Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p36
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 36/69)
Character Range: 443991–451705

P13448         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.
                                                                                                                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         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.
                                                                                                                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.
C13726              P13726         Pembrolizumab                                                                Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13726
                                                                                                                Initial treatment
                                                                                                                Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR
                                                                                                                Patient must