National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 8) (PB 68 of 2016) (Cth)
PB 68 of 2016
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 8)
National Health Act 1953
___________________________________________________________________________
I, Tony Wynd, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 25 July 2016
TONY WYND
Acting 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. 8).
(2)This Instrument may also be cited as PB 68 of 2016.
2 Commencement
This Instrument commences on 1 August 2016.
3 Amendments to PB 79 of 2011
Amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Amendments
Schedule 1 Part 1 entry for Carboplatin in the form ‘Solution for I.V. injection 450 mg in 45 mL’
omit:
Carboplatin Kabi PK MP D
Schedule 1 Part 1 entry for Epirubicin in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100mL’
omit:
Epirubicin Kabi PK MP D
Schedule 1 Part 1 entry for Gemcitabine in the form ‘Powder for I.V. infusion 1 g (as hydrochloride)’
omit:
Gemcitabine Kabi PK MP D
Schedule 1 Part 1 entry for Oxaliplatin in the form ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’
omit:
Oxaliplatin Kabi PK MP D
Schedule 1 Part 1 after entry for Pemetrexed in the form ‘Powder for I.V. infusion 100 mg (as disodium)’ and brand ‘Pemetrexed APOTEX’
insert:
PEMETREXED-DRLA RZ MP D
Schedule 1 Part 1 after entry for Pemetrexed in the forms ‘Powder for I.V. infusion 100 mg (as disodium)’ and ‘Powder for I.V. infusion 500 mg (as disodium)’ and brand ‘Reladdin’
insert:
Tevatrexed TB MP D
Schedule 1 Part 1 after entry for Pemetrexed in the form ‘Powder for I.V. infusion 1 g (as disodium)’ and brand ‘DBL Pemetrexed’
insert:
PEMETREXED-DRLA RZ MP D
Schedule 1 Part 1 after entry for Pemetrexed in the form ‘Powder for I.V. infusion 1 g (as disodium)’ and brand ‘Pemetrexed MYX’
insert:
Tevatrexed TB MP D
Schedule 1 Part 1 entry for Rituximab in each of the forms ‘Solution for I.V. infusion 500 mg in 50 mL’ and ‘Solution for I.V. infusion 100 mg in 10 mL’
omit from the column headed ‘Circumstances’ (all instances): C6187 substitute: C6309
[10] Schedule 1 Part 1 entry for Topotecan in the form ‘Powder for I.V. infusion 4 mg (as hydrochloride)’
omit:
Topotecan Kabi PK MP C6238 D
[11] Schedule 1 Part 1 entry for Vinorelbine in the form ‘Solution for I.V. infusion 50 mg (as tartrate) in 5 mL’
omit:
Vinorelbine Kabi PK MP D
[12] Schedule 1 Part 2 entry for Rituximab
omit from the column headed ‘Purposes’: P6187 substitute: P6309
[13] Schedule 2 entry for Ondansetron in the forms ‘I.V. injection 4 mg (as hydrochloride dehydrate) in 2 mL’ and ‘I.V. injection 8 mg (as hydrochloride dehydrate) in 4 mL’
omit:
Ondansetron Kabi
PK
EMP
C5749
1
0
[14] Schedule 2 entry for Rituximab in the form ‘Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL’
a. omit from the column headed ‘Circumstances (all instances)’: C6187 substitute: C6317
b. omit from the column headed ‘Purposes’: P6187 substitute: P6317
[15] Schedule 3 after entry for SZ:
insert:
TB Teva Pharma Australia Pty Limited 41 169 715 664
[16] Schedule 4 entry for Rituximab
omit:
C6187 P6187 Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not be eligible for stem cell transplantation if they have mantle cell lymphoma.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.Compliance with Authority Required procedures - Streamlined Authority Code 6187
substitute (in numerical order):
C6309
P6309
Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.
Compliance with Authority Required procedures - Streamlined Authority Code 6309
C6317 P6317 Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.
Compliance with Authority Required procedures - Streamlined Authority Code 6317
0
0
0