Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p232
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 232/476)
Character Range: 2250121–2259834

disease.
                                                                       C9762                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
Lenalidomide                                                           C13782                                                               Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone
                                                                                                                                            Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND
                                                                                                                                            Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.
                                                                       C13785                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21‑day treatment cycle
                                                                                                                                            The condition must be newly diagnosed; AND
                                                                                                                                            The condition must be confirmed by a histological diagnosis; AND
                                                                                                                                            The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
                                                                                                                                            Patient must not have been treated with lenalidomide or bortezomib for this condition; AND
                                                                                                                                            The treatment must not exceed a total of 4 cycles under this restriction.
                                                                                                                                            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) 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