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)

Patients with diabetes mellitus not otherwise included

total cholesterol greater than 5.5 mmol per L

Aboriginal or Torres Strait Islander patients;

Patients with hypertension

total cholesterol greater than 6.5 mmol per L;

or

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

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

total cholesterol greater than 6.5 mmol per L

Patients with familial hypercholesterolaemia identified by:

(1) DNA mutation; or

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

Patients with:

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

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

If aged 18 years or less at treatment initiation:

low density lipoprotein cholesterol greater than 4 mmol per L

If aged more than 18 years at treatment initiation:

low density lipoprotein cholesterol greater than 5 mmol per L;

or

total cholesterol greater than 6.5 mmol per L;

or

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

Patients not eligible under the above:

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

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

total cholesterol greater than 7.5 mmol per L;

or

triglyceride greater than 4 mmol per L

Patients not otherwise included

total cholesterol greater than 9 mmol per L;

or

triglyceride greater than 8 mmol per L

Abciximab

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

1716

 Patients undergoing percutaneous coronary balloon angioplasty

1717

 Patients undergoing percutaneous coronary atherectomy

1718

 Patients undergoing percutaneous coronary stent placement

Acamprosate [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:

 (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 — 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:

 (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 — initial treatment 3

 (patient assessed by CDAI)

 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 — continuing treatment

 (patient assessed by CDAI)

 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 — continuing treatment

 (patient with short gut syndrome or an ostomy patient)

 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 — continuing treatment

 (patient with extensive small intestine 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 — initial treatment 3

 (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):

 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 — initial treatment 1

 (new patient or patient recommencing after a break of more than 12 months)

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

 Initial PBS-subsidised treatment with adalimumab, 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 received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

 (c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:

 (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:

 — hydroxychloroquine at a dose of at least 200 mg daily; or

 — leflunomide at a dose of at least 10 mg daily; or

 — sulfasalazine at a dose of at least 2 g daily; or

 (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:

 — hydroxychloroquine at a dose of at least 200 mg daily; and/or

 — leflunomide at a dose of at least 10 mg daily; and/or

 — sulfasalazine at a dose of at least 2 g daily; or

 (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:

 — azathioprine at a dose of at least 1 mg/kg per day; and/or

 — cyclosporin at a dose of at least 2 mg/kg/day; and/or

 — sodium aurothiomalate at a dose of 50 mg weekly; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and

 where the following conditions apply:

 if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;

 the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;

 the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;

 if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;

 failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:

 (a) 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

 (b) either:

 (i) a total active joint count of at least 20 active (swollen and tender) joints; or

 (ii) at least 4 active joints from the following list of major joints:

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

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

 the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;

 if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;

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

 a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

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

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

 Continuation of a course of initial treatment with adalimumab, 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

Rheumatoid arthritis — initial treatment 2

 (change or recommencement after a break of less than 12 months)

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

 Initial PBS-subsidised treatment with adalimumab, 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 biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and

 (c) have not failed previous PBS-subsidised treatment with adalimumab for this condition; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

 where the following conditions apply:

 patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

 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;

 where a patient has received PBS-subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised adalimumab treatment;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than
4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;

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

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

 Continuation of a course of initial treatment with adalimumab, 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 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

Rheumatoid arthritis — continuing treatment

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

 Continuing PBS-subsidised treatment with adalimumab, 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 biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

 where the following conditions apply:

 an adequate response to treatment is defined as:

 (a) 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

 (b) either of the following:

 (i) 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

 (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

 — shoulder and/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 an initial course of treatment are used to determine response to that course, and subsequent courses, 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;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

 if the most recent course of adalimumab therapy is 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;

 if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

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

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

 Continuation of a course of continuing treatment with adalimumab, 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

Psoriatic arthritis — initial treatment 1

 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 received no prior 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; and

 where biological agent means adalimumab, etanercept, golimumab 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 the following:

 (a) 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

 (b) either:

 (i) an active joint count of at least 20 active (swollen and tender) joints; or

 (ii) at least 4 active joints from the following list of major joints:

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

 — shoulder and/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 and a signed patient acknowledgment;

 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment

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

 Continuation of a course of initial treatment with adalimumab 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

Psoriatic arthritis — initial treatment 2

 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 are eligible to receive further therapy with a biological agent; and

 (3) have not failed treatment with adalimumab during the current Treatment Cycle; and

 where biological agent means adalimumab, etanercept, golimumab 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 failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

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

 where a patient has received PBS-subsidised treatment with adalimumab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised adalimumab treatment;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;

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

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

 Continuation of a course 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

Psoriatic arthritis — continuing treatment

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

 Continuing 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:

 (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, etanercept, golimumab 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:

 (a) 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

 (b) either of the following:

 (i) 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

 (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

 — shoulder and/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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;

 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;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

 if the most recent course of adalimumab therapy is 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;

 if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

 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):

 Continuation of a course of continuing 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 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

Ankylosing spondylitis — initial treatment 1

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

 Initial treatment with adalimumab 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 PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment 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 TNF-alfa antagonist therapy 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

 where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and

 where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, 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 by:

 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and

 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;

 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;

 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;

 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;

 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;

 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;

 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;

 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;

 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;

 the application for authorisation includes:

 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

 (ii) a completed BASDAI Assessment Form; and

 (iii) a signed patient acknowledgment form; and

 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;

 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment

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

 Continuation of a course of initial treatment with adalimumab 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

Ankylosing spondylitis — initial treatment 2

 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 tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with adalimumab in the current treatment cycle; and

 where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and

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

 where the following conditions apply:

 a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle;

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

 an assessment of response to the patient’s most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased;

 where the most recent course of TNF-antagonist treatment is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

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

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

 Continuation of a course 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

Ankylosing spondylitis — continuing treatment

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

 Continuing treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and

 where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and

 where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, 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 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;

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

 where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;

 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

 if the most recent course of adalimumab therapy is 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;

 if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

 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):

 Continuation of a course of continuing 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 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

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

Chronic plaque psoriasis (face, hand, foot) — 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 of the face, or palm of a hand or sole of a foot; and

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

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

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

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

Chronic plaque psoriasis (face, hand, foot) — 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:

 (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with adalimumab prior to 1 March 2009; and

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

(c) who have signed a patient 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) who have demonstrated a response as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with adalimumab of psoriasis affecting the face, hand or foot; 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 and face, hand, foot area diagrams 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 PASI assessment is performed on the same affected body area as assessed at baseline or prior to initiation of adalimumab treatment;

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

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

 (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or

 (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value;

 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 and face, hand, foot area diagrams 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 of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with 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

Juvenile idiopathic arthritis — initial treatment 1

 (new patient or patient recommencing after a break of more than 12 months)

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

 Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:

 (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and

 (b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

 (c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:

 (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:

 — hydroxychloroquine at a dose of at least 200 mg daily; or

 — leflunomide at a dose of at least 10 mg daily; or

 — sulfasalazine at a dose of at least 2 g daily; or

 (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:

 — hydroxychloroquine at a dose of at least 200 mg daily; and/or

 — leflunomide at a dose of at least 10 mg daily; and/or

 — sulfasalazine at a dose of at least 2 g daily; or

 (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:

 — azathioprine at a dose of at least 1 mg/kg per day; and/or

 — cyclosporin at a dose of at least 2 mg/kg per day; and/or

 — sodium aurothiomalate at a dose of 50 mg weekly; and

 where bDMARD means adalimumab or etanercept; and

 where the following conditions apply:

 if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;

 the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;

 the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;

 if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;

 failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:

 (a) 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

(b) either:

 (i) an active joint count of at least 20 active (swollen and tender) joints; or

 (ii) at least 4 active joints from the following list:

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

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

 the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;

 if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;

 the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;

 a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;

 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 a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has 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

Juvenile idiopathic arthritis — initial treatment 2

 (change or recommencement after a break of less than 12 months)

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

 Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:

 (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and

 (b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept 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 authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;

 where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;

 a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

 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 a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of 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

Juvenile idiopathic arthritis — initial treatment 3

 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 or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:

 (a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and

 (b) was receiving treatment with adalimumab prior to 1 March 2010; and

 (c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and

 (d) is receiving treatment with adalimumab at the time of application; and

 where the following conditions apply:

the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;

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

 a patient is 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 or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 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

Juvenile idiopathic arthritis — continuing treatment

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

 Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:

 (a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and

 (b) who has demonstrated an adequate response to treatment with adalimumab; and

 (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and

 where bDMARD means adalimumab or etanercept; and

 where the following conditions apply:

 an adequate response to treatment is defined as:

 (a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and

 (b) either of the following:

 (i) an active joint count of fewer than 10 active (swollen and tender) joints; or

 (ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or

 (iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:

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

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

 the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;

 the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

 if the most recent course of adalimumab therapy is 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;

 if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

 a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;

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

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

 Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years 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

Adrenaline [NP]

In respect of the injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000):

—

In respect of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen Jr.), I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior), I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen) and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen):

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

Initial sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, and where the name of the specialist consulted is included in the authority application

Initial sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis

Continuing sole PBS-subsidised supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug

Albendazole [NP]

In respect of the tablet 200 mg [NP]:

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

2446

 Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person

1388

 Strongyloidiasis

3241

 Treatment of hookworm infestation

1525

 Treatment of tapeworm infestation

In respect of the tablet 400 mg:

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

1496

 For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used

Alendronic Acid [NP]

In respect of the tablet 70 mg (as alendronate sodium):

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

3070

 Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated

2645

 Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated

2646

 Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

In respect of the tablet 40 mg (as alendronate sodium):

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

3256

 Symptomatic Paget disease of bone

Alendronic acid with colecalciferol [NP]

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

3070

 Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated

2645

 Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated

2646

 Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Alendronic acid with colecalciferol and calcium [NP]

3070

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

Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated

2645

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated

2646

 Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Alginic acid with calcium carbonate and sodium bicarbonate [NP]

—

Allopurinol [NP]

—

Alprazolam [NP]

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

Panic disorder where other treatments have failed or are inappropriate

Aluminium Hydroxide with Magnesium Hydroxide [NP]

—

Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide [NP]

—

Amantadine [NP]

Parkinson’s disease which is not drug induced

Amiloride [NP]

—

Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid [NP]

Pyridoxine non-responsive homocystinuria

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid [NP]

Tyrosinaemia

Amino acid formula without phenylalanine [NP]

Phenylketonuria

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine [NP]

Phenylketonuria

Amino acid formula with vitamins and minerals without lysine and low in tryptophan [NP]

In respect of the sachets containing oral powder 20 g, 30 (GA gel):

A child aged from 6 months up to 10 years with proven glutaric aciduria type 1

In respect of the oral powder 400 g (GA1 Anamix infant):

An infant or young child with proven glutaric aciduria type 1

In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid):

A child aged less than 9 years with proven glutaric aciduria type 1

Amino acid formula with vitamins and minerals without methionine [NP]

In respect of the oral powder 400 g (HCU Anamix infant):

For infants and very young children with pyridoxine non-responsive homocystinuria

In respect of the sachets containing oral powder 20 g, 30 (HCU gel), sachets containing oral powder 25 g, 30 (HCU express), oral powder 500 g (XMET Maxamaid), oral powder 500 g (XMET Maxamum) and oral liquid 130 mL, 30 (HCU Cooler):

Pyridoxine non-responsive homocystinuria

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine [NP]

Methylmalonic acidaemia

Propionic acidaemia

Amino acid formula with vitamins and minerals without phenylalanine [NP]

Phenylketonuria

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine [NP]

Tyrosinaemia

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine [NP]

Maple syrup urine disease

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid [NP]

Maple syrup urine disease

Amino acids — synthetic, formula [NP]

In respect of the oral powder 400 g (EleCare):

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

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

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

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

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

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

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

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

Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:

 eosinophilic oesophagitis is demonstrated by the following criteria:

 (i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and

 (ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and

 (iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

 the date of birth of the patient is included in the authority application;

 treatment with oral steroids is not commenced during the period of initial treatment

Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:

 response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

 the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment

In respect of the oral powder 400 g (Neocate), oral powder 400 g (Neocate Advance) and oral powder 400 g (Neocate Advance Tropical Flavour):

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

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

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

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

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

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

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

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

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids [NP]

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

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

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

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

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

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

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

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

Amiodarone [NP]

Severe cardiac arrhythmias

Amisulpride [NP]

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

1589

 Schizophrenia

Amitriptyline [NP]

—

Amlodipine [NP]

—

Amlodipine with Atorvastatin [NP]

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are currently receiving treatment with a dihydropyridine calcium channel blocker

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti-anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are intolerant of the side effects of other classes of antihypertensive and/or anti-anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate

Amlodipine with valsartan [NP]

Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

Amlodipine with valsartan and hydrochlorothiazide

Hypertension in a patient who is not adequately controlled with any two of the drugs in the combination

Amoxycillin [NP] [MW]

In respect of the tablet 1 g (as trihydrate):

Acute exacerbations of chronic bronchitis

In respect of the capsule 250 mg (as trihydrate) [MW], capsule 500 mg (as trihydrate) [MW], sachet containing oral powder 3 g (as trihydrate), powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL, powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL, powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL and powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL:

—

Amoxycillin with Clavulanic Acid [NP] [MW]

Infections where resistance to amoxycillin trihydrate is suspected

Infections where resistance to amoxycillin trihydrate is proven

Amphotericin [NP]

—

Ampicillin [NP]

—

Amylopectin, modified long chain [NP]

Glycogen storage disease

Anakinra

Rheumatoid arthritis — initial treatment 1

 (new patient or patient recommencing after a break of more than 12 months)

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

 Initial PBS-subsidised treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and

 (c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:

 (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:

 — hydroxychloroquine at a dose of at least 200 mg daily; or

 — leflunomide at a dose of at least 10 mg daily; or

 — sulfasalazine at a dose of at least 2 g daily; or

 (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:

 — hydroxychloroquine at a dose of at least 200 mg daily; and/or

 — leflunomide at a dose of at least 10 mg daily; and/or

 — sulfasalazine at a dose of at least 2 g daily; or

 (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:

 — azathioprine at a dose of at least 1 mg/kg per day; and/or

 — cyclosporin at a dose of at least 2 mg/kg/day; and/or

 — sodium aurothiomalate at a dose of 50 mg weekly; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and

 where the following conditions apply:

 if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;

 the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;

 the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;

 if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;

 failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:

 (a) 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

 (b) either:

 (i) a total active joint count of at least 20 active (swollen and tender) joints; or

 (ii) at least 4 active joints from the following list of major joints:

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

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

 the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;

 if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;

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

 a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with anakinra for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

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

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

 Continuation of a course of initial treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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

Rheumatoid arthritis — initial treatment 2

 (change or recommencement after a break of less than 12 months)

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

 Initial PBS-subsidised treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and

 (c) have not failed previous PBS-subsidised treatment with anakinra for this condition; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

 where the following conditions apply:

 patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;

 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with anakinra are not eligible to commence treatment with anakinra until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;

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

 where a patient has received PBS-subsidised treatment with anakinra and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS-subsidised anakinra treatment;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised anakinra treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;

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

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

 Continuation of a course of initial treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, 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 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

Rheumatoid arthritis — continuing treatment

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

 Continuing PBS-subsidised treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

 (a) who have a documented history of severe active rheumatoid arthritis; and

 (b) who have demonstrated an adequate response to treatment with anakinra; and

 (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with anakinra; and

 where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and

 where the following conditions apply:

 an adequate response to treatment is defined as:

 (a) 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

 (b) either of the following:

 (i) 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

 (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

 — shoulder and/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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;

 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra;

 the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;

 if the most recent course of anakinra therapy is 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;

 if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;

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

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

 Continuation of a course of continuing treatment with anakinra, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Anastrozole [NP]

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

Apraclonidine

Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy

Aprepitant [NP]

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

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:

 (a) altretamine;

 (b) carmustine;

 (c) cisplatin, when a single dose constitutes a cycle of chemotherapy;

 (d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;

 (e) dacarbazine;

 (f) procarbazine, when a single dose constitutes a cycle of chemotherapy;

 (g) streptozocin; and

 where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:

 (a) arsenic trioxide;

 (b) azacitidine;

 (c) carboplatin;

 (d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;

 (e) cytarabine, at a dose of greater than 1 g per square metre per day;

 (f) dactinomycin;

 (g) daunorubicin;

 (h) doxorubicin;

 (i) epirubicin;

 (j) fotemustine;

 (k) idarubicin;

 (l) ifosfamide;

 (m) irinotecan;

 (n) melphalan;

 (o) methotrexate, at a dose of 250 mg to 1 g per square metre;

 (p) oxaliplatin;

 (q) raltitrexed; and

 where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle

Arginine with carbohydrate [NP]

Urea cycle disorders

Aripiprazole [NP]

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

1589

 Schizophrenia

Arsenic

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

Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction

Artemether with lumefantrine

In respect of the tablet 20 mg-120 mg:

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

Treatment of suspected or confirmed malaria due to Plasmodium falciparum

In respect of the tablet (dispersible) 20 mg-120 mg:

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

Treatment of suspected or confirmed malaria due to Plasmodium falciparum in a patient unable to swallow a solid dosage form of artemether with lumefantrine

Aspirin [NP]

—

Atenolol [NP]

—

Atomoxetine

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

Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride poses an unacceptable medical risk due to the following contraindications as specified in the Therapeutic Goods Administration-approved Product Information:

 (1) the patient has a history of substance abuse or misuse (other than alcohol); and/or

 (2) the patient has comorbid motor tics or Tourette’s Syndrome; and/or

 (3) the patient has comorbid severe anxiety diagnosed according to the DSM-IV

Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride has resulted in the development or worsening of a comorbid mood disorder (that is, anxiety disorder, obsessive compulsive disorder or depressive disorder, diagnosed according to the DSM-IV criteria) of a severity necessitating permanent stimulant treatment withdrawal, or where the combination of stimulant treatment with another agent would pose an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal

Initial sole PBS-subsidised treatment of attention-deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM-IV criteria, where treatment with dexamphetamine sulfate and methylphenidate hydrochloride has resulted in the development of adverse reactions of a severity necessitating permanent treatment withdrawal:

 (1) Adverse effects on growth and weight; and/or

 (2) Adverse effects on sleep including insomnia; and/or

 (3) Adverse effects on appetite including anorexia

Continuing sole PBS-subsidised treatment where the patient has previously been issued with an authority prescription for this drug

Atorvastatin [NP]

For use in accordance with paragraph 16

For use in accordance with paragraph 16 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Atovaquone [NP]

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

1433

 Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy

Atovaquone with proguanil [NP]

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

Treatment of suspected or confirmed Plasmodium falciparum malaria in a patient aged 3 years or older where quinine containing regimens are inappropriate

Atropine [NP]

—

Auranofin [NP]

—

Aurothiomalate [NP]

—

Azathioprine [NP]

—

Azithromycin [NP]

In respect of the tablet 500 mg (as dihydrate):

Uncomplicated urethritis due to Chlamydia trachomatis

Uncomplicated cervicitis due to Chlamydia trachomatis

Trachoma

In respect of the powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL:

Trachoma

Baclofen [NP]

—

Balsalazide [NP]

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

1708

 Ulcerative colitis where hypersensitivity to sulfonamides exists

1709

 Ulcerative colitis where intolerance to sulfasalazine exists

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

Treatment of carcinoma in situ of the urinary bladder

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

Primary and relapsing superficial urothelial carcinoma of the bladder