Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p116
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 116/161)
Character Range: 14422326–14429541

13446
                                                                                   Initial treatment - 4 weekly treatment regimen
                                                                                   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; 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
                                                                                   The condition must have progressed on or after prior platinum based chemotherapy.  or
                                                                                   The condition must have progressed after treatment with tepotinib.
C13448              P13448         CN13448          Atezolizumab                   Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 13448
                                                                                   Initial treatment 1
                                                                                   Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND
                                                                                   The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
                                                                                   Patient must 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 mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.
C13451              P13451         CN13451          Atezolizumab                   Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 13451
                                                                                   1,680 mg administered once every 4 weeks, or 840 mg every 2 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; AND
                                                                                   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; AND
                                                                                   Patient must be undergoing treatment that does