Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p266
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 266/312)
Character Range: 17129115–17136727

must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                                           The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
                                                                                                                           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)].
C15949              P15949         CN15949          Bimekizumab                                                            Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - balance of supply
                                                                                                                           Patient must have received insufficient therapy with this drug 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 ankylosing spondylitis.
C15950              P15950         CN15950          Bimekizumab                                                            Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
                                                                                                                           either of the following:
                                                                                                                           (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                           (b) a reduction in the number of the following major active joints, from at least