Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p245
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 245/312)
Character Range: 17013230–17020259

(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 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.
C15916              P15916         CN15916          Bimekizumab                                                            Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
                                                                                                                           The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                           The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                           All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
                                                                                                                           If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                           Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                           The authority application must be made in writing and