National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9) (PB 84 of 2016) (Cth)
PB 84 of 2016
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, KAREN HALL, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated 28 September 2016
Karen Hall
Acting Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
Part 1 Preliminary
1 Name of Instrument
(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9).
(2)This instrument may also be cited as PB 84 of 2016.
2 Commencement
This instrument commences on 1 October 2016.
3 Amendment
The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule – Amendments
Schedule
National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Division 1, Section 4, definition for medication for the treatment of HIV or AIDS
Substitute:
medication for the treatment of HIV or AIDS means any of the following:
(a)abacavir
(b)abacavir with lamivudine
(c)abacavir with lamivudine and zidovudine
(d)atazanavir
(e)azithromycin
(f)darunavir
(g)darunavir with cobicistat
(h)didanosine
dolutegravir
(j)dolutegravir with abacavir and lamivudine
(k)doxorubicin, pegylated liposomal
(l)efavirenz
(m)emtricitabine
(n)enfuvirtide
(o)etravirine
(p)fosamprenavir
(q)foscarnet
(r)ganciclovir
(s)indinavir
(t)lamivudine
(u)lamivudine with zidovudine
lopinavir with ritonavir
(w)maraviroc
nevirapine
(y)raltegravir
(z)rifabutin
(za) rilpivirine
(zb) ritonavir
(zc) saquinavir
(zd) stavudine
(ze) tenofovir
(zf) tenofovir with emtricitabine
(zg) tenofovir with emtricitabine efavirenz
(zh) tenofovir with emtricitabine, elvitegravir and cobicistat
(zi) tenofovir with emtricitabine and rilpivirine
(zj) valganciclovir
(zk) tipranavir
(zl) zidovudine
Schedule 1, after entry for Darunavir
Insert:
| Darunavir with cobicistat | Tablet containing darunavir 800mg with cobicistat 150 mg | Oral | Prezcobix | JC | EMP | C6377 C6413 C6428 | 60 | 5 | D |
Schedule 1, entry for Deferasirox
Omit from the column headed ‘Circumstances’ (all instances): C3828 C3829 Insert in numerical order: C6420 C6432
Schedule 1, entry for Deferiprone
Omit from the column headed ‘Circumstances’ (all instances): C1911 C1912 C3338 C3339 Insert in numerical order: C6380 C6403 C6442 C6448
Schedule 1, entry for Desferrioxamine
Omit from the column headed ‘Circumstances’ (all instances): C1085 C3340 Insert in numerical order: C6394 C6408
Schedule 1, entry for Infliximab
a)Omit from the column headed ‘Circumstances’ (all instances): C4603 C4625 C4630 C6076 C6082 C6110 Insert in numerical order: C6379 C6400 C6414 C6441 C6446 C6461
b)Omit from the column headed ‘Purposes’ (all instances): P4603 P4625 P4630 P6076 P6082 P6110
Insert in numerical order: P6379 P6400 P6414 P6441 P6446 P6461
Schedule 1, entry for Interferon alfa-2a
omit:
| Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe | Injection | Roferon-A | RO | EMP | C4993 C5003 C5036 C5042 | 30 | 5 | D |
Schedule 1, entry for Nevirapine
omit:
| Nevipin | RO | EMP | C4454 C4512 | 120 | 5 | D |
Schedule 1, entry for Octreotide in each of the forms: ‘Injection 50 micrograms (as acetate) in 1 mL’; ‘Injection 100 micrograms (as acetate) in 1mL’; ‘Injection 500 micrograms (as acetate) in 1 mL’:
Omit from the column headed ‘Circumstances’ (all instances): C2622 C2623 C3407 C3408 Insert in numerical order: C6369 C6388 C6389 C6390 C6476 C6477
Schedule 3, after entry for Darunavir
Insert:
| Darunavir with cobicistat | C6377 | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir; AND Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity. | Compliance with Authority Required procedures - Streamlined Authority Code 6377 |
| C6413 | Human immunodeficiency virus (HIV) infection Initial treatment Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures - Streamlined Authority Code 6413 | |
| C6428 | Human immunodeficiency virus (HIV) infection Continuing treatment Patient must have previously received PBS-subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures - Streamlined Authority Code 6428 |
Schedule 3, entry for Deferasirox
Omit entry for C3828 C3829
Substitute:
| C6420 | Where the patient is receiving treatment at/from a public hospital Chronic iron overload Patient must have a disorder of erythropoiesis. | Compliance with Authority Required procedures - Streamlined Authority Code 6420 |
| C6432 | Where the patient is receiving treatment at/from a private hospital Chronic iron overload Patient must have a disorder of erythropoiesis. | Compliance with Authority Required procedures |
Schedule 3, entry for Deferiprone
Omit entry for C1911 C1912 C3338 C3339
Substitute:
| C6380 | Where the patient is receiving treatment at/from a private hospital Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures |
| C6403 | Where the patient is receiving treatment at/from a public hospital Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures - Streamlined Authority Code 6403 |
| C6442 | Where the patient is receiving treatment at/from a private hospital Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures |
| C6448 | Where the patient is receiving treatment at/from a public hospital Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 6448 |
Schedule 3, entry for Desferrioxamine
Omit entry for C1085 C3340
Substitute:
| C6394 | Where the patient is receiving treatment at/from a public hospital Disorders of erythropoiesis The condition must be associated with treatment-related chronic iron overload. | Compliance with Authority Required procedures - Streamlined Authority Code 6394 |
| C6408 | Where the patient is receiving treatment at/from a private hospital Disorders of erythropoiesis The condition must be associated with treatment-related chronic iron overload. | Compliance with Authority Required procedures |
Schedule 3, entry for Infliximab
Omit entry for C4603 C4625 C4630 C6076 C6082 C6110
Substitute:
| C6379 | P6379 | Where the patient is receiving treatment at/from a private or public hospital Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND Patient must 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 Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 22 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: 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) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised. | Compliance with modified Authority Required procedures |
| C6400 | P6400 | Where the patient is receiving treatment at/from a private or public hospital Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND Patient must not receive more than 22 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats may be authorised. Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug. Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased. Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment. An adequate response to treatment is defined as: 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 or either marker reduced by at least 20% from baseline; and either of the following: (a) 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 (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). | Compliance with modified Authority Required procedures |
| C6414 | P6414 | Where the patient is receiving treatment at/from a private or public hospital Ankylosing spondylitis Continuing treatment Patient must have a documented history of active ankylosing spondylitis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be an adult. Must be treated by a rheumatologist. An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI 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; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form. All measurements provided must be no more than 1 month old at the time of application. A maximum of 24 weeks of treatment with this drug will be authorised under this criterion. At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment. Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. | Compliance with modified Authority Required procedures |
| C6441 | P6441 | Where the patient is receiving treatment at/from a private or public hospital Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. An adequate response to treatment is defined as: 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 or either marker reduced by at least 20% from baseline; and either of the following: (a) 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 (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats may be authorised. | Compliance with modified Authority Required procedures |
| C6446 | P6446 | Where the patient is receiving treatment at/from a private or public hospital Ankylosing spondylitis Initial 2 (change or recommencement for all patients) Patient must have a documented history of active ankylosing spondylitis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND Patient must be eligible to receive further bDMARD therapy. Patient must be an adult. Must be treated by a rheumatologist. Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form. A maximum of 18 weeks of treatment with this drug will be approved under this criterion. At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. | Compliance with modified Authority Required procedures |
| C6461 | P6461 | Where the patient is receiving treatment at/from a private or public hospital Active ankylosing spondylitis Initial 1 (new patients) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND Patient must have 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 Patient must have 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 3 months. Patient must be an adult. Must be treated by a rheumatologist. The application must include 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 TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; 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. The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application. Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include 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 completed Exercise Program Self Certification Form included in the supporting information form; and (iv) a signed patient acknowledgment. The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment. A maximum of 18 weeks of treatment with this drug will be approved under this criterion. At the time of authority application, the doctor should request the appropriate number of vials, based on the weight of the patient, to provide for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. | Compliance with modified Authority Required procedures |
Schedule 3, entry for Octreotide
Omit entry for C2622 C2623 C3407 C3408
Substitute:
| C6369 | Where the patient is receiving treatment at/from a public hospital Vasoactive intestinal peptide secreting tumour (VIPoma) The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 6369 |
| C6388 | Where the patient is receiving treatment at/from a private hospital Vasoactive intestinal peptide secreting tumour (VIPoma) The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures |
| C6389 | Where the patient is receiving treatment at/from a public hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures - Streamlined Authority Code 6389 |
| C6390 | Where the patient is receiving treatment at/from a public hospital Functional carcinoid tumour The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 6390 |
| C6476 | Where the patient is receiving treatment at/from a private hospital Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily. In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures |
| C6477 | Where the patient is receiving treatment at/from a private hospital Functional carcinoid tumour The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures |
Schedule 4 - Patient Contributions
Substitute:
| Listed Drug | Form (strength, type, size, etc.) | Manner of Administration | Brand | Pack Quantity | Approved Ex‑manufacturer Price or Proportional Ex‑manufacturer Price $ | Claimed price $ |
| NIL entry | ||||||
0
0
0