Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p59
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 59/69)
Character Range: 598800–606422

programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition; 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.
C15196              P15196         Dostarlimab                                                                  Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 15196
                                                                                                                Transitioning from non‑PBS to PBS‑subsidised treatment ‑ Grandfather treatment
                                                                                                                Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND
                                                                                                                Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 May 2024; AND
                                                                                                                The condition must be, prior to initiation of non‑PBS‑subsidised treatment with this drug, unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND
                                                                                                                The condition must be, prior to initiation of non‑PBS‑subsidised treatment with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic 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; AND
                                                                                                                The treatment must be, at initiation of non‑PBS‑subsidised treatment with this drug, used in combination with platinum‑containing chemotherapy; AND
                                                                                                                Patient must not have developed disease progression while receiving non‑PBS‑subsidised treatment with this drug for this condition.
                                                                                                                Patient must not be undergoing continuing PBS‑subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.
C15205              P15205         Dostarlimab                                                                  Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 15205
                                                                                                                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 not be undergoing continuing PBS‑subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.
C15455              P15455         Atezolizumab                                                                 Resected early stage (Stage II to IIIA) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 15455
                                                                                                                1,875 mg administered once every 3 weeks
                                                                                                                Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death‑1/ligand 1 (PD‑1/PD‑L1) inhibitor therapy; OR
                                                                                                                Patient must be continuing existing PBS‑subsidised treatment with this drug; OR
                                                                                                                Patient must be both: (i) transitioning from existing non‑PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death‑1/ligand 1 (PD‑1/PD‑L1) inhibitor therapy at the time this drug was initiated.
                                                                                                                Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.