Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p83
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 83/162)
Character Range: 15109800–15116401

be in place of emergency treatment of hyperkalaemia; AND
                                                                                                         Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; or
                                                                                                         Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this due to prior occurrence of hyperkalaemia; AND
                                                                                                         Must be treated by a specialist medical practitioner with experience in the diagnosis and management of chronic kidney disease.
C14346              P14346         CN14346          Idelalisib                                           Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Initial treatment
                                                                                                         The condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment; or
                                                                                                         The condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment; AND
                                                                                                         Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition; AND
                                                                                                         The condition must have relapsed or be refractory to at least one prior therapy; AND
                                                                                                         The condition must be CD20 positive; AND
                                                                                                         The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
C14363              P14363         CN14363          Carfilzomib                                          Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14363
                                                                                                         Continuing treatment for Cycles 3 to 12
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The treatment must be in combination with lenalidomide and dexamethasone; AND
                                                                                                         Patient must not have progressive disease 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