Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p60
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 60/69)
Character Range: 606057–613744

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.
                                                                                                                The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum‑based chemotherapy; AND
                                                                                                                The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND
                                                                                                                The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD‑L1) expression on at least 50% of tumour cells; AND
                                                                                                                The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition.
                                                                                                                Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.
C15471              P15471         Nivolumab                                                                    Resectable non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 15471
                                                                                                                The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND
                                                                                                                The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be in combination with platinum‑based chemotherapy.
                                                                                                                Patient must not be undergoing treatment with more than 3 PBS‑subsidised doses of this drug per lifetime for this indication.
                                                                                                                In non‑squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.
C15485              P15485         Avelumab                                                                     Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 15485
                                                                                                                Maintenance therapy ‑ Initial treatment
                                                                                                                Patient must have received first‑line platinum‑based chemotherapy; AND
                                                                                                                Patient must not have progressive disease following first‑line platinum‑based chemotherapy; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; 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 this condition.
C15500              P15500         Durvalumab                                                                   Unresectable Stage III non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 15500
                                                                                                                Initial treatment
                                                                                                                Patient must have received platinum based chemoradiation therapy; AND
                                                                                                                The condition must not