National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 12) (PB 114 of 2016) (Cth)
PB 114 of 2016
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 12)
National Health Act 1953
I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Dated 21 DECEMBER 2016
JULIANNE QUAINE
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 12).
(2) This Instrument may also be cited as PB 114 of 2016.
2 Commencement
This Instrument commences on 1 January 2017.
3Amendment of PB 79 of 2011
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1 Amendments
1 Schedule 1, Part 1 (table item dealing with Bleomycin, column headed ‘Responsible Person’)
omit: HH substitute: PF
2 Schedule 1, Part 1 (table item dealing with Carboplatin, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
3 Schedule 1, Part 1 (table item dealing with Cisplatin, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
4 Schedule 1, Part 1 (table item dealing with Docetaxel, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
5 Schedule 1, Part 1 (table item dealing with Doxorubicin, after the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial, manner of administration Injection/intravesical and brand Accord Doxorubicin)
insert: Doxorubicin ACC OC MP D
6 Schedule 1, Part 1 (table item dealing with Doxorubicin, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
7 Schedule 1, Part 1 (table item dealing with Epirubicin, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
8 Schedule 1, Part 1 (table item dealing with Fluorouracil, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
9 Schedule 1, Part 1 (table item dealing with Gemcitabine, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
10 Schedule 1, Part 1 (table item dealing with Ipilimumab, column headed ‘Circumstances’)
omit (all instances): C4251
C4252
11 Schedule 1, Part 1 (table item dealing with Irinotecan, after the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL, manner of administration Injection and brand Hospira Pty Ltd)
insert: Irinotecan Accord OC MP D
12 Schedule 1, Part 1 (table item dealing with Irinotecan, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
13 Schedule 1, Part 1 (table item dealing with Methotrexate, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
14 Schedule 1, Part 1 (table item dealing with Mitozantrone, column headed ‘Responsible Person’)
omit : HH substitute: PF
15 Schedule 1, Part 1 (table item dealing with Oxaliplatin, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
16 Schedule 1, Part 1 (table item dealing with Paclitaxel, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
17 Schedule 1, Part 1 (table item dealing with Pemetrexed)
substitute: Pemetrexed Powder for I.V. infusion 100 mg (as disodium) Injection Alimta LY MP C4789
C4792
D DBL Pemetrexed PF MP C4789
C4792
D Pemetrexed APOTEX TX MP C4789
C4792
D PEMETREXED-DRLA RZ MP D Pemetrexed Juno JU MP C4789
C4792
D Pemetrexed MYX OC MP C4789
C4792
D Reladdin AF MP C4789
C4792
D Tevatrexed TB MP D Powder for I.V. infusion 500 mg (as disodium) Injection Alimta LY MP C4789
C4792
D DBL Pemetrexed PF MP C4789
C4792
D Pemetrexed APOTEX TX MP C4789
C4792
D Pemetrexed DRLA RZ MP C4789
C4792
D Pemetrexed Juno JU MP C4789
C4792
D Pemetrexed MYX OC MP C4789
C4792
D Pemetrexed Sandoz SZ MP C4789
C4792
D Reladdin AF MP C4789
C4792
D Tevatrexed TB MP D Powder for I.V. infusion 1 g (as disodium) Injection DBL Pemetrexed PF MP C4789
C4792
D PEMETREXED-DRLA RZ MP D Pemetrexed MYX YN MP C4789
C4792
D Tevatrexed TB MP D
18 Schedule 1, Part 1 (table item dealing with Raltitrexed, column headed ‘Responsible Person’)
omit: HH substitute: PF
19 Schedule 1, Part 1 (table item dealing with Vinblastine, column headed ‘Responsible Person’)
omit: HH substitute: PF
20 Schedule 1, Part 1 (table item dealing with Vincristine, column headed ‘Responsible Person’)
omit: HH substitute: PF
21 Schedule 1, Part 1 (table item dealing with Vinorelbine, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
22 Schedule 1, Part 2 (table item dealing with Ipilimumab, column headed ‘Purposes’)
omit: P4251
P4252
23 Schedule 2 (table item dealing with Folinic acid, column headed ‘Responsible Person’)
omit (all instances): HH substitute: PF
24 Schedule 2 (table item dealing with Interferon Alfa-2a)
substitute: Interferon Alfa-2a Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO EMP C6661
C6662
C6678
P6662
P6678
15 4 C C6661
C6662
C6678
P6661 15 5 C Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO EMP C6661
C6678
P6678 5 4 C C6661
C6678
P6661 5 5 Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO EMP C6661
C6678
P6678 5 4 C C6661 P6661 5 5 C C6678
25 Schedule 2 (table item dealing with Interferon Alfa-2b)
substitute: Interferon Alfa-2b Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK EMP C6639
C6661
C6662
P6662 3 4 C C6639
C6661
C6662
P6639
P6661
3 5 C Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK EMP C6639
C6661
3 5 C
26 Schedule 3, entry for code HH
omit:
HH Hospira Pty Limited 13 107 058 328
27 Schedule 4 (table item dealing with Interferon Alfa-2a)
substitute:
C6661 P6661 Low grade non-Hodgkin's lymphoma
The condition must have clinical features suggestive of a poor prognosis; AND
The treatment must be in combination with anthracycline-based chemotherapy.
Compliance with Authority Required procedures - Streamlined Authority Code 6661 C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662 C6678 P6678 Myeloproliferative disease
Patient must have excessive thrombocytosis.
Compliance with Authority Required procedures – Streamlined Authority Code 6678
28 Schedule 4 (table item dealing with Interferon Alfa-2b)
substitute:
C6639 P6639 Multiple myeloma
Maintenance treatment
The condition must be in remission following chemotherapy.
Compliance with Authority Required procedures - Streamlined Authority Code 6639 C6661 P6661 Low grade non-Hodgkin's lymphoma
The condition must have clinical features suggestive of a poor prognosis; AND
The treatment must be in combination with anthracycline-based chemotherapy.
Compliance with Authority Required procedures - Streamlined Authority Code 6661 C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662
29 Schedule 4 (table item dealing with Ipilimumab)
omit: C4251 P4251 Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of induction treatment. Treatment must be as monotherapy, and must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013. Treatment must not exceed a total of 4 doses (combined PBS‑subsidised and non‑PBS‑subsidised) at a maximum dose of 3 mg per kg every 3 weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS subsidised). Compliance with Authority Required procedures ‑ Streamlined Authority Code 4251
C4252 P4252 Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of re‑induction treatment. Treatment must be as monotherapy. Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction) received prior to 1 August 2013. Treatment must be for completion of re‑induction treatment in a patient who commenced re‑induction treatment with ipilimumab prior to 1 August 2013, and must not exceed a total of 4 doses (combined PBS‑subsidised and non‑PBS‑subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response.
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated. For patients who commenced re‑induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS‑subsidised and non‑PBS‑subsidised).Compliance with Authority Required procedures ‑ Streamlined Authority Code 4252
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