Commonwealth Coat of Arms of Australia

 

PB 116 of 2024

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (November Update) Instrument 2024

 

National Health Act 1953

 

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated   30 October 2024

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024
(PB 31 of 2024) 2

 

 

 

  1.                Name
  1.            This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (November Update) Instrument 2024
  2.            This instrument may also be cited as PB 116 of 2024.
  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 November 2024

1 November 2024

Note: This table relates only to the provisions of this instrument as originally made.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.

  1.             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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024)

  1.            Schedule 1, Part 1, entry for Avelumab
  1.            omit from the column headed “Circumstances”: C8947 C10023
  2.            insert in numerical order in the column headed “Circumstances”: C16053 C16085
  1.            Schedule 1, Part 2, entry for Avelumab [Maximum Amount: 1200 mg; Number of Repeats: 8]

omit from the column headed “Purposes”: P8947 substitute: P16053

  1.            Schedule 1, Part 2, entry for Avelumab [Maximum Amount: 1200 mg; Number of Repeats: 11]

omit from the column headed “Purposes”: P10023 substitute: P16085

  1.            Schedule 3, Part 1, omit entry for Circumstances Code “C8947”
  2.            Schedule 3, Part 1, omit entry for Circumstances Code “C10023”
  3.            Schedule 3, Part 1, after entry for Circumstances Code “C15832”

insert:

C16053

P16053

Avelumab

Stage IV (metastatic) Merkel Cell Carcinoma

Initial treatment

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 10 mg per kg every 2 weeks under this restriction; OR

The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.

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 16053

C16085

P16085

Avelumab

Stage IV (metastatic) Merkel Cell Carcinoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug 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 dose of 10 mg per kg every 2 weeks under this restriction; OR

The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 16085