Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p26
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 26/69)
Character Range: 373020–379987

less than 10 g per L serum M protein.
C12849              P12849         Carfilzomib                                                                  Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 12849
                                                                                                                Continuing treatment ‑ once weekly treatment regimen
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be in combination with dexamethasone; AND
                                                                                                                Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
                                                                                                                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.
C12930              P12930         Carfilzomib                                                                  Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 12930
                                                                                                                Continuing treatment ‑ twice weekly treatment regimen
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be in combination with dexamethasone; AND
                                                                                                                Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
                                                                                                                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