National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 67 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 67 of 2010

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 5 JULY 2010

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 August 2010.

2              Amendment of PB 14 of 2010

Schedule 1 amends PB 14 of 2010.

Schedule 1        Amendments

[1]Schedule 1, omit item dealing with Adalimumab

and substitute:

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):

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):

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):

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

[2]Schedule 1, after item dealing with Amiloride

insert in the columns in the order indicated:

Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid Pyridoxine non-responsive homocystinuria

[3]Schedule 1, omit item dealing with Anakinra

and substitute:

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

[9]Schedule 1, after item dealing with Exemestane

insert in the columns in the order indicated:

Exenatide

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

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

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

 (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests; and

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

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

Initiation of therapy, in combination with metformin and a sulfonylurea, in a patient with type 2 diabetes mellitus who, despite maximally tolerated doses of metformin and a sulfonylurea, has:

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

 (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period; and

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

Continuation of therapy, in combination with metformin and a sulfonylurea, in a patient with type 2 diabetes mellitus where the patient has previously been issued with an authority prescription for exenatide

1. Schedule 1, after item dealing with Glyceryl Trinitrate

insert in the columns indicated:

Golimumab

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 golimumab, 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 golimumab 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 golimumab, 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 golimumab, 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 golimumab 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 golimumab are not eligible to commence treatment with golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab, 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 — initial treatment 3

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

 Initial PBS-subsidised supply for continuing treatment with golimumab, 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 an adult who:

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

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

 (c) has demonstrated a response to golimumab treatment, as specified in the criteria for continuing PBS-subsidised treatment with golimumab; and (d) is receiving treatment with golimumab at the time of application; and

 where the following conditions apply:

 the authority application includes a completed copy of the appropriate Rheumatoid 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 with golimumab, 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 an adult with a documented history of severe active rheumatoid arthritis who was receiving non-PBS-subsidised treatment with golimumab 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 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

Rheumatoid arthritis — continuing treatment

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

 Continuing PBS-subsidised treatment with golimumab, 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 golimumab; and

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

 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 golimumab 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 golimumab, 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

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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 — 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 golimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

 (1) have a documented history of severe active psoriatic arthritis; and

 (2) were receiving treatment with golimumab prior to 1 March 2010; and

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

 (4) are receiving treatment with golimumab at the time of application; 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:

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

 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 with golimumab commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Psoriatic arthritis — continuing treatment

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

 Continuing treatment with golimumab 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 golimumab; and

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

 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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 golimumab 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):

Ankylosing spondylitis — 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 golimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with golimumab prior to 1 March 2010; and

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

 (b) who is receiving treatment with golimumab at the time of application; 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:

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

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

 (ii) a completed BASDAI Assessment Form; and

 (iii) a signed patient acknowledgment form;

 the BASDAI assessment and the ESR and/or CRP measurements provided are 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 with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with golimumab 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 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 — continuing treatment

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

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

 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 golimumab 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 golimumab 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

1. Schedule 1, item dealing with Imatinib

omit from the columns in the order indicated:

Imatinib

Gastrointestinal stromal tumour

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

 Initial PBS-subsidised treatment, for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining; and

 where the following conditions apply:

 patients who have not previously been treated with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour commence treatment at a dose that does not exceed 400 mg per day for at least 3 months;

 patients who have previously been treated with non-PBS-subsidised imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour are eligible to receive up to 3 months treatment at a dose of up to 600 mg per day;

 the application for authorisation includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:

 (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and

 (ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and

 (iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim

and substitute:

Imatinib

Gastrointestinal stromal tumour

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

 Initial PBS-subsidised treatment, for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where patients commence treatment at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:

 (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and

 (ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and

 (iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim

1. Schedule 1, item dealing with Mesalazine

omit from the columns in the order indicated:

In respect of the tablet 250 mg (enteric coated), tablet 500 mg (enteric coated), tablet 500 mg (prolonged release), sachet containing prolonged release granules, 1 g per sachet and sachet containing prolonged release granules, 2 g per sachet:

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

2268

 Crohn's disease where hypersensitivity to sulfonamides exists

2269

 Crohn's disease where intolerance to sulfasalazine exists

and substitute:

In respect of the tablet 250 mg (enteric coated), tablet 500 mg (enteric coated), tablet 500 mg (prolonged release), tablet 1 g (prolonged release), sachet containing prolonged release granules, 1 g per sachet and sachet containing prolonged release granules, 2 g per sachet:

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

2268

 Crohn's disease where hypersensitivity to sulfonamides exists

2269

 Crohn's disease where intolerance to sulfasalazine exists

1. Schedule 1, item dealing with Methylphenidate

omit from the column headed “Circumstances”:

In respect of the capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release):

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

Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours

and substitute:

In respect of the capsule containing methylphenidate hydrochloride 10 mg (modified release), capsule containing methylphenidate hydrochloride 20 mg (modified release), capsule containing methylphenidate hydrochloride 30 mg (modified release) and capsule containing methylphenidate hydrochloride 40 mg (modified release):

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

Treatment of attention deficit hyperactivity disorder (ADHD) in a patient diagnosed between the ages of 6 and 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 8 hours

1. Schedule 1, omit item dealing with Oxaliplatin

and substitute:

Oxaliplatin	In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid
Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil and calcium folinate, following complete resection of the primary tumour

1. Schedule 1, item dealing with Pramipexole

omit from the column headed “Circumstances”:

In respect of the tablet containing pramipexole hydrochloride 1 mg:

Parkinson disease

and substitute:

In respect of the tablet containing pramipexole hydrochloride 1 mg, tablet (extended release) containing pramipexole hydrochloride 375 micrograms, tablet (extended release) containing pramipexole hydrochloride 750 micrograms, tablet (extended release) containing pramipexole hydrochloride 1.5 mg, tablet (extended release) containing pramipexole hydrochloride 3 mg and tablet (extended release) containing pramipexole hydrochloride 4.5 mg:

Parkinson disease

1. Schedule 1, item dealing with Triglycerides—medium chain, formula

omit from the column headed “Circumstances”:

In respect of the sachets containing oral powder 16 g, 25 (MCT Pro-Cal):

and substitute:

In respect of the sachets containing oral powder 16 g, 30 (MCT Pro-Cal):

1. Schedule 1, after item dealing with Vigabatrin

insert in the columns in the order indicated:

Vildagliptin

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

3437

 Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:

 (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with either metformin or a sulfonylurea; or

 (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and

 where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and

 where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated

1. Schedule 2A, after item dealing with Brinzolamide

insert in the columns in the order indicated:

Brinzolamide with timolol	Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy
Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy

1. Schedule 3, after item dealing with Brimonidine

insert in the columns in the order indicated:

Brinzolamide Brinzolamide with Timolol

1. Schedule 3, item dealing with Timolol

insert as next item in the column headed “Allowable compounds” after “Brimonidine with Timolol”:

Brinzolamide with Timolol

1. Schedule 6, omit item dealing with Buprenorphine

1. Schedule 6, omit item dealing with Delavirdine

1. Schedule 6, after item dealing with Tipranavir

insert:

Tocilizumab