Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p36
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 36/51)
Character Range: 129610–133689

following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C16339  P16339  CN16339  Risankizumab           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)
                                                Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                Patient must have had 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 28 weeks of treatment under this restriction.
                                                Must be treated by a rheumatologist; OR
                                                Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                Patient must be at least 18 years of age.
                                                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 4 weeks 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