National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 6) (PB 48 of 2017) (Cth)

PB 48 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 6)

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 28 JUNE 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. 6).

(2)  This Instrument may also be cited as PB 48 of 2017.

2  Commencement

This Instrument commences on 1 July 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  The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 July 2017

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

1. Section 3, Definition for diluent fee

omit: $5.14 substitute:  $5.21

1. Section 3, Definition for dispensing fee

omit: $7.02 substitute: $7.15

1. Section 3, Definition for distribution fee

omit: $25.92 substitute: $26.28

1. Section 3, Definition for preparation fee

omit: $83.22 substitute: $83.83

1. Schedule 1, Part 1 (table item dealing with Doxorubicin, in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single does vial)

omit:

Doxorubicin MYX OC MP D

1. Schedule 1, Part 1 (table item dealing with Epirubicin, in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL)

omit:

Hospira Pty Limited PF MP D

1. Schedule 1, Part 1 (table item dealing with Epirubicin, in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL)

omit:

DBL Epirubicin Hydrochloride Injection PF MP D

1. Schedule 1, Part 1 (table item dealing with Epirubicin, in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL)

omit:

Hospira Pty Limited PF MP D

1. Schedule 1, Part 1 [table item dealing with Gemcitabine, in the forms: Powder for I.V. infusion 1 g (as hydrochloride); Powder for I.V. infusion 2 g (as hydrochloride); and Powder for I.V. infusion 200 mg (as hydrochloride)]

omit:

DBL Gemcitabine for Injection PF MP D

10  Schedule 1, Part 1 (table item dealing with Irinotecan, in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL)

omit:

Irinotecan MYX OC MP D

11  Schedule 1, Part 1 (table item dealing with Methotrexate, in the forms: Injection 50 mg in 2 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial)

omit:

Methotrexate MYX OC MP D

12  Schedule 1, Part 1 [table item dealing with Mitozantrone, in the form Injection 20 mg (as hydrochloride) in 10 mL]

omit:

Hospira Pty Limited PF MP D

13  Schedule 1, Part 1 (table item dealing with Pembrolizumab, in the form Powder for injection 50 mg)

omit from the column headed ‘Circumstances’:      C6828, C6829

14  Schedule 1, Part 1 (table item dealing with Pembrolizumab, after the form Powder for injection 50 mg)

Insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 100 mg in 4 mL Injection Keytruda MK MP C6801
C6806
C6817 D

15  Schedule 1, Part 1 [table item dealing with Topotecan, in the form Powder for I.V. infusion 4 mg (as hydrochloride)]

omit:

Topotecan Agila YA MP C6238 D

16  Schedule 1, Part 2 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab	P6806	240	5
P6817
P6801	240	7

17  Schedule 4 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab	C6801	P6801	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 6801
C6806	P6806	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 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 6806
C6817	P6817	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 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 6817