Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p95
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 95/162)
Character Range: 15166516–15173495

drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C14387              P14387         CN14387          Fosnetupitant with palonosetron                      Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                         The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy; AND
                                                                                                         The treatment must be in combination with dexamethasone, unless contraindicated; AND
                                                                                                         Patient must be unable to swallow.  or
                                                                                                         Patient must be contraindicated to oral anti-emetics.
C14389              P14389         CN14389          Carfilzomib                                          Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14389
                                                                                                         Initial treatment for Cycles 1 to 3
                                                                                                         The condition must be confirmed by a histological diagnosis; AND
                                                                                                         The treatment must be in combination with lenalidomide and 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.
                                                                                                         Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the 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 once only through the Authority application for lenalidomide.
C14396              P14396         CN14396          Bimekizumab                                          Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with