National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 12) (Cth)

PB 132 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 12)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy 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.

Date 21 December 2021

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

________________________________________________________________________

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011)   2

1. Name

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 12).

(2)This instrument may also be cited as PB 132 of 2021.

1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 January 2022	1 January 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)     Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. Schedules

Each instrument that is specified in a Schedule to this instrument 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

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

1. Schedule 1, Part 1, entry for Arsenic

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Arsenic Trioxide-AFT AE MP C4793 C5997 C6018 D

1. Schedule 1, Part 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg in 100 mL

insert in numerical order in the column headed “Circumstances”: C12470 C12483

1. Schedule 1, Part 2, entry for Cetuximab

substitute:

Cetuximab	P4788	550	5
P12016 P12470	550	11
P4912	550	18
P4785 P4794 P4908 P12045 P12483	880	0

1. Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron ODT Lupin HQ MP C5743 4 0 C

1. Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ondansetron ODT Lupin HQ MP C5743 4 0 C

1. Schedule 3, after details relevant for Responsible Person code GX

insert:

HQ Generic Health Pty Ltd 93 110 617 859

1. Schedule 3

omit:

QY Pro Pharmaceuticals Group Pty Ltd 20 605 457 430

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

insert:

TY Apotex Pty Ltd 52 096 916 148

1. Schedule 4, entry for Cetuximab

insert in numerical order after existing text:

C12470	P12470	Metastatic colorectal cancer Continuing treatment The treatment must be in combination with PBS-subsidised encorafenib for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12470
C12483	P12483	Metastatic colorectal cancer Initial treatment The treatment must be in combination with PBS-subsidised encorafenib for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 12483