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National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 65 of 2008)

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COMMONWEALTH OF AUSTRALIA
Instrument number PB 65 of 2008
Amendment special arrangements under subsection 100(1) of the National Health Act 1953
I, ANDREW MITCHELL, Acting Assistant Secretary, Pharmaceutical Evaluation 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                                                                   3 JUNE                 2008
ANDREW MITCHELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment Special Arrangements — Highly Specialised Drugs Program
1              Commencement
                This instrument commences on 1 July 2008.
2              Amendment of PB 92 of 2007
                Schedule 1 amends PB 92 of 2007.
Schedule 1        Amendments
 
[1]                       Subparagraph 2(h)
insert in the list in alphabetical order:
 
                   raltegravir
[2]                       Subparagraph 14(b)
insert after “14D”:
 
                   , 14E
 
[3]                        Paragraph 14A
omit full stop and substitute a semicolon after subparagraph (f) and insert new subparagraphs:
(g)         in the case of a prescription for the highly specialised drug "cinacalcet", the supply of a quantity of number of units of the highly specialised drug sufficient to provide for 4 weeks treatment at a dose of 30 to 180 mg per day;
 (h)    in the case of a prescription for the highly specialised drug “natalizumab”, the supply of a single infusion.
 
[4]                        Paragraph 14B
omit full stop and substitute a semicolon after subparagraph (k) and insert new subparagraph:
(l)            in the case of a prescription for the highly specialised drug “natalizumab” for the continuing treatment of clinically definite relapsing-remitting multiple sclerosis, up to 2 repeat supplies of the highly specialised drug.
 
[5]                        Paragraph 14D:
insert after the text “1 repeat”:
supply
 
[6]                        After paragraph 14D:
insert new paragraph:
14E.  The Medicare Australia CEO must not authorise the supply of the highly specialised drug “cinacalcet” to be repeated except in the case of a prescription for management of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism and whose treatment is in the maintenance phase, in which case up to 5 repeat supplies may be authorised.
[7]                       Schedule 1, item dealing with Adefovir
omit all text from the column headed “Circumstances” and substitute:
 
 
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(1) (a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels 1 log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
(2) Female patients of childbearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
[8]                       Schedule 1, after item dealing with Cidofovir
insert in the columns in the order indicated:
Cinacalcet
Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 50 pmol per L, not responding to conventional therapy
Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with intact parathyroid hormone (iPTH) of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L, not responding to conventional treatment
 
[9]                       Schedule 1, item dealing with Entecavir
omit all text from the column headed “Circumstances” and substitute:
 
In respect of the tablet containing entecavir monohydrate 0.5 mg:
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy)
(2) (a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
In respect of the tablet containing entecavir monohydrate 1 mg:
Patients with chronic hepatitis B who have failed lamivudine therapy and who satisfy all of the following criteria:
(1) (a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
[10]                  Schedule 1, item dealing with Filgrastim
omit all text from the column headed “Circumstances” and substitute:
 
For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia
Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy
Mobilisation of peripheral blood progenitor cells, in a normal volunteer, for use in allogeneic transplantation
A patient receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation
A patient with a non-myeloid malignancy receiving marrow-ablative chemotherapy and subsequent autologous peripheral blood progenitor cell transplantation
A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient with severe congenital neutropenia (absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, and in whom a bone marrow examination has shown evidence of maturational arrest of the neutrophil lineage)
A patient with severe chronic neutropenia (absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, or evidence of neutrophil dysfunction, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months))
A patient with chronic cyclic neutropenia (absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, and, either having experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics, or having recurrent clinically significant infections (a minimum of 3 in the previous 12 months))
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in:
(a) acute lymphoblastic leukaemia; or
(b) breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) ; or
(c) germ cell tumours; or
(d) infants and children with CNS tumours; or
(e) neuroblastoma; or
(f) non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen) ; or
(g) relapsed Hodgkin disease; or
(h) sarcoma
 
[11]                  Schedule 1, item dealing with Iloprost
omit from the column headed “Circumstances” (wherever occurring):
                   for up to 6 months, of adult patients
and substitute:
                   for up to 6 months, of patients
[12]                  Schedule 1, item dealing with Infliximab
omit all text from the column headed “Circumstances” and substitute:

Infliximab
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

 
(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and

 
(b) who has at least 2 of the following:

 
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or

 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or

 
 (iii) limitation of chest expansion relative to normal values for age and gender; and

 
(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and

 
(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

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

 
where the following conditions apply:

 
failure to achieve an adequate response is demonstrated by:

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

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

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

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

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

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

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

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

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

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

 
the application for authorisation 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 18 weeks of therapy in total may be submitted by telephone

 
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 treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy 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, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
where the following conditions apply:

 
a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

 
the application is accompanied by the results of the patient’s most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

 
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

 
(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 
(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 
if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

 
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 18 weeks of treatment;

 
if less than 18 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 18 weeks of therapy in total may be submitted by telephone

 
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with infliximab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was 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, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

 
where the following conditions apply:

 
a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

 
response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:

 
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

 
(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

 
(c) an ESR or CRP measurement reduced by at least 20% from baseline;

 
if the patient commenced treatment with infliximab prior to 1 March 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

 
(a) an ESR measurement no greater than 25 mm per hour; or 

 
(b) a CRP measurement no greater than 10 mg per L;

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

 
the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;

 
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

 
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
(b) (i) if the course of therapy is an 18 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

 
(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

 
the application for authorisation is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;

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

 
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

 
Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

 
(a) have severe active rheumatoid arthritis; and

 
(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and

 
(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

 
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

 
failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

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

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

 
all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

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

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

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

 
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;

 
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 22 weeks of treatment;

 
if less than 22 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 22 weeks of treatment in total may be submitted by telephone

 
Initial treatment, or recommencement of treatment, with infliximab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

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

 
(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and

 
(c) have not failed previous PBS-subsidised treatment with infliximab during this Treatment Cycle; and

 
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

 
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; 

 
patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle; 

 
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:

 
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised infliximab treatment; and

 
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

 
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 22-week initial treatment course; and 

 
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

 
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with 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 and, in the case of patients recommencing therapy with infliximab in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised infliximab 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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Continuing treatment with infliximab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

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

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

 
(c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with infliximab; and

 
where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; 

 
patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

 
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

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

 
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

 
a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

 
(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 
(b) if the course of therapy is a 22-week initial treatment course, the assessment of response is made following a minimum of 12 weeks 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, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

 
if the most recent course of infliximab therapy was 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;

 
the patient has not failed to demonstrate response to a course of PBS-subsidised infliximab in this Treatment Cycle; 

 
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 treatment in total may be submitted by telephone

 
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

 
(1) have severe active psoriatic arthritis; and

 
(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

 
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and

 
(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

 
(5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

 
where biological agent means adalimumab or etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

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

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

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

 
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

 
if intolerance to treatment with the regimens specified at (3) 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 which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

 
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 22 weeks of treatment;

 
if less than 22 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 22 weeks of uninterrupted therapy may be submitted by telephone

 
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 who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and

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

 
where biological agent means adalimumab or etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

 
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with infliximab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

 
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with infliximab, to their most recent course of PBS-subsidised infliximab treatment; and

 
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

 
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 22 week initial treatment course; and

 
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

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

 
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 22 weeks of treatment;

 
if less than 22 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 22 weeks of uninterrupted therapy may be submitted by telephone

 
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of infliximab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

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

 
(2) were receiving treatment with infliximab prior to 16 March 2006; and

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

 
(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

 
where biological agent means adalimumab or etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and 

 
where the following conditions apply:

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

 
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 24 weeks of uninterrupted therapy may be submitted by telephone;

 
patients are eligible for PBS-subsidised treatment under the above criteria once only

 
Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:

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

 
(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with infliximab; and

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

 
where biological agent means adalimumab or etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 
where the following conditions apply:

 
an adequate response to treatment with infliximab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

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

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

 
the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

 
the authority application 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, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

 
if the most recent course of infliximab therapy was 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;

 
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 24 weeks of uninterrupted therapy may be submitted by telephone

 
Initial PBS-subsidised treatment by a gastroenterologist or paediatrician of a patient aged 6 to 17 years inclusive with moderate to severe refractory Crohn’s disease who satisfies the following criteria:

 
(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; 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’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed current Paediatric Crohn’s 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;

 
a PCDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

 
where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

 
Continuing PBS-subsidised treatment by a gastroenterologist, paediatrician or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of moderate to severe refractory Crohn’s 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’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the completed Paediatric Crohn’s 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;

 
if the application is the first application for continuing treatment with infliximab a PCDAI assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

 
the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

 
where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be 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’s 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

 
Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, paediatrician or 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’s disease and was receiving treatment with infliximab prior to 4 July 2007; and

 
(b) had a Paediatric Crohn’s 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’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed current and baseline Paediatric Crohn’s 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;

 
where a baseline PCDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;

 
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;

 
the assessment of the patient’s response to this course of therapy must be made within the 4 weeks prior to completion of the course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

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

 
Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

 
(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; and

 
(b) 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

 
(c) has failed to achieve an adequate response to prior systemic therapy including:

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

 
(ii) immunosuppressive therapy including:

 
― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

 
― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

 
― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

 
where the following conditions apply:

 
if treatment with any of the drugs mentioned at (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 a severity of disease activity which results in a Crohn’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed current Crohn’s 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 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;

 
a CDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

 
where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

 
Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of severe refractory Crohn’s disease; and

 
(b) 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 Crohn’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the completed Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with 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;

 
if the application is the first application for continuing treatment with infliximab a CDAI assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

 
the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

 
where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be 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’s 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

 
Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

 
(a) has confirmed Crohn’s disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; 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 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 drug therapy including:

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

 
(ii) immunosuppressive therapy including:

 
― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

 
― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

 
― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

 
where the following conditions apply:

 
if treatment with any of the drugs mentioned at (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 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; 

 
any 1 of the above criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction;

 
the same baseline criterion used to determine response to the initial course of infliximab treatment must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy;

 
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s 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 or tests 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 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;

 
the assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

 
where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

 
Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of severe refractory Crohn’s 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 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’s Disease PBS Authority Application - Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test or tests 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;

 
if the application is the first application for continuing treatment with infliximab an assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

 
the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

 
where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be 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;

 
any 1 of the criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy;

 
the same baseline criterion used to determine response to the initial course of infliximab treatment must be used to determine response, and thus eligibility for continued PBS-subsidised therapy, to all subsequent courses of continuing 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, 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’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to recommence PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

 
Initial PBS-subsidised treatment by a gastroenterologist of a patient with severe refractory Crohn’s disease who satisfies the following criteria:

 
(a) has confirmed Crohn’s disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist; 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 signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and

 
(d) has failed to achieve an adequate response to prior systemic therapy including:

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

 
(ii) immunosuppressive therapy including:

 
― azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

 
― 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

 
― methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

 
where the following conditions apply:

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

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

 
failure to achieve an adequate response is indicated by 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’s 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;

 
any 1 of the above criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction;

 
the same baseline criterion used to determine response to the initial course of infliximab treatment must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy;

 
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn’s 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 or tests nominated as the response criterion, if relevant; or

 
(2) the completed current Crohn’s Disease Activity Index (CDAI) calculation sheets 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 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;

 
the assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course;

 
where a response assessment is not undertaken and submitted to the Medicare Australia CEO within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab

 
Continuing PBS-subsidised treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of severe refractory Crohn’s disease with extensive intestinal inflammation affecting more than 50cm of the small intestine; and

 
(b) 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 reduction in Crohn’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with the date of the assessment of the patient’s condition; or

 
(ii) the reports and dates of the pathology test or diagnostic imaging test or tests used to assess response to therapy; or

 
(iii) the date of clinical assessment;

 
the CDAI assessment, where relevant, is no more than 1 month old at the time of application;

 
if the application is the first application for continuing treatment with infliximab an assessment of the patient’s response to the initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated, and submitted to the Medicare Australia CEO no later than 1 month from the date of completion of this initial course of treatment;

 
the assessment of the patient’s response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

 
where an assessment is not submitted to the Medicare Australia CEO within these timeframes the patient will be 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;

 
any 1 of the criteria indicating failure to achieve an adequate response to prior therapy may be used to determine response to an initial course of infliximab treatment and eligibility for continued therapy;

 
the same baseline criterion used to determine response to the initial course of infliximab treatment must be used to determine response, and thus eligibility for continued PBS-subsidised therapy, to all subsequent courses of continuing 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, 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’s disease as specified in the criteria for continuing treatment with infliximab are not eligible to recommence PBS-subsidised treatment with this drug within 12 months of the date on which treatment was ceased

 
Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of severe refractory Crohn’s disease and was receiving treatment with infliximab prior to 7 March 2007; and

 
(b) had a Crohn’s 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 the following conditions apply:

 
an adequate response to infliximab treatment is defined as a reduction in Crohn’s 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed current and baseline Crohn’s Disease Activity Index (CDAI) Score calculation sheet along with 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;

 
where a baseline CDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;

 
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;

 
the assessment of the patient’s response to this course of therapy must be made within the 4 weeks prior to completion of the course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

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

 
Initial PBS-subsidised supply for continuing treatment by a gastroenterologist, or consultant physician in consultation with a gastroenterologist, of a patient who:

 
(a) has a documented history of severe refractory Crohn’s 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 the following conditions apply:

 
an adequate response to infliximab treatment is defined as:

 
(a) a reduction in Crohn’s Disease Activity Index (CDAI) Score to no greater then 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’s Disease PBS Authority Application - Supporting Information Form which includes the following:

 
(i) (1) the completed current and baseline Crohn’s Disease Activity Index (CDAI) Score calculation sheet, where relevant, along with 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 tests in order to assess response to therapy; or

 
(3) the date of clinical assessment or assessments; and

 
(ii) the signed patient acknowledgement;

 
the patient’s assessment is no more than 1 month old at the time of application;

 
the baseline CDAI assessment, where applicable, is from immediately prior to commencing treatment with infliximab;

 
where a baseline CDAI assessment is not available the medical practitioner should telephone the Medicare Australia CEO to discuss;

 
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;

 
the assessment of the patient’s response to this course of therapy must be made within the 4 weeks prior to completion of the course and posted to the Medicare Australia CEO no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion;

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

 
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 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 relevant restriction for continuing PBS-subsidised treatment; 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 efalizumab, etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 demonstrable 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 acknowledgement;

 
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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
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 efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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; 

 
patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and 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 biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course; 

 
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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of infliximab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over who:

 
(a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with infliximab prior to 7 March 2007; and

 
(b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with infliximab; and

 
(c) have signed a patient 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 relevant restriction for continuing PBS-subsidised treatment; and

 
(d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with infliximab; and

 
where biological agent means efalizumab, etanercept or infliximab; and

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of infliximab therapy) and the most recent PASI assessment; and

 
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

 
(iii) the signed patient acknowledgement; 

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

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

 
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 treatment in total may be submitted by telephone; 

 
patients are eligible for PBS-subsidised treatment under the above criteria once only

 
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 efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 baseline value for this Treatment Cycle established prior to biological agent treatment; 

 
the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; 

 
the assessment of response is conducted following at least 12 weeks of therapy, 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 the course of treatment ceased; 

 
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above; 

 
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; 

 
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 treatment in total may be submitted by telephone

 
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 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 relevant restriction for continuing PBS-subsidised treatment; 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 efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 demonstrable 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 acknowledgement; 

 
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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
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 efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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; 

 
patients who demonstrate a response to a 12-week course of PBS-subsidised treatment with etanercept and 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 biological agent treatment of at least 12 weeks duration, immediately following cessation of the etanercept treatment course; 

 
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, a subsequent authority application for a supply sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

 
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of infliximab for continuing treatment as systemic monotherapy (other than methotrexate) by a dermatologist for adults 18 years and over:

 
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with infliximab prior to 7 March 2007; and

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

 
(c) who have signed a patient 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 relevant restriction for continuing PBS-subsidised treatment; and

 
(d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with infliximab; and

 
where biological agent means efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

 
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of infliximab therapy) and the most recent PASI assessment; and

 
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and

 
(iii) the signed patient acknowledgement; 

 
the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; 

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

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

 
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 treatment in total may be submitted by telephone; 

 
patients are eligible for PBS-subsidised treatment under the above criteria once only

 
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 inflixmab; and

 
(c) who have demonstrated an adequate response to their most recent course of treatment with inflixmab; and 

 
where biological agent means efalizumab, etanercept or infliximab; and 

 
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for 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 each of the 3 biological agents once, 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 baseline values established prior to biological agent treatment; or

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

 
the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; 

 
the assessment of response is conducted following at least 12 weeks of therapy, 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 the course of treatment ceased; 

 
patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above; 

 
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; 

 
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 treatment in total may be submitted by telephone

 
[13]                  Schedule 1, item dealing with Interferon Alfa-2a
omit all text from the column headed “Circumstances” and substitute:
 
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy)
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L)
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
[14]                  Schedule 1, item dealing with Interferon Alfa-2b
omit all text from the column headed “Circumstances” and substitute:
 
Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy)
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjuction with documented chronic hepatitis B infection
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L)
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
 
[15]                  Schedule 1, item dealing with Lamivudine
omit all text from the column headed “Circumstances” and substitute:
 
In respect of the tablet 100 mg and oral solution 5 mg per mL, 240 mL:
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy)
(2) (a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
In respect of the tablet 150 mg, tablet 300 mg and oral solution 10 mg per mL, 240 mL:
Treatment of human immunodeficiency virus infection in patients with:
(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL
[16]                  Schedule 1, after item dealing with Mycophenolic Acid
insert in the columns in the order indicated:
Natalizumab
Initial treatment, as monotherapy, by neurologists, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where:
the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; and
initial treatment is limited to a maximum of 6 infusions
Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug and who has demonstrated compliance with, and an ability to tolerate, this therapy, and where each course of continuing treatment is limited to a maximum of 3 infusions
[17]                  Schedule 1, item dealing with Pegfilgrastim
omit all text from the column headed “Circumstances” and substitute:
Pegfilgrastim
For use in a patient undergoing induction and consolidation therapy for acute myeloid leukaemia
A patient with breast cancer receiving standard dose adjuvant chemotherapy who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient receiving first-line chemotherapy for Hodgkin disease who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient receiving chemotherapy for myeloma who has had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in:
(a) acute lymphoblastic leukaemia; or
(b) breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide); or
(c) germ cell tumours; or
(d) infants and children with CNS tumours; or
(e) neuroblastoma; or
(f) non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen); or
(g) relapsed Hodgkin disease; or
(h) sarcoma
 
[18]                  Schedule 1, item dealing with Peginterferon Alfa-2a
omit all text from the column headed “Circumstances” and substitute:
 
Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2) (a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception;
(5) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L)
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using effective forms of contraception
The treatment course is limited to up to 48 weeks
Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
[19]                  Schedule 1, after item dealing with Peginterferon Alfa-2b
insert in the columns in the order indicated:
Raltegravir
Treatment, in combination with other antiretroviral agents, of 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
A patient 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 1 protease inhibitor
 
[20]                  Schedule 1, item dealing with Sevelamer
omit from the column headed “Circumstances” (twice occurring):
                   an adult
and substitute:
                   a patient
[21]                  Schedule 2, after item dealing with Cidofovir
insert in the columns in the order indicated:
Cinacalcet
Tablet 30 mg (as hydrochloride)
Tablet 60 mg (as hydrochloride)
Tablet 90 mg (as hydrochloride)
Oral
Oral
Oral
Sensipar
Sensipar
Sensipar
[22]                  Schedule 2, items dealing with Desferrioxamine
omit from the column headed “Brand” (twice occurring):
 
                   Hospira Australia Pty Ltd
and substitute:
                   Hospira Pty Limited
[23]                  Schedule 2, after item dealing with Mycophenolic Acid
insert in the columns in the order indicated:
Natalizumab
Solution concentrate for I.V. infusion 300 mg in 15 mL
Injection
Tysabri
[24]                  Schedule 2, items dealing with Octreotide
omit from the column headed “Brand” (three times occurring):
 
                   Hospira Australia Pty Ltd
and substitute:
                   Hospira Pty Limited
[25]                  Schedule 2, after item dealing with Peginterferon Alfa-2b
insert in the columns in the order indicated:
Raltegravir
Tablet 400 mg (as potassium)
Oral
Isentress