Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p240
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 240/476)
Character Range: 2305531–2313612

blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
                                                                                                                                            Classification of a patient as red blood cell transfusion dependent requires that:
                                                                                                                                            (i) the patient has been transfused within the last 8 weeks; and
                                                                                                                                            (ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS‑subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.
                                                                                                                                            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:
                                                                                                                                            (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and
                                                                                                                                            (b) details (date, unique identifying number/code or provider number) of the full blood examination report; and
                                                                                                                                            (c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate‑1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS ‑5q is acceptable); and
                                                                                                                                            (d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.
                                                                                                                                            All the reports must be documented in the patient's medical records.
                                                                                                                                            If the application is submitted through HPOS upload or mail, it must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C13811                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21‑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 form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
                                                                                                                                            The treatment must not exceed a total of 4 cycles under this restriction.
                                                                       C13812                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation
                                                                                                                                            The condition must be newly diagnosed; AND
                                                                                                                                            The condition must be confirmed by a histological 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