Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p113
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 113/191)
Character Range: 10749372–10757302

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; AND
                                                    Golimumab                                                                                                                                                                  Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                    Secukinumab

                                                    Tofacitinib

                                                    Upadacitinib

C9069               P9069          CN9069           Golimumab                                                                                                                                                                  Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                    Secukinumab                                                                                                                                                                Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                                                                               The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                                                                                                                                                               The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                                                                                                                               The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                                                                                                                                                               Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                                                                                                                               All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
                                                                                                                                                                                                                               If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                                                                                                                               Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) a completed authority prescription form(s); and