Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p12
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 12/476)
Character Range: 756760–764265

drug, unless the 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.
Adalimumab                                                             C12120                                                               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.
                                                                                                                                            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.
                                                                       C14061                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
                                                                                                                                            Must be treated by a paediatric rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                                                            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.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            (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 active joints, from at least 4, by at least 50%:
                                                                                                                                            (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                            (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and