National Health Act 1953 Declaration under subsections 85(2) and 85(2AA) Determination under subsection 85(2A) drugs and medicinal preparations (No. PB 14 of 2010) (Cth)

Declaration and Determination — Drugs and medicinal preparations
(PB 14 of 2010)

as amended

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

National Health Act 1953

This compilation was prepared on 1 November 2010
taking into account amendments up to PB 95 of 2010

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

Declaration and determination — Drugs and medicinal preparations
(PB 14 of 2010)

Commencement [see Note 1]

1. This instrument commences on 1 April 2010.

Repeal

2. Instrument number PB 113 of 2008 is repealed.

Definitions

3. In this instrument:

“Act” means the National Health Act 1953;

“authorised midwife” has the meaning given by subsection 84(1) of the Act;

“authorised nurse practitioner” has the meaning given by subsection 84(1) of the Act;

“authorised optometrist” has the meaning given by subsection 84(1) of the Act;

“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;

“participating dental practitioner” has the meaning given by subsection 84(1) of the Act;

“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, including where [NP] or [NP] [MW] is included in column 1 with the name of the drug or medicinal preparation, 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.

4AA. 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 and, where “[MW]” is included in column 1 with the name of the drug or medicinal preparation, including where [NP] is also mentioned in column 1, the circumstances (if any) specified in column 3 of Schedule 1 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised midwife, except where [MW] is also mentioned in column 3 of Schedule 1. The [MW] where included in column 1 does not form part of the name of the listed drug.

4AB. Where [MW] is included in column 1 of Schedule 1, and is also mentioned in column 3 of that Schedule with a form of a listed drug, Part VII of the Act applies for that form of the listed drug, and the circumstances (if any) specified in column 3 for that form apply, when prescribed by an authorised midwife or medical practitioner. The [MW] where included in column 3 does not constitute part of the form of the listed drug.

4AC. 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, where “[NP]” is included in column 1 with the name of the drug or medicinal preparation, including where [MW] is also included in column 1 of Schedule 1, 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 an authorised nurse practitioner, except where [NP] is also mentioned in column 3 of Schedule 1. The [NP] where included in column 1 of Schedule 1 or 1A does not form part of the name of the listed drug.

4AD. Where [NP] is included in column 1 of Schedule 1 and is also mentioned in column 3 of Schedule 1 with the circumstances for a listed drug, a form of a listed drug, or the circumstances for a form of a listed drug, Part VII of the Act applies in relation to the listed drug for those circumstances or for that form and the circumstances (if any) specified for that listed drug or for that form of the listed drug apply, when prescribed by an authorised nurse practitioner or medical practitioner. The [NP] when included with a circumstance, or form and strength of a listed drug does not constitute part of the circumstance or form and strength for the listed drug.

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 3 of Schedule 1 or column 2 of Schedule 1A where [NP] is included in column 1 with the name of the drug or medicinal preparation, and including where [MW] is also mentioned in column 1, (in respect of authorised nurse 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, authorised nurse 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, authorised nurse practitioner or authorised optometrist:

(A) in a form approved by the Secretary and completed by the medical practitioner, authorised nurse 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, authorised nurse practitioner or authorised optometrist in accordance with subsubparagraph (i); or

(iii) where the medical practitioner, authorised nurse 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, authorised nurse 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, authorised nurse 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, authorised nurse practitioner or authorised optometrist for alteration before the medical practitioner, authorised nurse 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, authorised nurse 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 nurse practitioner or authorised optometrist, must tell the authorised nurse practitioner or authorised optometrist orally the number that has been allotted to the authorised prescription; and

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

15C. If a medical practitioner or authorised nurse 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

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 [NP]		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 [NP]	—
Acetazolamide [NP]	—
Aciclovir [NP]	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 — initial treatment 1 (patient assessed by CDAI) 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 — initial treatment 2 (patient assessed by CDAI) 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 — initial treatment 1 (patient with short gut syndrome or an ostomy patient) 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 — initial treatment 2 (patient with short gut syndrome or extensive small intestine disease, or an ostomy patient) 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 — initial treatment 1 (patient with extensive small intestine 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:

(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

(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 — initial treatment 1

(patient assessed by CDAI)

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 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 — initial treatment 2

(patient assessed by CDAI)

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 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 — initial treatment 1

(patient with short gut syndrome or an ostomy patient)

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

(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

(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 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 — initial treatment 2

(patient with short gut syndrome or extensive small intestine disease, or an ostomy patient)

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

(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 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);

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 — initial treatment 1

(patient with extensive small intestine disease)

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

(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: