Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p241
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 241/476)
Character Range: 2312932–2319915

diagnosis; AND
                                                                                                                                            Patient must be ineligible for a primary stem cell transplantation; AND
                                                                                                                                            The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
                                                                                                                                            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) confirmation of ineligibility for prior stem cell transplant; and
                                                                                                                                            (3) 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 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 response, 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) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.
                                                                                                                                            All reports must be documented in the patient's medical records.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C13813                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28‑day treatment cycles)
                                                                                                                                            Patient must have received PBS‑subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND
                                                                                                                                            The treatment must