Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p21
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 21/51)
Character Range: 65461–70789

practitioner in consultation with a specialist physician.
C16303  P16303  CN16303  Siponimod              Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16303
                                                Continuing treatment (including recommencement of treatment)
                                                The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                Patient must be ambulatory, with/without assistance/support; AND
                                                Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16305  P16305  CN16305  Risankizumab           Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
                                                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 3 biological medicines for this condition within 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 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.
                                                An adequate response to treatment is defined as:
                                                an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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) 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 major 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 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).
                                                The authority application must be made in writing and must include:
                                                (1) details of the proposed prescription; and
                                                (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                An