National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 6) (Cth)

PB 65 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 6)

National Health Act 1953

___________________________________________________________________________

I, MARIANA CRANK, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access 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              29 JUNE 2021

MARIANA CRANK

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 6).

(2)This Instrument may also be cited as PB 65 of 2021.

1. Commencement

This Instrument commences on 1 July 2021.

1. Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (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. Part 1, Division 1, Section 3, definition for “diluent fee”

omit: $5.44              substitute: $5.50

1. Part 1, Division 1, Section 3, definition for “dispensing fee”

omit: $7.74              substitute: $7.78

1. Part 1, Division 1, Section 3, definition for “distribution fee”

omit: $27.45            substitute: $27.75

1. Part 1, Division 1, Section 3, definition for “preparation fee”

omit: $85.78            substitute: $86.28

1. Schedule 1, Part 1, after entry for Cabazitaxel in the form Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

insert:

Solution concentrate for I.V. infusion 60 mg in 6 mL Injection Cabazitaxel Ever Pharma IT MP C4662 D

1. Schedule 1, Part 1, entry for Carboplatin

omit:

Solution for I.V. injection 150 mg in 15 mL Injection DBL Carboplatin PF MP D

1. Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11930

1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11985

1. Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 120; Number of Repeats: 3]

insert in numerical order in the column headed “Purposes”: P11930    

1. Schedule 1, Part 2, after entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 3]

insert:

P11985 360 8

1. Schedule 3, after details relevant to Responsible Person code HX

insert:

IT InterPharma Pty Ltd 19    99 877 899

1. Schedule 3, details relevant to the Responsible Person codes; OC and OD

omit from the column headed “Responsible Person”: Accord Healthcare Pty Ltd          substitute: Accord Healthcare Pty. Ltd.

1. Schedule 4, entry for Ipilimumab

insert in numerical order after existing text:

C11930 P11930 Unresectable malignant mesothelioma
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with PBS-subsidised nivolumab for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum total of 24 months in a lifetime for this condition. Compliance with Authority Required procedures - Streamlined Authority Code 11930

1. Schedule 4, entry for Nivolumab

insert in numerical order after existing text:

C11985 P11985 Unresectable malignant mesothelioma
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with PBS-subsidised ipilimumab, unless an intolerance to ipilimumab of a severity necessitating permanent treatment withdrawal of ipilimumab; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
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 11985