National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 8) (PB 84 of 2015) (Cth)
PB 84 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 8)
National Health Act 1953
___________________________________________________________________________
I, Steve Dunlop, 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 28 August 2015
STEVE DUNLOP
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 2015 (No. 8).
(2)This Instrument may also be cited as PB 84 of 2015.
2 Commencement
This Instrument commences on 1 September 2015.
3 Amendments to PB 79 of 2011
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1 Amendments
Schedule 1, Part 1 after the entry for Panitumumuab:
insert:
Pembrolizumab Powder for injection 50 mg Injection Keytruda MK MP C5293
C5334
C5361
C5362
D
Schedule 1, Part 2 after the entry for Panitumumab:
insert:
Pembrolizumab P5293
P5334
P5361
240 5 P5362 240 7
Schedule 4, after entry for Palonosetron:
insert:
Pembrolizumab C5293 P5293 Unresectable Stage III or Stage IV malignant melanoma
Grandfathering treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be for continuing therapy in a patient who commenced treatment with pembrolizumab prior to 1 September 2015; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.Compliance with Authority Required procedures - Streamlined Authority Code 5293
C5334 P5334 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must be negative for a BRAF V600 mutation; AND
The condition must be previously untreated; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 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.Compliance with Authority Required procedures - Streamlined Authority Code 5334
C5361 P5361 Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 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.Compliance with Authority Required procedures - Streamlined Authority Code 5361
C5362 P5362 Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.Compliance with Authority Required procedures - Streamlined Authority Code 5362
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