Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p138
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 138/381)
Character Range: 12418717–12427052

patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C12120              P12120         CN12120          Adalimumab                                                                                                      Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    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 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 12 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 12 months) 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.
C12122              P12122         CN12122          Adalimumab                                                                                                      Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                    First continuing treatment
                                                                                                                                                                    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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised 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 the following active joints, from at least 4, by at