Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p151
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 151/191)
Character Range: 11061530–11070534

by a clinical immunologist with expertise in the management of rheumatoid arthritis; 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.
C9386               P9386          CN9386           Adalimumab                                                                                                                                                                 Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
                                                    Etanercept                                                                                                                                                                 Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Tocilizumab                                                                                                                                                                Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient 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 24 months) 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 24 months) to complete 16 weeks of treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
C9388               P9388          CN9388           Etanercept                                                                                                                                                                 Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
                                                                                                                                                                                                                               Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                                                                                                                               Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
                                                                                                                                                                                                                               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 this drug for this condition during the current treatment cycle; AND
                                                                                                                                                                                                                               Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               An adequate response to treatment is defined as
                                                                                                                                                                                                                               an ESR no greater than 25 mm per hour or a 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) an