Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p33
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 33/162)
Character Range: 14832884–14839046

30% lower than that stated in the first Initial 1 treatment authority application).
C14034              P14034         CN14034          Abiraterone and methylprednisolone                   Metastatic castration sensitive carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                         The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND
                                                    Apalutamide                                          Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or
                                                                                                         Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND
                                                    Darolutamide                                         Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
                                                                                                         Patient must be undergoing concurrent androgen deprivation therapy.
                                                    Enzalutamide

C14037              P14037         CN14037          Selinexor                                            Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 100 mg per week
                                                                                                         Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND
                                                                                                         Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
                                                                                                          (a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND
                                                                                                         Patient must not have developed disease progression while receiving treatment with 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