Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p115
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 115/161)
Character Range: 14414992–14422836

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 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.
C13443              P13443         CN13443          Atezolizumab                   Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13443
                                                                                   Initial treatment - 3 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 non-small cell lung cancer; AND
                                                                                   Patient must have a WHO performance status of 0 or 1; AND
                                                                                   The treatment must be the sole PBS-subsidised systemic anti-cancer 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.
C13445              P13445         CN13445          Nivolumab                      Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13445
                                                                                   Initial treatment as second-line drug therapy
                                                                                   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 treatment must be the sole PBS-subsidised systemic anti-cancer 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.
                                                                                   The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
                                                                                   Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C13446              P13446         CN13446          Atezolizumab                   Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 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