiol with Norethisterone
Olmesartan	Olmesartan with Hydrochlorothiazide
Paracetamol	Codeine with Paracetamol
Perindopril	Perindopril with Indapamide
Phenylephrine	Prednisolone with Phenylephrine
Polyethylene Glycol 400	Polyethylene Glycol 400 with Propylene Glycol
Potassium Bicarbonate	Potassium Chloride with Potassium Bicarbonate
Potassium Chloride	Potassium Chloride with Potassium Bicarbonate
Prednisolone	Prednisolone with Phenylephrine
Proguanil	Atovaquone with proguanil
Propylene Glycol	Polyethylene Glycol 400 with Propylene Glycol
Quinapril	Quinapril with Hydrochlorothiazide
Ramipril	Ramipril with Felodipine
Ritonavir	Lopinavir with Ritonavir
Rosiglitazone	Rosiglitazone with Metformin
Salmeterol	Fluticasone with Salmeterol
Simvastatin	Ezetimibe with Simvastatin
Sitagliptin	Sitagliptin with Metformin
Sodium Bicarbonate	Alginic Acid with Calcium Carbonate and Sodium Bicarbonate
Sodium Chloride	Sodium Chloride with Glucose
Sodium Citrate	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sodium Lauryl Sulfoacetate	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Sorbitol	Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Stavudine	Stavudine with Water – Purified BP
Sterculia	Sterculia with Frangula Bark
Sulfamethoxazole	Trimethoprim with Sulfamethoxazole
Telmisartan	Telmisartan with Hydrochlorothiazide
Tenofovir	Tenofovir with Emtricitabine Tenofovir with Emtricitabine and Efavirenz
Ticarcillin	Ticarcillin with Clavulanic Acid
Timolol	Bimatoprost with Timolol
Brimonidine with Timolol
Dorzolamide with Timolol
Latanoprost with Timolol
Travoprost with Timolol
Trandolapril	Trandolapril with Verapamil
Travoprost	Travoprost with Timolol
Triamcinolone	Triamcinolone with Neomycin, Gramicidin and Nystatin
Triamterene	Hydrochlorothiazide with Triamterene
Trimethoprim	Trimethoprim with Sulfamethoxazole
Valsartan	Amlodipine with Valsartan
Valsartan with Hydrochlorothiazide
Verapamil	Trandolapril with Verapamil
Voriconazole	Voriconazole with Water —Purified BP
Water – Purified BP	Amoxycillin with Clavulanic Acid and Water – Purified BP
Amoxycillin with Water – Purified BP
Azithromycin with Water – Purified BP
Cefaclor with Water – Purified BP
Cephalexin with Water – Purified BP
Clarithromycin with Water – Purified BP
Erythromycin with Water – Purified BP
Flucloxacillin with Water – Purified BP
Mycophenolic Acid with Water – Purified BP
Stavudine with Water – Purified BP
Voriconazole with Water —Purified BP
Zidovudine	Abacavir with Lamivudine and Zidovudine Lamivudine with Zidovudine

SCHEDULE 4 – DRUGS OR MEDICINAL PREPARATIONS THAT MAY BE USED AS INGREDIENTS OF EXTEMPORANEOUSLY-PREPARED PHARMACEUTICAL BENEFITS
Column 1	Column 2
Name of pharmaceutical benefit	Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Acacia BP, powdered	—
Acetic Acid (33 per cent) BP	—
Alum BP	—
Aluminium Acetate Solution BP	—
Aqueous Cream APF	For use only as a base combined with active ingredients
Ascorbic Acid BP	For use only as an ingredient of ferrous sulfate mixtures
Aspirin BP	—
Belladonna Tincture BP	—
Benzocaine BP	—
Benzoic Acid BP	—
Benzoin Tincture Compound BP	—
Boric Acid, Olive Oil and Zinc Oxide Ointment QHF	—
Calcium Hydroxide BP	—
Cetomacrogol Cream, Aqueous APF	For use only as a base combined with active ingredients
Cetrimide Cream, Aqueous APF	For use only as a base combined with active ingredients
Chlorhexidine Cream, Aqueous APF	For use only as a base combined with active ingredients
Citric Acid Monohydrate BP	—
Coal Tar BP	—
Coal Tar Solution BP	—
Cocaine Hydrochloride BP	—
Coconut Oil BP	—
Codeine Phosphate BP	May only be prescribed in linctuses, mixtures and mixtures for children
Collodion Flexible BP	—
Dithranol BP	—
Emulsifying Ointment BP	For use only as a base combined with active ingredients
Ephedrine Hydrochloride BP	May only be prescribed in nasal instillations
Ferrous Sulfate BP	—
Formaldehyde Solution BP	—
Gentian Alkaline Mixture APF	—
Glycerol BP	—
Iodine BP	—
Kaolin Mixture BPC 1968	—
Kaolin and Opium Mixture APF 14	—
Lactic Acid BP	—
Lavender Oil, Spike BPC 1968	—
Levomenthol BP	—
Liquorice Liquid Extract BP	—
Magnesium Carbonate, Light BP	—
Magnesium Sulfate BP	May only be prescribed for other than oral use
Magnesium Trisilicate BP	—
Menthol, Racemic BP	—
Methyl Hydroxybenzoate BP	—
Paraffin, Hard BP	—
Paraffin, Light Liquid BP	—
Paraffin, Liquid BP	May only be prescribed for other than oral use
Paraffin, Soft White BP	—
Paraffin, Soft Yellow BP	—
Phenobarbitone Sodium BP	May only be prescribed for the treatment of epilepsy
Phenol, Liquefied BP	Not available for ear drops
Podophyllum Resin BP	—

SCHEDULE 4 – DRUGS OR MEDICINAL PREPARATIONS THAT MAY BE USED AS INGREDIENTS OF EXTEMPORANEOUSLY-PREPARED PHARMACEUTICAL BENEFITS — continued
Column 1	Column 2
Name of pharmaceutical benefit	Circumstances (if any) specified for the purposes of section 85(2A)(b) of the Act
Potassium Citrate BP	—
Potassium Iodide BP	—
Potassium Permanganate BP	—
Propyl Hydroxybenzoate BP	—
Propylene Glycol BP	—
Red Syrup APF 15	—
Resorcinol BP	—
Salicylic Acid BP	—
Simple Ointment (white) BP	For use only as a base combined with active ingredients
Simple Ointment (yellow) BP	For use only as a base combined with active ingredients
Sodium Bicarbonate BP	—
Sodium Chloride BP	—
Sodium Citrate BP	—
Starches BP	—
Sulfur, Precipitated BP 1980	—
Syrup BP	—
Talc, Purified BP, sterilised	—
Thymol BP	—
Thymol Mouth Wash, Compound APF 15	—
Tragacanth BP, powdered	—
Tragacanth Powder, Compound BP 1980	—
Trichloroacetic Acid BP 1980	—
Triethanolamine BP	—
Water For Injections, sterilised BP	May only be prescribed in eye drops and eye lotions
Water, Purified BP	—
Wool Alcohols Ointment (white) BP	For use only as a base combined with active ingredients
Wool Alcohols Ointment (yellow) BP	For use only as a base combined with active ingredients
Wool Fat BP	—
Wool Fat, Hydrous BP	—
Zinc Cream BP	For use only as a base combined with active ingredients
Zinc Oxide BP	—
Zinc Sulfate BP	—

SCHEDULE 5 – ADDITIVES

Acetone BP

Anise Water, Concentrated BP

Boric Acid BP

Castor Oil BP

Chlorhexidine Acetate BP

Chloroform BP

Ethanol (96 per cent) BP

Ethanols, Dilute BP

Ether, Solvent BP

Eucalyptus Oil BP

Honey, Purified BP 1993

Industrial Methylated Spirit BP

Olive Oil BP

Peppermint Oil BP

Peppermint Water, Concentrated APF

Sodium Thiosulfate BP

SCHEDULE 6 – ADDITIONAL PHARMACEUTICAL BENEFITS MADE AVAILABLE UNDER ARRANGEMENTS PROVIDED FOR BY SECTION 100 OF THE ACT
Abacavir
Abacavir with Lamivudine
Abacavir with Lamivudine and Zidovudine
Abatacept
Adefovir
Ambrisentan
Apomorphine
Atazanavir
Bosentan
Botulinum Toxin Type A Purified Neurotoxin Complex
Buprenorphine
Buprenorphine with Naloxone
Choriogonadotropin alfa
Cidofovir
Clostridium Botulinum Type A Toxin—Haemagglutinin Complex
Clozapine
Darbepoetin Alfa
Darunavir
Deferasirox
Deferiprone
Delavirdine
Desferrioxamine
Didanosine
Dornase Alfa
Efavirenz
Emtricitabine
Enfuvirtide
Entecavir
Epoetin Alfa
Epoetin Beta
Epoprostenol
Etravirine
Filgrastim
Fosamprenavir
Foscarnet
Ganciclovir
Iloprost
Indinavir
Infliximab
Interferon Gamma-1b
Lamivudine
Lamivudine with Zidovudine
Lanreotide
Lenalidomide
Lenograstim
Lopinavir with Ritonavir
Natalizumab
Nevirapine
Octreotide
Pegfilgrastim
Peginterferon Alfa-2a
Peginterferon Alfa-2b
Progesterone
Raltegravir

SCHEDULE 6 – ADDITIONAL PHARMACEUTICAL BENEFITS MADE AVAILABLE UNDER ARRANGEMENTS PROVIDED FOR BY SECTION 100 OF THE ACT — continued

Ribavirin and Peginterferon Alfa-2a

Ribavirin and Peginterferon Alfa-2b

Rifabutin

Ritonavir

Saquinavir

Sildenafil

Sitaxentan

Somatropin

Stavudine

Telbivudine

Tenofovir

Tenofovir with Emtricitabine

Tenofovir with Emtricitabine and Efavirenz

Thalidomide

Tipranavir

Trastuzumab

Valganciclovir

Zidovudine

Notes to the Declaration and Determination — Drugs and medicinal preparations (PB 113 of 2008)

Note 1

The Declaration and Determination — Drugs and medicinal preparations (PB 113 of 2008) (in force under subsections 85(2), 85(2AA) and 85(2A) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of FRLI Registration	Date of commencement	Application, saving or transitional provisions
PB 113 of 2008	27 Nov 2008 (see F2008L04383)	1 Dec 2008
PB 124 of 2008	11 Dec 2008 (see F2008L04633)	1 Jan 2009	—
PB 1 of 2009	14 Jan 2009 (see F2009L00027)	1 Feb 2009	—
PB 8 of 2009	11 Feb 2009 (see F2009L00420)	1 Mar 2009	—
PB 20 of 2009	18 Mar 2009 (see F2009L01071)	1 Apr 2009	—
PB 31 of 2009	8 Apr 2009 (see F2009L01248)	1 May 2009	—
PB 39 of 2009	11 May 2009 (see F2009L01713)	1 June 2009	—
PB 47 of 2009	12 June 2009 (see F2009L02287)	1 July 2009	—
PB 62 of 2009	10 July 2009 (see F2009L02705)	1 Aug 2009	—
PB 75 of 2009	17 Aug 2009 (see F2009L03148)	1 Sept 2009	—
PB 86 of 2009	17 Sept 2009 (see F2009L03544)	1 Oct 2009	—
PB 96 of 2009	13 Oct 2009 (see F2009L03829)	1 Nov 2009	—
PB 106 of 2009	20 Nov 2009 (see F2009L04287)	1 Dec 2009	—
PB 118 of 2009	9 Dec 2009 (see F2009L04558)	1 Jan 2010	—
PB 128 of 2009	13 Jan 2010 (see F2010L00099)	1 Feb 2010	—
PB 4 of 2010	17 Feb 2010 (see F2010L00471)	1 Mar 2010	—

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected		How affected
Schedule 1
Schedule 1......................................		am. PB 124 of 2008; PB 1, 8, 20, 31, 39, 47, 62, 75, 86, 96, 106, 118 and 128 of 2009; PB 4 of 2010
Schedule 1A
Schedule 1A...................................		am. PB 62 of 2009; PB 4 of 2010
Schedule 2
Schedule 2......................................		am. PB 20, 31 and 128 of 2009
Schedule 2A
Schedule 2A...................................		am. PB 8, 20, 39, 47, 62 and 106 of 2009
Schedule 3
Schedule 3......................................		am. PB 8, 39, 47, 62, 106, 118 and 128 of 2009
Schedule 6
Schedule 6......................................		am. PB 124 of 2008; PB 47, 96, 106 and 118 of 2009