Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p34
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 34/162)
Character Range: 14838573–14844605

(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.
C14039              P14039         CN14039          Selinexor                                            Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Dose requirement of 160 mg per week
                                                                                                         The condition must be confirmed by a histological diagnosis; AND
                                                                                                         Patient must be undergoing dual combination therapy limited to:
                                                                                                          (i) this drug, (ii) dexamethasone; AND
                                                                                                         Patient must have progressive disease after at least one prior therapy; AND
                                                                                                         Patient must not have previously received this drug for this condition.
                                                                                                         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.
                                                                                                         Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy
C14040              P14040         CN14040          Nicotine                                             Nicotine dependence
                                                                                                         The treatment must be as an aid to achieving abstinence from smoking; AND
                                                                                                         The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND
                                                                                                         Patient must have indicated they are ready to cease smoking; AND
                                                                                                         Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND
                                                                                                         Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support