Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p376
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 376/381)
Character Range: 13791876–13799049

chronological age is 2.5 years or less); AND
                                                                                                                                                                    5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2 ; AND
                                                                                                                                                                    6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
                                                                                                                                                                    7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                                                                                                    Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                                                                                                    In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C12930              P12930         CN12930          Carfilzomib                                                                                                     Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 12930
                                                                                                                                                                    Continuing treatment - twice weekly treatment regimen
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with dexamethasone; AND
                                                                                                                                                                    Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
                                                                                                                                                                    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.
C12934              P12934         CN12934          Carfilzomib                                                                                                     Multiple myeloma