Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p244
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 244/312)
Character Range: 17004430–17014564

may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C15903              P15903         CN15903          Bimekizumab                                                            Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - balance of supply
                                                                                                                           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.
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
C15904              P15904         CN15904          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Second and final continuing treatment prescription (treatment cycles 10 to 15 inclusive) of first-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND
                                                                                                                           The treatment must cease upon disease progression; OR
                                                                                                                           The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first.
C15905              P15905         CN15905          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial treatment in first-line therapy with ibrutinib - Dose titration (cycle 4)
                                                                                                                           The condition must be untreated with venetoclax at the time of the first dose of this drug; 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; AND
                                                                                                                           The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).
C15906              P15906         CN15906          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must cease upon disease progression; OR
                                                                                                                           The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first; AND
                                                                                                                           The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses).
C15907              P15907         CN15907          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           First continuing treatment (treatment cycles 5 to 9 inclusive) of first-line