Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p46
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 46/69)
Character Range: 509159–516830

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.
C14196              P14196         Trabectedin                                                                  Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 14196
                                                                                                                Initial treatment
                                                                                                                Patient must have an ECOG performance status of 2 or less; AND
                                                                                                                Patient must have received prior chemotherapy treatment including an anthracycline; AND
                                                                                                                The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
                                                                                                                The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round‑cell, (iv) pleomorphic.
                                                                                                                This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
C14197              P14197         Trabectedin                                                                  Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 14197
                                                                                                                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 treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition.
                                                                                                                This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
C14324              P14324         Pembrolizumab                                                                Recurrent, unresectable or metastatic triple negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 14324
                                                                                                                The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND
                                                                                                                The condition must have been (up until this drug therapy) untreated with programmed cell death‑1/ligand 1 (PD‑1/PD‑L1) inhibitor therapy in breast cancer; 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; AND
                                                                                                                The treatment must be in combination with chemotherapy; AND
                                                                                                                The condition must have both: (i) programmed cell death ligand 1 (PD‑L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation.
                                                                                                                Patient must be undergoing initial treatment with this drug ‑ this is the first prescription for this drug; OR
                                                                                                                Patient must be undergoing continuing treatment with this drug ‑ both the following are true: (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up