PB 6 of 2025
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (February Update) Instrument 2025
National Health Act 1953
I, REBECCA RICHARDSON, 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 30th January 2025
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
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 February 2025 | 1 February 2025 |
Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| nab-PACLITAXEL JUNO | C4657 C6106 C6119 |
insert:
C16264 | P16264 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 6 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 4 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 16264 |
C16280 | P16280 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 16280 |