COMMONWEALTH OF AUSTRALIA
Instrument number PB 74 of 2010
National Health (Highly specialised drugs program for public hospitals) Special Arrangements Amendment Instrument 2010 (No. 1)
 
I, LINDA JACKSON, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.
Dated 27 July 2010
 
 
 
 
LINDA JACKSON
Assistant Secretary
Access and Systems Branch
Department of Health and Ageing
Amendment Special Arrangements — Highly Specialised Drugs Program for Public Hospitals
1              Commencement
                This instrument commences on 1 August 2010.
2              Amendment of PB 63 of 2010
                Schedule 1 amends PB 63 of 2010.
Schedule 1                   Amendments
[1]                 Paragraph 3(1) from CAR drug (Complex Authority Required drug) means any of the following:
omit:
                         (k) sitaxentan.  
and substitute:
                         (k) sitaxentan;
                         (l) tocilizumab.
[2]                 Paragraph 3(1) from medication for the treatment of HIV or AIDS means any of the following:
(a)   omit subparagraph (i) delavirdine
(b)  re-name subsequent subparagraphs as (i) to (zh)
[3]                 Paragraph 21(2)(d)
omit:
                         Crohn disease
and substitute:
                         Crohn disease or fistulating Crohn disease
[4]                 Paragraph 21(2)(f)
omit the fullstop and substitute a semicolon
[5]                 After paragraph 21(2)(f)
insert the following paragraph:
(g) for tocilizumab - a quantity of units that are sufficient, based on the weight of the patient and taking into account whether any other strength injections will contribute part of the dose, to provide for the whole or part of a single dose of 8 mg per kg.
[6]                 Paragraph 23(2)(e)
omit:
                   Crohn disease
and substitute:
                         Crohn disease or fistulating Crohn disease
[7]                 Paragraph 23(2)(k)
omit the fullstop and substitute a semicolon
[8]                 After paragraph 23(2)(k)
insert the following paragraphs:
(l) for tocilizumab, for the treatment of adults with severe active rheumatoid arthritis in accordance with the circumstances specified in Schedule 1:
(i)      if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised - up to 3 repeat supplies;
(ii)    If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised - up to 5 repeat supplies.
[9]                 Schedule 1, omit item dealing with Abatacept
and substitute:
Abatacept
Rheumatoid arthritis —  initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

 
Initial PBS-subsidised treatment with abatacept, 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 is made in writing and 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 abatacept 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;

 
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis —  initial treatment 2
(change or recommencement after a break of less than 12 months)

 
Initial PBS-subsidised treatment with abatacept, 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 abatacept 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 abatacept are not eligible to commence treatment with abatacept 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 is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

 
where a patient has received PBS-subsidised treatment with abatacept 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 abatacept 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 abatacept 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;

 
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis —  continuing treatment

 
Continuing PBS-subsidised treatment with abatacept, 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 abatacept; and

 
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with abatacept; 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); and/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 is made in writing and 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 abatacept;

 
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 abatacept 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

[10]             Schedule 1, omit item dealing with Delavirdine
[11]             Schedule 1, omit item dealing with Infliximab
and substitute:

Infliximab
Ankylosing spondylitis  —  initial treatment 1

 
Initial treatment with infliximab 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 is made in writing and 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 18 weeks of treatment;

 
if less than 18 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 18 weeks of treatment in total may be submitted by telephone

 
Ankylosing spondylitis  —  initial treatment 2

 
Initial treatment, or recommencement of treatment, with infliximab 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 infliximab 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 is made in writing and 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 an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;

 
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 18 weeks of treatment;

 
if less than 18 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 18 weeks of treatment in total may be submitted by telephone

 
Ankylosing spondylitis  —  continuing treatment

 
Continuing treatment with infliximab 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 infliximab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with infliximab; 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 is made in writing and 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 infliximab;

 
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 infliximab therapy is an 18-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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis  —  initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

 
Initial PBS-subsidised treatment with infliximab, 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 is made in writing and 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 infliximab 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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis  —  initial treatment 2
(change or recommencement after a break of less than 12 months)

 
Initial PBS-subsidised treatment with infliximab, 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 infliximab 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 infliximab are not eligible to commence treatment with infliximab 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 is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

 
where a patient has received PBS-subsidised treatment with infliximab 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 infliximab 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 infliximab treatment is a 22-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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis  —  continuing treatment

 
Continuing PBS-subsidised treatment with infliximab, 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 infliximab; and

 
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with infliximab; 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); and/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 is made in writing and 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 infliximab;

 
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 infliximab therapy is a 22-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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

 
Psoriatic arthritis  —  initial treatment 1

 
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); and/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 is made in writing and 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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Psoriatic arthritis  —  initial treatment 2

 
Initial treatment, or recommencement of treatment, with infliximab 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 infliximab 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 is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

 
where a patient has received PBS-subsidised treatment with infliximab 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 infliximab 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 infliximab treatment is a 22-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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Psoriatic arthritis  —  continuing treatment

 
Continuing treatment with infliximab 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 infliximab; and

 
(3) who, at the time of application, demonstrate an adequate response to treatment with infliximab; 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 infliximab 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); and/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 is made in writing and 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 infliximab;

 
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 infliximab therapy is a 22-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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

 
Crohn disease — initial treatment 1
(adult patient assessed by CDAI)

 
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in 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 is made in writing and 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 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — initial treatment 2
(adult patient assessed by CDAI)

 
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in 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 infliximab 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 is made in writing and 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 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — continuing treatment
(adult patient assessed by CDAI)

 
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in 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 infliximab; 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 infliximab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150;

 
the application for authorisation is made in writing and 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 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

 
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 infliximab, 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

 
Crohn disease — initial treatment 1
(adult patient - short gut syndrome or an ostomy patient)

 
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in 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 infliximab;

 
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 is made in writing and 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 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — initial treatment 2
(adult patient - short gut syndrome, extensive small intestine disease, or an ostomy patient)

 
Initial treatment, or recommencement of treatment, with infliximab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in 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 infliximab 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 is made in writing and 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 infliximab 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 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — continuing treatment
(adult patient - short gut syndrome or an ostomy patient)

 
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in 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 infliximab; 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 infliximab 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 is made in writing and 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 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

 
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 infliximab, despite demonstrating a response as defined above;

 
the same baseline criterion used to determine response to an initial course of infliximab 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

 
Crohn disease — initial treatment 1
(adult patient - extensive small intestine disease)

 
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in 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 infliximab;

 
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 is made in writing and 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 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — continuing treatment
(adult patient - extensive small intestine disease)

 
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in 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 infliximab; 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 infliximab 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 is made in writing and 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 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

 
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 infliximab, despite demonstrating a response as defined above;

 
the same baseline criterion used to determine response to an initial course of infliximab 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

 
Crohn disease — initial treatment 3
(adult patient assessed by CDAI)

 
Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in 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 infliximab prior to 7 March 2007; and

 
(b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with infliximab; 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 infliximab; 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 infliximab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150;

 
the application for authorisation is made in writing and 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 infliximab;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
a patient may qualify for PBS-subsidised treatment under this restriction once only

 
Crohn disease — initial treatment 3
(adult patient - short gut syndrome, extensive small intestine disease, or an ostomy patient)

 
Commencement of a treatment cycle with an initial PBS-subsidised course of infliximab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in 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 infliximab prior to 7 March 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 infliximab 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 infliximab 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 is made in writing and 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 infliximab;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
a patient may qualify for PBS-subsidised treatment under this restriction once only

 
Crohn disease — initial treatment
(paediatric patient)

 
Initial PBS-subsidised treatment by a gastroenterologist, paediatrician, consultant physician in internal medicine specialising in gastroenterology or consultant physician in general medicine specialising in gastroenterology, of a patient aged 6 to 17 years inclusive with moderate to 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) whose parent or authorised guardian has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if the patient does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

 
(c) has failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:

 
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period;

 
(ii) an 8 week course of enteral nutrition;

 
(iii) 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 10 mg per square metre weekly for 3 or more months; and

 
where the following conditions apply:

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

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

 
failure to achieve an adequate response is indicated by severity of disease activity which results in a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30, 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;

 
the most recent PCDAI assessment is no more than 1 month old at the time of 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 application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient’s condition; and

 
(ii) details of previous systemic drug therapy (dosage, date of commencement and duration of therapy), or dates of enteral nutrition; and

 
(iii) the signed patient acknowledgement;

 
a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

 
Crohn disease — continuing treatment
(patient initiated on PBS-subsidised treatment as a paediatric patient)

 
Continuing PBS-subsidised treatment by a gastroenterologist, paediatrician, consultant physician in internal medicine specialising in gastroenterology, consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of moderate to severe refractory Crohn disease; and

 
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and

 
(c) qualified for initial PBS-subsidised therapy as a paediatric patient aged from 6 to 17 years inclusive; and

 
where the following conditions apply:

 
an adequate response to infliximab treatment is defined as a reduction in Paediatric Crohn Disease Activity Index (PCDAI) Score by at least 15 points as compared to baseline and a total PCDAI score of 30 points or less;

 
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition;

 
the PCDAI assessment is no more than 1 month old at the time of application;

 
the PCDAI 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 3 dose initial course, the assessment is made up to 12 weeks after the first dose (6 weeks following the third dose);

 
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 infliximab, despite demonstrating a response as defined above;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response;

 
patients who fail to demonstrate or sustain a response to treatment with infliximab for Crohn disease as specified in the criteria for continuing treatment with infliximab are not eligible to receive PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

 
Crohn disease — initial treatment
(paediatric patient - previous treatment not PBS-subsidised)

 
Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, paediatrician, consultant physician in internal medicine specialising in gastroenterology, consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient aged 6 to 17 years inclusive who:

 
(a) has a documented history of moderate to severe refractory Crohn disease and was receiving treatment with infliximab prior to 4 July 2007; and

 
(b) had a Paediatric Crohn Disease Activity Index (PCDAI) Score of greater than 30 prior to commencing treatment with infliximab; and

 
(c) whose parent or authorised guardian has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the patient does 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 infliximab; and

 
where the following conditions apply:

 
an adequate response to infliximab treatment is defined as a reduction in Paediatric Crohn Disease Activity Index (PCDAI) Score by at least 15 points as compared to baseline and a total PCDAI score of 30 points or less;

 
the application for authorisation is made in writing and 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 Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition; and

 
(ii) the signed patient acknowledgement;

 
the current PCDAI assessment is no more than 1 month old at the time of application;

 
the baseline PCDAI assessment is from immediately prior to commencing treatment with infliximab;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 24 weeks of therapy in total may be submitted by telephone;

 
a patient may qualify for PBS-subsidised treatment under this restriction once only

 
Fistulising Crohn disease  —  initial treatment

 
Initial PBS-subsidised treatment with infliximab, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:

 
(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 an externally draining enterocutaneous or rectovaginal fistula; 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

 
where the following conditions apply:

 
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and

 
(ii) a signed patient acknowledgement;

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

 
a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone

 
Fistulising Crohn disease  —  recommencement of PBS-subsidised treatment

 
Re-initiation of PBS-subsidised treatment of complex refractory fistulising Crohn disease, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:

 
(a) has a documented history of complex refractory fistulising Crohn disease; and

 
(b) has an externally draining enterocutaneous or rectovaginal fistula; and

 
(c) has previously received PBS-subsidised infliximab treatment for a draining enterocutaneous or rectovaginal fistula; and

 
(d) either:

 
(i) has demonstrated or sustained an adequate response to the most recent course of PBS-subsidised treatment with infliximab for this condition; or

 
(ii) has failed to demonstrate or sustain an adequate response to PBS-subsidised treatment with infliximab for this condition and 12 months have elapsed from the date on which treatment was ceased; and

 
where the following conditions apply:

 
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition;

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

 
a course re-initiating PBS-subsidised treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;

 
if a supply insufficient for 3 doses is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete the initial course of 3 doses may be submitted by telephone;

 
a patient who fails to respond to a course of PBS-subsidised infliximab for the treatment of complex refractory fistulising Crohn disease is not eligible to receive further PBS-subsidised treatment with infliximab for this condition within 12 months of the date on which treatment was ceased

 
Fistulising Crohn disease  —  initial PBS-subsidised treatment (previous infliximab treatment non-PBS-subsidised)

 
Initial PBS-subsidised supply for continuing treatment with infliximab, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:

 
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with infliximab prior to 1 March 2010; and

 
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with infliximab; 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 criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

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

 
(e) has demonstrated or sustained an adequate response to treatment with infliximab; and

 
where the following conditions apply:

 
an adequate response to infliximab treatment is defined as:

 
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or

 
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;

 
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) a completed current Fistula Assessment form including the date of assessment of the patient's condition; and

 
(ii) a signed patient acknowledgement;

 
the current fistula assessment is no more than 1 month old at the time of application;

 
the baseline fistula assessment is from immediately prior to commencing treatment with infliximab;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;

 
a patient is eligible for PBS-subsidised treatment under this restriction once only

 
Fistulising Crohn disease  —  continuing treatment

 
Continuing PBS-subsidised treatment with infliximab, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of complex refractory fistulising Crohn disease; and

 
(b) has demonstrated or sustained an adequate response to treatment with infliximab; and

 
where the following conditions apply:

 
an adequate response is defined as:

 
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or

 
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;

 
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;

 
the fistula 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 3 dose initial course, the assessment is made up to 12 weeks after the first dose (up to 6 weeks following the third dose);

 
where an assessment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with infliximab;

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

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;

 
patients are eligible to receive continuing infliximab treatment in courses of up to 24 weeks providing they continue to sustain the response

 
Chronic plaque psoriasis (whole body) — initial treatment 1

 
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 is made in writing and 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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Chronic plaque psoriasis (whole body) — initial treatment 2

 
Initial treatment, or recommencement of treatment, with infliximab 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 infliximab 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 infliximab 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 infliximab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; 

 
the application for authorisation is made in writing and 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 22 weeks of treatment; 

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Chronic plaque psoriasis (whole body) — continuing treatment

 
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 infliximab; and

 
(c) who have demonstrated an adequate response to their most recent course of treatment with infliximab; 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 infliximab 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 22-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 infliximab; 

 
the application for authorisation is made in writing and 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; 

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

 
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1

 
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 is made in writing and 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 22 weeks of treatment; 

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2

 
Initial treatment, or recommencement of treatment, with infliximab 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 infliximab 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 infliximab 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 infliximab treatment was submitted to the Medicare Australia CEO within 1 month of cessation of that treatment; 

 
the application for authorisation is made in writing and 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 22 weeks of treatment;

 
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Chronic plaque psoriasis (face, hand, foot) — continuing treatment

 
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 infliximab; and

 
(c) who have demonstrated an adequate response to their most recent course of treatment with infliximab; 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 infliximab 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 22-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 infliximab;

 
the application for authorisation is made in writing and 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; 

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

[12]             Schedule 1, omit item dealing with Raltegravir
and substitute:

Raltegravir
3507
Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus infection in patients with CD4 cell counts of less than 500 per cubic millimetre;

 
3508
Treatment, in combination with other antiretroviral agents, of human immunodeficiency virus infection in patients with viral load of greater than 10,000 copies per mL

[13]             Schedule 1, omit item dealing with Rituximab
and substitute:

Rituximab
Rheumatoid arthritis  —  initial treatment 1
(patient recommencing after a break of more than 12 months)

 
Initial PBS-subsidised treatment with rituximab, 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 failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist; and

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

 
(d) 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 is made in writing and 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 rituximab 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 2 infusions

 
Rheumatoid arthritis  —  initial treatment 2
(change or recommencement after a break of less than 12 months)

 
Initial PBS-subsidised treatment with rituximab, 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 failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist; and

 
(c) 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

 
(d) have not failed previous PBS-subsidised treatment with rituximab 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;

 
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

 
where a patient has received PBS-subsidised treatment with rituximab 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 rituximab treatment;

 
the response assessment included in the application is made at least 12 weeks after the first infusion of the course and is provided to the Medicare Australia CEO no later than 4 weeks from the date of assessment;

 
a course of initial treatment is limited to a maximum of 2 infusions

 
Rheumatoid arthritis  —  continuing treatment

 
Continuing PBS-subsidised treatment with rituximab, 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 rituximab; and

 
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with rituximab; 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); and/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 is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

 
a patient is eligible to receive a further course of treatment (every 24 weeks) with this agent providing they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab, and the demonstration of response is submitted to the Medicare Australia CEO within 4 weeks of assessment;

 
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 2 infusions;

 
a patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, is eligible to receive a further course of rituximab under the continuing treatment restriction

[14]             Schedule 1, omit item dealing with Tipranavir
and substitute:

Tipranavir
In respect of the capsule 250 mg:

 
3418
Treatment, in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily, of human immunodeficiency virus (HIV) infection in antiretroviral experienced adults with:

 
(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and /or

 
(b) CD4 cell counts of less than 500 per cubic millimetre.

 
Patients must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:

 
(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and

 
(ii) at least 1 nucleoside reverse transcriptase inhibitor; and

 
(iii) at least 2 protease inhibitors

 
In respect of the oral liquid 100 mg per mL, 95 mL:

 
3501
Treatment, in combination with other antiretroviral agents, and co-administered with ritonavir, of human immunodeficiency virus (HIV) infection in an antiretroviral experienced patient with:

 
(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or

 
(b) CD4 cell counts of less than 500 per cubic millimetre.

 
Patients must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens, including regimens with at least

 
(i) 1 non-nucleoside reverse transcriptase inhibitor,

 
(ii) 1 nucleoside reverse transcriptase inhibitor, and

 
(iii) at least 2 protease inhibitors

[15]             Schedule 1, after item dealing with Tipranavir
insert in the columns in the order indicated:
Tocilizumab
Rheumatoid arthritis  —  initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)

 
Initial PBS-subsidised treatment with tocilizumab, 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 is made in writing and 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 tocilizumab 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;

 
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis  —  initial treatment 2
(change or recommencement after a break of less than 12 months)

 
Initial PBS-subsidised treatment with tocilizumab, 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 tocilizumab 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 tocilizumab are not eligible to commence treatment with tocilizumab 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 is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;

 
where a patient has received PBS-subsidised treatment with tocilizumab 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 tocilizumab 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 tocilizumab 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;

 
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

 
Rheumatoid arthritis  —  initial treatment 3

 
Initial PBS-subsidised supply for continuing treatment with tocilizumab, 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 tocilizumab prior to 1 July 2009; and

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

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

 
where the following conditions apply:

 
the authority application is made in writing and includes a completed copy of the appropriate 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone;

 
a patient is eligible for PBS-subsidised treatment under the above criteria once only

 
Rheumatoid arthritis  —  continuing treatment

 
Continuing PBS-subsidised treatment with tocilizumab, 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 tocilizumab; and

 
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with tocilizumab; 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); and/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 is made in writing and 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 tocilizumab;

 
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 tocilizumab 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;

 
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

[16]             Schedule 2, omit item dealing with Delavirdine
[17]             Schedule 2, item dealing with Everolimus
omit:
 
0.25mg (dispersible)
Oral
360
5
Certican
[18]             Schedule 2, item dealing with Ritonavir
insert as first entry in the columns in the order indicated:
 
Tablet 100 mg
Oral
720
5
Norvir
[19]             Schedule 2, item dealing with Tipranavir
insert as next entry in the columns in the order indicated:
 
Oral liquid 100 mg per mL, 95 mL
Oral
7
5
Aptivus
[20]             Schedule 2, after item dealing with Tipranavir
insert in the columns in the order indicated:

Tocilizumab
Concentrate for injection 80 mg in 4 mL
Injection
1
. .
Actemra

 
Concentrate for injection 200 mg in 10 mL
Injection
1
. .
Actemra

 
Concentrate for injection 400 mg in 20 mL
Injection
1
. .
Actemra

[21]             Schedule 2, item dealing with Valganciclovir
insert as next entry in the columns in the order indicated:
 
Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL
Oral
11
5
Valcyte
[22]             Schedule 3, item dealing with Cyclosporin in the form Capsule 25 mg
(a) omit from the column headed “Approved price”:
                         39.98
and substitute:
                         39.17
(b) omit from the column headed “Approved price”:
                         40.93
and substitute:
                         40.11
[23]             Schedule 3, item dealing with Cyclosporin in the form Capsule 50 mg
(a) omit from the column headed “Approved price”:
                         83.17
and substitute:
                         81.51
(b) omit from the column headed “Approved price”:
                         84.20
and substitute:
                         82.52
[24]             Schedule 3, item dealing with Cyclosporin in the form Capsule 100 mg
(a) omit from the column headed “Approved price”:
                         169.46
and substitute:
                         166.09
(b) omit from the column headed “Approved price”:
                         170.50
and substitute:
                         167.09
 
 
 
 
 
 
 
 
 
 
 
 
Note
 
1.     All legislative instruments and compilations are registered on the Federal Register of
        Legislative Instruments kept under the Legislative Instruments Act 2003.  See
           http://www.frli.gov.au.