Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p236
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 236/476)
Character Range: 2278245–2286622

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) or if relevant (e), (f) or (g) should be stated/declared. 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 in 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).
                                                                       C13801                                                               Myelodysplastic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received PBS‑subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND
                                                                                                                                            Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS‑subsidised therapy with lenalidomide; AND
                                                                                                                                            Patient must not have progressive disease; AND
                                                                                                                                            The condition must not have progressed to acute myeloid leukaemia.
                                                                                                                                            The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.
                                                                                                                                            The following evidence of response must be provided at each application:
                                                                                                                                            (i) a haemoglobin level taken within the last 4 weeks; and
                                                                                                                                            (ii) the date of the last transfusion; and
                                                                                                                                            (iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;
                                                                                                                                            All reports must be documented in the patient's medical records.
                                                                                                                                            For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) 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).
                                                                       C13803                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment as monotherapy or dual combination therapy with dexamethasone for 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