PB 47 of 2023
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 5)
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.
Date 30 May 2023
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
[1] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
omit:
| | | Bortezomib‑Dr.Reddy's | RI | MP | C11099 C13745 | D |
[2] Schedule 1, Part 1, entry for Pembrolizumab
insert in numerical order in the column headed “Circumstances”: C14027 C14028 C14044
[3] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400; Number of Repeats: 6]
insert in numerical order in the column headed “Purposes”: P14027 P14028 P14044
[4] Schedule 2, entry for Fosaprepitant
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | FOSAPREPITANT-AFT | AE | MP | C6852 C6886 C6887 C6891 | | 1 | 5 | |
[5] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
omit:
| | | Ondansetron ODT GH | GQ | MP | C5743 | | 4 | 0 | C |
[6] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
omit:
| | | Ondansetron ODT GH | GQ | MP | C5743 | | 4 | 0 | C |
[7] Schedule 3,
omit:
GQ | Generic Health Pty Ltd | 93 110 617 859 |
[8] Schedule 3,
omit:
RI | Dr Reddy's Laboratories (Australia) Pty Ltd | 16 120 092 408 |
[9] Schedule 4, entry for Pembrolizumab
insert in numerical order after existing text:
| C14027 | P14027 | Advanced, metastatic or recurrent endometrial carcinoma
Initial treatment
Patient must have received prior treatment with platinum-based chemotherapy; AND
The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.
Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14027 |
| C14028 | P14028 | Advanced, metastatic or recurrent endometrial carcinoma
Transitioning from non-PBS to PBS-subsided supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND
The treatment must be occurring in a patient where each of the following is true: (i) the patient had received prior treatment with platinum-based chemotherapy, (ii) the patient was untreated at treatment initiation with each of: (a) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (b) tyrosine kinase inhibitor therapy, (iii) the patient's WHO performance status was no higher than 1 at treatment initiation, (iv) this drug is being prescribed in either: (a) a combination of pembrolizumab plus lenvatinib only, (b) as monotherapy where there was a contraindication/intolerance to the other drug in the combination - document the details in the patient's medical records, (v) disease progression has not occurred whilst on treatment, (vi) this prescription does not extend treatment beyond 24 months from the first administered dose.
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14028 |
| C14044 | P14044 | Advanced, metastatic or recurrent endometrial carcinoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND
Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 14044 |