Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p237
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 237/476)
Character Range: 2285799–2291882

progressive disease
                                                                                                                                            The condition must be confirmed by a histological diagnosis; AND
                                                                                                                                            The treatment must be as monotherapy; OR
                                                                                                                                            The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
                                                                                                                                            Patient must have progressive disease after at least one prior therapy; AND
                                                                                                                                            Patient must have undergone or be ineligible for a primary stem cell transplant.
                                                                                                                                            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.
                                                                                                                                            The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
                                                                                                                                            (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
                                                                                                                                            (2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and
                                                                                                                                            (3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and
                                                                                                                                            (4) details of the basis of the diagnosis of progressive disease or failure to respond; and
                                                                                                                                            (5) nomination of which disease activity parameters will be used to assess response.
                                                                                                                                            To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:
                                                                                                                                            (a) the level of serum monoclonal protein; or
                                                                                                                                            (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
                                                                                                                                            (c) the serum level of free kappa