Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p36
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 36/162)
Character Range: 14851651–14858087

in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or
                                                                                                         Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND
                                                                                                         Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.
C14045              P14045         CN14045          Selinexor                                            Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must be undergoing triple combination therapy limited to:
                                                                                                          (i) this drug, (ii) bortezomib, (iii) dexamethasone; or
                                                                                                         Patient must be undergoing dual combination therapy limited to:
                                                                                                          (i) this drug, (ii) dexamethasone; 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 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.
C14047              P14047         CN14047          Cannabidiol                                          Seizures of the Lennox-Gastaut syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Patient must have a diagnosis of Lennox-Gastaut syndrome confirmed by an electroencephalogram (EEG) that showed a pattern of slow (less than 3.0 hertz) spike-and-wave discharges with generalised paroxysmal fast activity (sleep recording should be obtained where it is possible); AND
                                                                                                         Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of generalised seizures;