Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p66
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 66/69)
Character Range: 644881–653669

kg.
C16053              P16053         Avelumab                                                                     Stage IV (metastatic) Merkel Cell Carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 16053

                                                                                                                Initial treatment

                                                                                                                The treatment must be the sole PBS-subsidised therapy for this condition; AND

                                                                                                                The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction; OR

                                                                                                                The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C16085              P16085         Avelumab                                                                     Stage IV (metastatic) Merkel Cell Carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 16085

                                                                                                                Continuing treatment

                                                                                                                The treatment must be the sole PBS-subsidised therapy for this condition; AND

                                                                                                                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 maximum dose of 10 mg per kg every 2 weeks under this restriction; OR
                                                                                                                The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.
C16151              P16151         Nivolumab with relatlimab                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 16151
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                                                                                                Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.
                                                                                                                The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.

                                                                                                                The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.
C16187              P16187         Daunorubicin with cytarabine                                                 Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Induction therapy
                                                                                                                Patient must not have received prior chemotherapy as induction therapy for this condition; 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 condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND
                                                                                                                Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND
                                                                                                                Patient must have a World Health Organisation (WHO)