National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 7) (PB 58 of 2017) (Cth)

PB 58 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 7)

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 Minister for Sport, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated 25 JULY 2017

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 2017 (No. 7).

(2)  This Instrument may also be cited as PB 58 of 2017.

2  Commencement

This Instrument commences on 1 August 2017.

3Amendment of PB 79 of 2011

This Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

4  Schedules

  The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1— Amendments commencing on 1 August 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

1. Schedule 1, Part 1 (table item dealing with Nivolumab)

substitute:

Nivolumab	Injection concentrate for I.V. infusion 40 mg in 4 mL	Injection	Opdivo	BQ	MP	C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999	D
Injection concentrate for I.V. infusion 100 mg in 10 mL	Injection	Opdivo	BQ	MP	C6070 C6095 C6111 C6988 C6993 C6996 C6997 C6999	D

1. Schedule 1, Part 1 (table item dealing with Vinblastine, in the form Solution for I.V. injection containing vinblastine sulphate 10 mg in 10 mL, form of administration Injection, after brand Hospira Pty Limited)

insert brand:

Vinblastine Teva DZ MP D

1. Schedule 1, Part 2 (table item dealing with Nivolumab)

substitute:

Nivolumab	P6070 P6095 P6988 P6966	360	8
P6111 P6993 P6997 P6999	360	11

1. Schedule 3

insert in alphabetical order:

DZ Medsurge Healthcare Pty Ltd 92 124 728 892

1. Schedule 4 

substitute:

Nivolumab	C6070	P6070	Unresectable Stage III or Stage IV malignant melanoma Initial treatment 2 The condition must be negative for a BRAF V600 mutation; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 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 6070
C6095	P6095	Unresectable Stage III or Stage IV malignant melanoma Initial treatment 1 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 or a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 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 6095
C6111	P6111	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 3 mg per kg every 2 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6111
C6988	P6988	Stage IV clear cell variant renal cell carcinoma (RCC) Initial Treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; OR Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal. 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 6988
C6993	P6993	Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 6993
C6996	P6996	Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. 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 6996
C6997	P6997	Locally advanced or metastatic non-small cell lung cancer Grandfathering treatment Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must have stable or responding disease; AND Patient must have a WHO performance status of 0 or 1. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures - Streamlined Authority Code 6997
C6999	P6999	Locally advanced or metastatic non-small cell lung cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6999