Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p235
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 235/476)
Character Range: 2271576–2278645

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.
                                                                       C13791                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment with lenalidomide monotherapy in newly diagnosed disease
                                                                                                                                            The treatment must be as monotherapy; AND
                                                                                                                                            The condition must be confirmed by a histological diagnosis; AND
                                                                                                                                            Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND
                                                                                                                                            Patient must not have progressive disease following autologous stem cell transplant (ASCT).
                                                                                                                                            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) the date the autologous stem cell transplant was performed; and
                                                                                                                                            (3) nomination of which disease activity parameters will be used to assess progression.
                                                                                                                                            To enable confirmation of eligibility for treatment, the 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 and lambda light chains; or
                                                                                                                                            (d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
                                                                                                                                            (e) if present, the size and location of lytic bone lesions (not including compression fractures); or
                                                                                                                                            (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
                                                                                                                                            (g) if present, the level of hypercalcaemia, corrected for albumin concentration.
                                                                                                                                            As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d)