Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p146
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 146/161)
Character Range: 14573174–14578595

first administered dose, once in a lifetime.
C13745              P13745         CN13745          Bortezomib                     Newly diagnosed systemic light chain amyloidosis
                                                                                   Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total
                                                                                   Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication.
C13752              P13752         CN13752          Daratumumab                    Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                   Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)
                                                                                   The condition must be confirmed by a histological diagnosis; AND
                                                                                   The treatment must be in combination with bortezomib and dexamethasone; AND
                                                                                   Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised); AND
                                                                                   Patient must be undergoing treatment with this drug in one of the following situations:
                                                                                    (i) for the first time, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.
                                                                                   Progressive disease is defined as at least 1 of the following
                                                                                   (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                   (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                   (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% 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.
                                                                                   Details of the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
                                                                                   Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented