Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p48
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 48/69)
Character Range: 522991–530935

as having active disease with less than 10 g per L serum M protein.
C14364              P14364         Carfilzomib                                                                  Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 14364
                                                                                                                Continuing treatment for Cycles 13 onwards
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be in combination with lenalidomide and dexamethasone; AND
                                                                                                                Patient must not have progressive disease while receiving treatment with this drug for this condition.
                                                                                                                Progressive disease is defined as at least 1 of the following:
                                                                                                                (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                (b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                                                (c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
                                                                                                                (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
                                                                                                                (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
                                                                                                                (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C14387                             Fosnetupitant with palonosetron                                              Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti‑cancer therapy; AND
                                                                                                                The treatment must be in combination with dexamethasone, unless contraindicated; AND
                                                                                                                Patient must be unable to swallow; OR
                                                                                                                Patient must be contraindicated to oral anti‑emetics.
C14389              P14389         Carfilzomib                                                                  Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 14389
                                                                                                                Initial treatment for Cycles 1 to 3
                                                                                                                The condition must be confirmed by a histological diagnosis; AND
                                                                                                                The treatment must be in combination with lenalidomide and dexamethasone; AND
                                                                                                                Patient must have progressive disease after at least one prior therapy; AND
                                                                                                                Patient must not have previously received this drug for this condition.
                                                                                                                Progressive disease is defined as at least 1 of the following:
                                                                                                                (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                (b) at least a 25% increase in 24‑hour urinary light chain M