National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 9) (PB 94 of 2018) (Cth)
PB 94 of 2018
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, NATASHA PLOENGES, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 26 October 2018
NATASHA PLOENGES
Assistant Secretary (Acting)
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 9).
(2)This Instrument may also be cited as PB 94 of 2018.
Commencement
This Instrument commences on 1 November 2018.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Schedule 1, after entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL
insert:
| Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Movapo Pen | TD | EMP | C4833 C4860 | 100 | 5 | D |
Schedule 1, entry for Infliximab
(a)for the brand “Inflectra”, omit from the column headed “Circumstances”: C4626 C4627 C4705 C4718
(b)for the brand “Inflectra”, omit from the column headed “Circumstances”: C5440 C5484 C5485
(c)for the brand “Inflectra”, omit from the column headed “Circumstances”: C6414
(d)for the brand “Inflectra”, omit from the column headed “Circumstances”: C6446 C6461
(e)for the brand “Inflectra”, insert in numerical order in the column headed "Circumstances": C8044 C8046 C8047 C8049 C8068 C8070 C8080 C8082 C8089 C8102 C8109 C8112 C8117 C8129
(f)for the brand “Remicade”, omit from the column headed “Circumstances”: C4626 C4627 C4705 C4718
(g)for the brand “Remicade”, omit from the column headed “Circumstances”: C5440 C5484 C5485
(h)for the brand “Remicade”, omit from the column headed “Circumstances”: C6414
(i)for the brand “Remicade”, omit from the column headed “Circumstances”: C6446 C6461
(j)for the brand “Remicade”, insert in numerical order in the column headed "Circumstances": C8044 C8046 C8047 C8067 C8068 C8070 C8071 C8080 C8082 C8089 C8102 C8129
(k)for the brand “Renflexis”, omit from the column headed “Circumstances”: C4626 C4627 C4705 C4718
(l)for the brand “Renflexis”, omit from the column headed “Circumstances”: C5440 C5484 C5485
(m)for the brand “Renflexis”, omit from the column headed “Circumstances”: C6414
(n)for the brand “Renflexis”, omit from the column headed “Circumstances”: C6446 C6461
(o)for the brand “Renflexis”, insert in numerical order in the column headed "Circumstances": C8044 C8046 C8047 C8049 C8068 C8070 C8080 C8082 C8089 C8102 C8109 C8112 C8117 C8129
Schedule 1, entry for Nusinersen
substitute:
| Nusinersen | Solution for injection 12 mg in 5 mL | Injection | Spinraza | BD | EMP | C7848 C7849 C7870 | See Note 1 | See Note 2 | D |
Schedule 1, entry for Pegfilgrastim
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Tezmota | JX | EMP | C7822 C7823 C7843 C7862 | 1 | 11 | D |
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre filled syringe
(a)omit from the column headed “Circumstances”: C5010
(b)omit from the column headed “Circumstances”: C5067
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre filled syringe [Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C5010
(b)omit from the column headed “Circumstances”: C5067
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre filled syringe [Maximum Quantity: 8; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C5010
(b)omit from the column headed “Circumstances”: C5067
(c)omit from the column headed “Purposes”: P5010
(d)omit from the column headed “Purposes”: P5067
Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zoledronic Acid 4 mg/100 mL APOTEX | TX | EMP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | PB |
Schedule 2, after details relevant to Responsible Person code JU
insert:
| JX | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
Schedule 3, entry for Adalimumab
(a)for circumstances codes C4464 and C4465, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(b)for circumstances codes C4491 and C4500, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(c)for circumstances code C4546, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Ambrisentan
(a)for circumstances code C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6711, C6722 and C6734, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances code C6765, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Anakinra
omit code from the column headed "Purposes Code"
Schedule 3, entry for Atazanavir with cobicistat
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Azacitidine
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Bosentan
(a)for circumstances codes C4628 and C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6710 and C6734, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances codes C6764 and C6776, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Clarithromycin
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Darunavir
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Dolutegravir with abacavir and lamivudine
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Eculizumab
for all circumstances codes, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Epoprostenol
(a)for circumstances code C6123, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances code C6734, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Etanercept
(a)for circumstances code C4459, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C4461 and C4486, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C4487, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Everolimus
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Fosamprenavir
omit:
| C4980 | Cytomegalovirus retinitis Clinical criteria: Patient must have HIV infection. | Compliance with Authority Required procedures - Streamlined Authority Code 4980 |
Schedule 3, entry for Ibandronic acid
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Iloprost
(a)for circumstances code C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6692, C6734 and C6747, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances code C6775, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Infliximab
(a)omit:
| C4626 | Ankylosing spondylitis Treatment Phase: Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply Clinical criteria: Patient must have active, or a documented history of active, ankylosing spondylitis; AND Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 18 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 18 weeks treatment; AND The treatment must provide no more than the balance of up to 18 weeks treatment available under the above restrictions. Population criteria: Patient must be an adult. Treatment criteria: Must be treated by a rheumatologist. | Compliance with modified Authority Required procedures |
| C4627 | Ankylosing spondylitis Treatment Phase: Continuing treatment – balance of supply Clinical criteria: Patient must have a documented history of active ankylosing spondylitis; AND Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Population criteria: Patient must be an adult. Treatment criteria: Must be treated by a rheumatologist. | Compliance with modified Authority Required procedures |
| C4705 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply. Patient must have received insufficient infliximab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 22 weeks treatment; OR Patient must have received insufficient infliximab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 22 weeks treatment; AND The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. | Compliance with modified Authority Required procedures |
| C4718 | Severe active rheumatoid arthritis Continuing Treatment – balance of supply. Patient must have received insufficient infliximab therapy under the Continuing Treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. | Compliance with modified Authority Required procedures |
(b)for circumstances codes C4846 and C4854, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(c)omit:
| C5440 | Severe active rheumatoid arthritis Treatment Phase: Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis, AND Patient must have demonstrated an adequate response to treatment with infliximab, AND Patient must have received infliximab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment, AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction, AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats will be authorised. All applications for continuing treatment with infliximab 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 with infliximab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab. If a patient fails to demonstrate a response to treatment with infliximab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with modified Authority Required procedures |
| C5484 | Severe active rheumatoid arthritis Treatment Phase: Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis, AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months, AND Patient must have not failed previous PBS-subsidised treatment with infliximab for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times, AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly, AND Patient must not receive more than 22 weeks of treatment under this restriction, AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application including severity. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab. Applications for a patient who has received PBS-subsidised treatment with infliximab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised infliximab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised infliximab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with infliximab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following 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) a total 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). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response. | Compliance with modified Authority Required procedures |
| C5485 | Severe active rheumatoid arthritis Treatment Phase: Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months). Patient must have a documented history of severe active rheumatoid arthritis, AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy, AND Patient must not receive more than 22 weeks of treatment under this restriction, AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised. Applications for a patient who has received PBS-subsidised treatment with infliximab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised infliximab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised infliximab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab. If a patient fails to demonstrate a response to a treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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 |
(d)for circumstances codes C6379 and C6400, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(e)omit:
| C6414 | 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 |
(f)for circumstances code C6441, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(g)omit:
| C6446 | 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 | 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 |
(h)for circumstances codes C6712, C6729, C6741, C6757 and C6767, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(i)for circumstances codes C6768 and C6780, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(j)for circumstances code C6791, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(k)insert in numerical order after existing text:
| C8044 | Ankylosing spondylitis Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years). Patient must have received prior PBS-subsidised treatment with a biological medicine 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. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either of the initial treatment restrictions the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. This assessment must be submitted 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. A patient who fails 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. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. 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 for infusions at a dose of 5 mg per kg. A maximum of 18 weeks of treatment with this drug will be approved under this criterion. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8046 | Severe active rheumatoid arthritis Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and must have not already failed, or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 22 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application including severity. The authority application must be made in writing and must include: (1)a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1 or Initial 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing or subsequent continuing treatment restriction, the patient must have been assessed for response. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following 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) a total 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). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8047 | Severe active rheumatoid arthritis Continuing Treatment – balance of supply. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
| C8049 | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
| C8067 | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1)a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats will be authorised. A patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction. | Compliance with Written Authority Required procedures |
| C8068 | Severe active rheumatoid arthritis Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 22 weeks treatment; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 22 weeks treatment; AND The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions. Patient must be aged 18 years or older. | Compliance with Authority Required procedures |
| C8070 | Ankylosing spondylitis First continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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. 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 used to determine response for all subsequent continuing treatments. All measurements provided must be no more than 1 month old at the time of application. 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 for infusions at a dose of 5 mg per kg. The application for first continuing treatment following an initial treatment course must be made following a minimum of 12 weeks of treatment with this drug. This assessment must be 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 patient who fails 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. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. A maximum of 24 weeks of treatment with this drug will be authorised under this criterion. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8071 | Ankylosing spondylitis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be aged 18 years or older. 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. 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 used to determine response for all subsequent continuing treatments. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. 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 for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8080 | Ankylosing spondylitis Balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 treatment (New patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 18 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or recommencement of treatment after a break in therapy of less than 5 years) restriction to complete 18 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks treatment. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C8082 | Severe active rheumatoid arthritis Initial 2 (change or re-commencement of treatment after a break of less than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not receive more than 22 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1)a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1 or Initial 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be conducted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken the patient will be deemed to have failed to respond to treatment with this drug. Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing or subsequent continuing treatment restriction, the patient must have been assessed for response. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8089 | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1)a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. The application for first continuing treatment following an initial treatment course must be made following a minimum of 12 weeks of treatment with this drug. This assessment must be 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. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats will be authorised. |
| C8102 | Ankylosing spondylitis Initial 2 - Change or Re-commencement of treatment after a break in therapy of less than 5 years Patient must have received prior PBS-subsidised treatment with a biological medicine 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. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either of the initial treatment restrictions the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. This assessment must be submitted 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. A patient who fails 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. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. 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 for infusions at a dose of 5 mg per kg. A maximum of 18 weeks of treatment with this drug will be approved under this criterion. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C8109 | Ankylosing spondylitis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be aged 18 years or older. 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 used to determine response for all subsequent continuing treatments. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. A patient who fails 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. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 8109 |
| C8112 | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND 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 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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8112 |
| C8117 | Ankylosing spondylitis Subsequent continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug. Patient must be aged 18 years or older. 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 used to determine response for all subsequent continuing treatments. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. 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 for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. | Compliance with Authority Required procedures |
| C8129 | Ankylosing spondylitis Initial 1 (New patient or recommencement of treatment after more than 5 years break in therapy) 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 for this condition with a biological medicine 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 aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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 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 completed Exercise Program Self Certification Form included in the supporting information form. 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 patient who fails 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. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle. 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 for infusions at a dose of 5 mg per kg. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. A maximum of 18 weeks of treatment with this drug will be approved under this criterion. Up to a maximum of 3 repeats will be authorised. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Lanthanum
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Lenalidomide
for circumstances codes C4282 and C4287, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Macitentan
(a)for circumstances code C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6693, C6722, C6734 and C6735, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Mepolizumab
for circumstances code C6635, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Mycophenolic Acid
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Nusinersen
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Omalizumab
for circumstances codes C6563, C6603, C6627 and C6689, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir
omit code from the column headed “Purposes Code”
Schedule 3, entry for Pasireotide
for circumstances code C6330, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Peginterferon alfa-2a
(a)omit:
| C5010 | P5010 | Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must not have previously received peginterferon alfa therapy for the treatment of hepatitis B, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy, AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 5010 |
(b)omit:
| C5067 | P5067 | Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have detectable HBV DNA, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND The treatment must be limited to 1 course of treatment for a maximum duration of 48 weeks. Patients 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. | Compliance with Authority Required procedures - Streamlined Authority Code 5067 |
Schedule 3, entry for Pegvisomant
for circumstances code C7087, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with Written Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Riociguat
(a)for circumstances codes C6645, C6664 and C6690, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(b)for circumstances code C6691, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(c)for circumstances code C6708, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(d)for circumstances code C6720, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(e)for circumstances code C6733, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(f)for circumstances code C6760, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Rituximab
(a)omit all codes from the column headed “Purposes Code”
(b)for circumstances codes C6015, C6042 and C6049, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Sevelamer
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Sildenafil
(a)for circumstances code C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6723, C6734 and C6736, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances code C6749, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Sirolimus
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Sucroferric oxyhydroxide
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Tacrolimus
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Tadalafil
(a)for circumstances code C6089, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C6709, C6721 and C6734, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6748, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances code C6761, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Tipranavir
omit code from the column headed “Purposes Code”
Schedule 3, entry for Tocilizumab
(a)omit all codes from the column headed “Purposes Code”
(b)for circumstances code C4453, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(c)for circumstances codes C4466 and C4493, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(d)for circumstances codes C4497 and C4502, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(e)for circumstances codes C4508, C4515, C4521 and C4541, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(f)for circumstances codes C4542, C4672 and C4673, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(g)for circumstances code C5976, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(h)for circumstances code C5977, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(i)for circumstances code C5979, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(j)for circumstances code C6019, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(k)for circumstances codes C6020, C6041, C6050 and C6053, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Valaciclovir
omit all codes from the column headed “Purposes Code”
Schedule 3, entry for Vedolizumab
(a)for circumstances code C5104, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(b)for circumstances codes C5121 and C5127 , omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for circumstances code C6612, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for circumstances code C7146, omit from the column headed “Authority Requirements - Part of Circumstances”:
Compliance with Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
Schedule 3, entry for Zoledronic acid
omit all codes from the column headed “Purposes Code”
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0
0