Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p114
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 114/161)
Character Range: 14406706–14415537

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.
C13434              P13434         CN13434          Tepotinib                      Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13434
                                                                                   Initial treatment
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have a WHO performance status of 2 or less; AND
                                                                                   Patient must have evidence of MET exon 14 skipping alterations in tumour material.
C13437              P13437         CN13437          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.
C13441              P13441         CN13441          Tepotinib                      Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13441
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
C13442              P13442         CN13442          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; 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,