Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p47
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 47/69)
Character Range: 516467–524256

on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to 6 repeat prescriptions; OR
                                                                                                                Patient must be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions.
C14326              P14326         Obinutuzumab                                                                 Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 14326
                                                                                                                Combination use with chlorambucil only
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                The condition must be previously untreated; AND
                                                                                                                The treatment must be in combination with chlorambucil; AND
                                                                                                                The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
                                                                                                                Treatment must be discontinued in patients who experience disease progression whilst on this treatment.
C14363              P14363         Carfilzomib                                                                  Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 14363
                                                                                                                Continuing treatment for Cycles 3 to 12
                                                                                                                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.
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