Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p239
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 239/476)
Character Range: 2297774–2306211

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.
                                                                       C13805                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND
                                                                                                                                            The treatment must be as monotherapy; OR
                                                                                                                                            The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
                                                                       C13810                                                               Myelodysplastic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            The treatment must be limited to a maximum duration of 16 weeks; AND
                                                                                                                                            Patient must be classified as Low risk or Intermediate‑1 according to the International Prognostic Scoring System (IPSS); AND
                                                                                                                                            Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
                                                                                                                                            Patient must be red blood cell transfusion dependent.
                                                                                                                                            Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias.
                                                                                                                                            Classification of a patient as Intermediate‑1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:
                                                                                                                                            1. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias; OR
                                                                                                                                            2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
                                                                                                                                            3. less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
                                                                                                                                            4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR
                                                                                                                                            5. 5%‑10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
                                                                                                                                            6. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
                                                                                                                                            7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
                                                                                                                                            Classification of a patient as red blood cell transfusion dependent requires that:
                                                                                                                                            (i) the patient has been transfused within the last 8 weeks; and
                                                                                                                                            (ii) the patient