Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p377
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 377/381)
Character Range: 13798501–13808570

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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 12934
                                                                                                                                                                    Initial treatment - twice weekly treatment regimen
                                                                                                                                                                    The condition must be confirmed by a histological diagnosis; AND
                                                                                                                                                                    The treatment must be in combination with dexamethasone; AND
                                                                                                                                                                    Patient must have progressive disease after at least one prior therapy; AND
                                                                                                                                                                    Patient must have undergone or be ineligible for a stem cell transplant; AND
                                                                                                                                                                    Patient must not have previously received this drug for this condition; AND
                                                                                                                                                                    Patient must not receive more than three cycles of treatment 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.
C12976              P12976         CN12976          Tofacitinib                                                                                                     Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - balance of supply
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                    Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
C12979              P12979         CN12979          Amifampridine                                                                                                   Lambert-Eaton myasthenic syndrome (LEMS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    The condition must not be any of:
                                                                                                                                                                     (i) myasthenia