National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 9) (PB 78 of 2019) (Cth)
Case
PB 78 of 2019
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, 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 30 September 2019
BEN SLADIC
Assistant Secretary
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 2019 (No. 9).
(2)This Instrument may also be cited as PB 78 of 2019.
Commencement
This Instrument commences on 1 October 2019.
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
Part 1, Division 1, Section 4, definition for ‘CAR drug’
substitute:
CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:
(a) abatacept
(b) adalimumab
(c) ambristentan
(d) azacitidine
(e) benralizumab
(f) bosentan
(g) eculizumab
(h) eltrombopag
(i) epoprostenol
(j) etanercept
(k) iloprost
(l) infliximab
(m) ivacaftor
(n) lenalidomide
(o) lumacaftor with ivacaftor
(p) macitentan
(q) mepolizumab
(r) midostaurin
(s) nusinersen
(t) omalizumab
(u) pasireotide
(v) pegvisomant
(w) pomalidomide
(x) riociguat
(y) rituximab
(z) romiplostim
(aa) sildenafil
(bb) tadalafil
(cc) teduglutide
(dd) tocilizumab
(ee) ustekinumab
(ff) vedolizumab
Schedule 1, entry for Adalimumab in each of the forms: Injection 20 mg in 0.4 mL pre filled syringe; Injection 40 mg in 0.8 mL pre filled syringe; and Injection 40 mg in 0.8 mL pre filled pen
omit from the column headed “Circumstances” (all instances): C4464 C4465 C4491 C4500 C4546substitute: C9384 C9417 C9423 C9424 C9425 C9426
Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 3;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6878
(b)omit from the column headed “Circumstances”: C7743
(c)insert in numerical order in the column headed “Circumstances”: C9589 C9636
(d)omit from the column headed “Purposes”: P6878
(e)insert in numerical order in the column headed “Purposes”: P9589
Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 5;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6878
(b)omit from the column headed “Circumstances”: C7743
(c)insert in numerical order in the column headed “Circumstances”: C9589 C9636
(d)omit from the column headed “Purposes”: P7743
(e)insert in numerical order in the column headed “Purposes”: P9636
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL
(a)omit from the column headed “Circumstances”: C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL
(a)omit from the column headed “Circumstances”: C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL
(a)omit from the column headed “Circumstances”: C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Apomorphine in the form Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL
pre-filled pen
(a)omit from the column headed “Circumstances” (all instances): C4860
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9561
Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe
(a)omit from the column headed “Circumstances”: C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Azithromycin
(a)omit from the column headed “Circumstances”: C6361
(b)insert in numerical order in the column headed “Circumstances”: C9604
Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL
(a)omit from the column headed “Circumstances” (all instances): C6912
(b)omit from the column headed “Circumstances” (all instances): C6929 C6930 C6935
(c)insert in numerical order in the column headed “Circumstances” (all instances): C9488 C9489 C9524 C9637
Schedule 1, entry for Baclofen in the form Intrathecal injection 40 mg in 20 mL
(a)omit from the column headed “Circumstances”: C7156 C7157 C7159 C7162
(b)insert in numerical order in the column headed “Circumstances”: C9525 C9562 C9606 C9638
Schedule 1, entry for Clozapine in the form Tablet 25 mg
(a)omit from the column headed “Circumstances” (all instances): C5001
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9490
Schedule 1, entry for Clozapine in the form Tablet 50 mg
(a)omit from the column headed “Circumstances”: C5001
(b)insert in numerical order in the column headed “Circumstances”: C9490
Schedule 1, entry for Clozapine in the form Tablet 100 mg
(a)omit from the column headed “Circumstances” (all instances): C5001
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9490
Schedule 1, entry for Clozapine in the form Tablet 200 mg
(a)omit from the column headed “Circumstances”: C5001
(b)insert in numerical order in the column headed “Circumstances”: C9490
Schedule 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL
(a)omit from the column headed “Circumstances” (all instances): C5001
(b)insert in numerical order in the column headed “Circumstances” (all instances): C9490
Schedule 1, entry for Deferiprone in the form Tablet 1000 mg
(a)omit from the column headed “Circumstances”: C6380
(b)omit from the column headed “Circumstances”: C6442
(c)insert in numerical order in the column headed “Circumstances”: C9590 C9623
Schedule 1, entry for Dornase Alfa
(a)omit from the column headed “Circumstances”: C5715
(b)omit from the column headed “Circumstances”: C5768 C5800
(c)insert in numerical order in the column headed “Circumstances”: C9591 C9592 C9624
Schedule 1, entry for Etanercept in all forms
omit from the column headed “Circumstances” (all instances): C4459 C4461 C4486 C4487 C4540substitute (all instances): C9384 C9416 C9417 C9418 C9532 C9565
Schedule 1, entry for Filgrastim
substitute:
| Filgrastim | Injection 120 micrograms in 0.2 mL single-use pre-filled syringe | Injection | Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D |
| Injection 300 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |
| Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |||
| Zarzio | SZ | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |||
| Injection 300 micrograms in 1 mL | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |
| Injection 480 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |
| Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |||
| Zarzio | SZ | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D | |||
| Injection 480 micrograms in 1.6 mL | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | D |
Schedule 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium)
(a)omit from the column headed “Circumstances” (all instances): C4990
(b)omit from the column headed “Circumstances” (all instances): C5025
(c)insert in numerical order in the column headed “Circumstances” (all instances): C9404 C9526
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Inflectra]
(a)omit from the column headed “Circumstances”: C4535
(b)omit from the column headed “Circumstances”: C7711
(c)omit from the column headed “Circumstances”: C7774
(d)omit from the column headed “Circumstances”: C7887
(e)omit from the column headed “Circumstances”: C8011 C8044 C8070 C8080 C8102 C8109 C8117 C8129
(f)omit from the column headed “Circumstances”: C8763 C8796
(g)insert in numerical order in the column headed “Circumstances”: C8931
(h)omit from the column headed “Circumstances”: C8959
(i)omit from the column headed “Circumstances”: C9154
(j)insert in numerical order in the column headed “Circumstances”: C9397 C9400 C9401 C9402 C9472 C9481 C9487 C9499 C9552 C9557 C9558 C9559 C9584 C9602 C9615 C9621 C9632
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remicade]
(a)omit from the column headed “Circumstances”: C4535
(b)omit from the column headed “Circumstances”: C8011 C8044 C8070 C8071 C8080 C8102 C8129
(c)insert in numerical order in the column headed “Circumstances”: C9400 C9401 C9402 C9487 C9558 C9559 C9587 C9632
Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Renflexis]
(a)omit from the column headed “Circumstances”: C4535
(b)omit from the column headed “Circumstances”: C7711
(c)omit from the column headed “Circumstances”: C7774
(d)omit from the column headed “Circumstances”: C7887
(e)omit from the column headed “Circumstances”: C8011 C8044 C8070 C8080 C8102 C8109 C8117 C8129
(f)omit from the column headed “Circumstances”: C8763 C8796
(g)insert in numerical order in the column headed “Circumstances”: C8931
(h)omit from the column headed “Circumstances”: C8959
(i)omit from the column headed “Circumstances”: C9154
(j)insert in numerical order in the column headed “Circumstances”: C9397 C9400 C9401 C9402 C9472 C9481 C9487 C9499 C9552 C9557 C9558 C9559 C9584 C9602 C9615 C9621 C9632
Schedule 1, entry for Interferon Gamma-1b
(a)omit from the column headed “Circumstances”: C6286
(b)insert in numerical order in the column headed “Circumstances”: C9639
Schedule 1, entry for Levodopa with Carbidopa
(a)omit from the column headed “Circumstances”: C6880
(b)insert in numerical order in the column headed “Circumstances”: C9405
Schedule 1, entry for Mannitol
(a)omit from the column headed “Circumstances”: C7349
(b)omit from the column headed “Circumstances”: C7364
(c)insert in numerical order in the column headed “Circumstances”: C9527 C9593
Schedule 1, entry for Natalizumab
(a)omit from the column headed “Circumstances”: C6845
(b)omit from the column headed “Circumstances”: C7769
(c)insert in numerical order in the column headed “Circumstances”: C9406
Schedule 1, entry for Ocrelizumab
(a)omit from the column headed “Circumstances”: C7412
(b)omit from the column headed “Circumstances”: C7771
(c)insert in numerical order in the column headed “Circumstances”: C9523 C9635
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”: C5016
(b)insert in numerical order in the column headed “Circumstances”: C9603
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”: C5016
(b)insert in numerical order in the column headed “Circumstances”: C9603
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”: C5016
(b)insert in numerical order in the column headed “Circumstances”: C9603
(c)omit from the column headed “Purposes”: P5016
(d)insert in numerical order in the column headed “Purposes”: P9603
Schedule 1, entry for Rifabutin
(a)omit from the column headed “Circumstances”: C6349
(b)omit from the column headed “Circumstances”: C6361
(c)insert in numerical order in the column headed “Circumstances”: C9560 C9622
Schedule 1, entry for Rituximab
substitute:
| Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | Mabthera | RO | EMP | C7021 C7022 C9344 C9511 | See Note 1 | See Note 2 | PB |
| Riximyo | SZ | EMP | C7021 C7022 C9336 C9344 C9511 C9539 C9640 C9641 | See Note 1 | See Note 2 | PB | |||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | Mabthera | RO | EMP | C7021 C7022 C9340 C9344 C9448 C9449 C9450 C9511 C9512 | See Note 1 | See Note 2 | PB | |
| Riximyo | SZ | EMP | C7021 C7022 C9336 C9340 C9344 C9446 C9448 C9449 C9450 C9511 C9512 C9539 C9611 C9640 C9641 | See Note 1 | See Note 2 | PB |
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)
omit:
| Prograf XL | LL | EMP | C5569 C5602 | 60 | 5 | C |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)
omit:
| Prograf XL | LL | EMP | C5569 C5602 | 120 | 5 | C |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)
omit:
| Prograf XL | LL | EMP | C5569 C5602 | 60 | 5 | C |
Schedule 1, after entry for Tadalafil
insert:
| Teduglutide | Powder for injection 5 mg with diluent | Injection | Revestive | ZI | EMP | C9456 C9457 C9458 C9515 C9543 C9569 | See Note 1 | See Note 2 | D |
Schedule 1, entry for Tocilizumab in each of the forms: Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL
(a)omit from the column headed “Circumstances”: C4453 C4466 C4493 C4497 C4502 C4508 C4515 C4521 C4541 C4542 C5977 C6019 C6020 C6041 C6053
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9384 C9386 C9394 C9395 C9407 C9417 C9434 C9435 C9437 C9438 C9439 C9483 C9484 C9494 C9495 C9496 C9507
Schedule 1, entry for Zoledronic acid
omit:
| Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial | Injection | Claris Lifesciences Zoledronic Acid | DZ | EMP | C5605 C5703 C5704 C5735 C9236 C9269 C9270 C9291 | 5 | 0 | PB |
Schedule 3, entry for Abatacept
(a)omit entry for circumstances code “C8655” and substitute:
| C8655 | Severe active rheumatoid arthritis 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 received this drug as their most recent course of PBS-subsidised biological medicine treatment 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(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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 Written Authority Required procedures |
(b)omit entry for circumstances code “C8688” and substitute:
| C8688 | Severe active rheumatoid arthritis Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine 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 have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 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. Major joints are defined as (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). All measures of joint count and ESR and/or CRP 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. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal 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. | Compliance with Written Authority Required procedures |
(c)omit entry for circumstances code “C8748” and substitute:
| C8748 | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine 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; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 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). 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, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. 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. Up to a maximum of 4 repeats will be authorised. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. 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. | Compliance with Written Authority Required procedures |
(d)omit entry for circumstances code “C8759” and substitute:
| C8759 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) 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; 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 16 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. 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 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. Up to a maximum of 4 repeats will be authorised. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal 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. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Adalimumab
substitute:
| C9384 | Severe active juvenile idiopathic arthritis Continuing treatment - balance of supply Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received insufficient therapy with this drug for this condition 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. | Compliance with Authority Required procedures |
| C9417 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9423 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. An adequate response to treatment is defined as: (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, cervical spine 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). At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9424 | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment 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 per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as: (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, cervical spine 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). Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 5 repeats will be authorised. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9425 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. Active joints are defined as: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine 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). All measures of joint count must be no more than 4 weeks old at the time of this application. 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 active joints, the response must be demonstrated on the total number of active joints. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9426 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: (a) an active joint count of at least 20 active (swollen and tender) joints; OR (b) at least 4 active joints from the following list: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine 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 assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Alemtuzumab
(a)omit:
| C6878 | P6878 | Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must not receive more than one PBS-subsidised treatment per year; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist. | Compliance with Authority Required procedures |
(b)omit:
| C7743 | P7743 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C9589 | P9589 | Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must not receive more than one PBS-subsidised treatment per year; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist. | Compliance with Authority Required procedures - Streamlined Authority Code 9589 |
| C9636 | P9636 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 9636 |
Schedule 3, entry for Apomorphine
(a)omit:
| C4860 | Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9561 | Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9561 |
Schedule 3, entry for Azithromycin
(a)omit:
| C6361 | Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9604 | Mycobacterium avium complex infection The treatment must be for prophylaxis; AND Patient must be human immunodeficiency virus (HIV) positive; AND Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures - Streamlined Authority Code 9604 |
Schedule 3, entry for Baclofen
(a)omit:
| C6912 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures |
(b)omit:
| C6929 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures |
| C6930 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures |
| C6935 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures |
(c)omit:
| C7156 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures |
| C7157 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures |
| C7159 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures |
| C7162 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures |
(d)insert in numerical order after existing text:
| C9488 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures - Streamlined Authority Code 9488 |
| C9489 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures - Streamlined Authority Code 9489 |
| C9524 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures - Streamlined Authority Code 9524 |
| C9525 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures - Streamlined Authority Code 9525 |
| C9562 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures - Streamlined Authority Code 9562 |
| C9606 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures - Streamlined Authority Code 9606 |
| C9637 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures - Streamlined Authority Code 9637 |
| C9638 | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures - Streamlined Authority Code 9638 |
Schedule 3, entry for Clozapine
(a)omit:
| C5001 | Schizophrenia Initial treatment Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient. Patient must be non-responsive to other neuroleptic agents; OR Patient must be intolerant of other neuroleptic agents. Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction. The name of the consulting psychiatrist should be included in the patient's medical records. A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C9490 | Schizophrenia Initial treatment Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient. Patient must be non-responsive to other neuroleptic agents; OR Patient must be intolerant of other neuroleptic agents. Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction. The name of the consulting psychiatrist should be included in the patient's medical records. A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures - Streamlined Authority Code 9490 |
Schedule 3, entry for Deferiprone
(a)omit:
| C6380 | Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures |
(b)omit:
| C6442 | Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C9590 | Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures - Streamlined Authority Code 9590 |
| C9623 | Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9623 |
Schedule 3, entry for Dornase alfa
(a)omit:
| C5715 | Cystic fibrosis Continuing treatment Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Patient must be 5 years of age or older. Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures |
(b)omit:
| C5768 | Cystic fibrosis Patient must be 5 years of age or older. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures |
| C5800 | Cystic fibrosis Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy. Patient must be less than 5 years of age. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C9591 | Cystic fibrosis Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy. Patient must be less than 5 years of age. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals. | Compliance with Authority Required procedures - Streamlined Authority Code 9591 |
| C9592 | Cystic fibrosis Continuing treatment Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Patient must be 5 years of age or older. Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 9592 |
| C9624 | Cystic fibrosis Patient must be 5 years of age or older. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily. To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures - Streamlined Authority Code 9624 |
Schedule 3, entry for Etanercept
substitute:
| C9384 | Severe active juvenile idiopathic arthritis Continuing treatment - balance of supply Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received insufficient therapy with this drug for this condition 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. | Compliance with Authority Required procedures |
| C9416 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: (a) an active joint count of at least 20 active (swollen and tender) joints; OR (b) at least 4 active joints from the following list: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine 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 assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9417 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9418 | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment 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 per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as: (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, cervical spine 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). Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9532 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. Active joints are defined as: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine 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). All measures of joint count must be no more than 4 weeks old at the time of this application. 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 active joints, the response must be demonstrated on the total number of active joints. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9565 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. An adequate response to treatment is defined as: (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, cervical spine 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). At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Ganciclovir
(a)omit:
| C4990 | Cytomegalovirus disease Prophylaxis Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures |
(b)omit:
| C5025 | Cytomegalovirus disease Prophylaxis Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C9404 | Cytomegalovirus disease Prophylaxis Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 9404 |
| C9526 | Cytomegalovirus disease Prophylaxis Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 9526 |
Schedule 3, entry for Infliximab
(a)omit:
| C4535 | Acute severe ulcerative colitis Must be treated by a gastroenterologist; OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]. Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital. Patient must be 6 years of age or older. For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where: (i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L (ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood. For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours. At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records. Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records. | Compliance with Authority Required procedures |
(b)omit:
| C7711 | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. 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 have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be aged 18 years or older. 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. Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response. 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 eight weekly. Up to a maximum of 2 repeats will be authorised. 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 |
(c)omit:
| C7774 | Complex refractory Fistulising Crohn disease Subsequent 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. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. 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. Patients are eligible to receive subsequent continuing 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. 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, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
(d)omit:
| C7887 | Moderate to severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician or a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First Continuing treatment restriction; AND Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND Patient must have a total PCDAI score of 30 points or less. Patient must be aged 6 to 17 years inclusive. The PCDAI assessment must be no more than 1 month old at the time of application. 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. 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 eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
(e)omit:
| C8011 | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are only eligible to receive 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. 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 eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Authority Required procedures |
| 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 |
| 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 |
| 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 |
| 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 |
| C9439 | Systemic juvenile idiopathic arthritis Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as: (a) in a patient with polyarticular course disease: (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%: - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine 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). (b) in a patient with refractory systemic symptoms: (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9483 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. An adequate response to treatment is defined as: (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, cervical spine 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). At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9484 | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment 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 per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as: (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, cervical spine 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). Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9494 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine 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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. 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) an active joint count of fewer than 10 active (swollen and tender) joints; or (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (c) 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, cervical spine 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). At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9495 | Severe active juvenile idiopathic arthritis 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 received this drug as their most recent course of PBS-subsidised biological medicine treatment 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 per continuing treatment course authorised under this restriction. 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) an active joint count of fewer than 10 active (swollen and tender) joints; or (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (c) 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, cervical spine 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) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9496 | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) 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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; 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 16 weeks of treatment under this restriction. 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 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. 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 and dose for each DMARD must be provided in the authority application. 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) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine 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. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9507 | Systemic juvenile idiopathic arthritis 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; AND Patient must not receive more than 24 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as: (a) in a patient with polyarticular course disease: (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%: - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine 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). (b) in a patient with refractory systemic symptoms: (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity submitted with the initial treatment application. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes baseline and current pathology reports detailing CRP and platelet count where appropriate. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application. At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Zoledronic Acid
(a)omit:
| C9236 | Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9236 |
(b)omit:
| C9269 | Multiple myeloma | Compliance with Authority Required procedures - Streamlined Authority Code 9269 |
| C9270 | Bone metastases The condition must be due to breast cancer. | Compliance with Authority Required procedures - Streamlined Authority Code 9270 |
| C9291 | Bone metastases The condition must be due to castration-resistant prostate cancer. | Compliance with Authority Required procedures - Streamlined Authority Code 9291 |
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