Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p367
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 367/476)
Character Range: 3219561–3228003

or 40 mg per week
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
                                                                                                                                            Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
                                                                                                                                            Patient must not have developed disease progression 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.
Sevelamer                                                              C5530                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
                                                                       C9762                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
Sildenafil                                                             C11229                                                               Pulmonary arterial