PB 95 of 2018
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, NATASHA PLOENGES, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.
Dated 26 October 2018
NATASHA PLOENGES
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 2018 (No. 10).
(2) This Instrument may also be cited as PB 95 of 2018.
2 Commencement
This Instrument commences on 1 November 2018.
3 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] Schedule 1, Part 1, entry for Pembrolizumab, in the form Solution concentrate for I.V. infusion 100 mg in 4 mL
insert in numerical order in the column headed “Circumstances”: C8122 C8123 C8124
[2] Schedule 1, Part 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)
omit:
| | | Pemetrexed APOTEX | TX | MP | C4792 C7195 | D |
[3] Schedule 1, Part 2, entry for Pembrolizumab
substitute:
Pembrolizumab | P7606 P7610 P7773 P8122 P8123 P8124 | 200 | 6 |
| P6806 P6817 | 240 | 5 |
| P6801 | 240 | 7 |
[4] Schedule 4, entry for Pembrolizumab
insert in numerical order after existing text:
| C8122 | P8122 | Previously untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
Patient must not have previously been treated for this condition in the metastatic setting; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must express programmed cell death ligand 1 (PD-L1) with a tumour score of at least 50% in the tumour sample; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
The treatment must not exceed a total of 7 doses at a maximum dose of 200 mg every 3 weeks for this condition under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 8122 |
| C8123 | P8123 | Previously untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 November 2018; AND
Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS subsidised treatment with this drug for this condition; AND
The condition must express programmed cell death ligand 1 (PD-L1) with a tumour score of at least 50% in the tumour sample prior to initiation of non-PBS subsidised treatment with this drug for this condition; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
The treatment must not exceed 35 doses in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks, with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8123 |
| C8124 | P8124 | Previously untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The treatment must not exceed 35 doses in total or up to 24 months of treatment, at a dose of 200 mg every 3 weeks, with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 8124 |