Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p317
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 317/476)
Character Range: 2872945–2880817

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.
                                                                       C13768                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
                                                                                                                                            Patient must not have developed disease progression while receiving PBS‑subsidised 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.
Raltegravir                                                            C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination