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
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Contents
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024
(PB 31 of 2024) 2
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Note: This table relates only to the provisions of this instrument as originally made.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.
This instrument is made under subsection 100(2) of the National Health Act 1953.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 2024 (PB 31 of 2024)
omit from the column headed “Purposes”: P8947 substitute: P16053
omit from the column headed “Purposes”: P10023 substitute: P16085
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 |