Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p34
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 34/69)
Character Range: 430231–437008

not have previously been treated for this condition in the metastatic setting; OR
                                                                                                                The condition must have progressed after treatment with tepotinib; 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 non‑small cell lung cancer; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                The treatment must be in combination with platinum‑based chemotherapy for the first two cycles; AND
                                                                                                                The treatment must be in combination with ipilimumab.
C13437              P13437         Pembrolizumab                                                                Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 13437
                                                                                                                Continuing treatment ‑ 6 weekly treatment regimen
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.
C13442              P13442         Atezolizumab                                                                 Resected early stage (Stage II to IIIA) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 13442
                                                                                                                1,200 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.
                                                                                                                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