Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p158
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 158/191)
Character Range: 11115738–11124129

procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply
                                                                                                                                                                                                                               Must be treated by a paediatric rheumatologist; or
                                                                                                                                                                                                                               Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 16 or 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 or 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 or 24 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions for patients 30 kg or over.  or
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions for patients under 30 kg.
C9478               P9478          CN9478           Tocilizumab                                                                                                                                                                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 active joint count of fewer than 10 active (swollen and tender) joints; or
                                                                                                                                                                                                                               (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
                                                                                                                                                                                                                               (c) a reduction in the number of