Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p68
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 68/69)
Character Range: 658639–666289

with cytarabine                                                 Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Consolidation therapy
                                                                                                                The treatment must be for consolidation treatment following induction treatment with this product; AND
                                                                                                                The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND
                                                                                                                The treatment must not exceed two cycles of consolidation therapy under this restriction.
                                                                                                                This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.

                                                                                                                Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.
C16264              P16264         Pembrolizumab                                                                Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 16264
                                                                                                                Initial treatment - 6 weekly treatment regimen
                                                                                                                Patient must not have previously been treated for this condition in the metastatic setting; OR
                                                                                                                The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; 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 not exceed a total of 4 doses under this restriction.
C16280              P16280         Pembrolizumab                                                                Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 16280
                                                                                                                Initial treatment - 3 weekly treatment regimen
                                                                                                                Patient must not have previously been treated for this condition in the metastatic setting; OR
                                                                                                                The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; 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 not exceed a total of 7 doses under this restriction.

Part 2—Variation rules