Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p40
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 40/51)
Character Range: 146117–151323

kg or less.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16347  P16347  CN16347  Siponimod              Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16347
                                                Initial treatment
                                                The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR
                                                The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                Patient must be ambulatory, with/without assistance/support; AND
                                                Patient must have mild disability in at least 3 functional systems; OR
                                                Patient must have moderate disability in at least 1 functional system.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
                                                Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
                                                Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status.
C16348  P16348  CN16348  Risankizumab           Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2025; AND
                                                Patient must be receiving treatment with this drug for this condition at the time of application; AND
                                                Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have demonstrated an adequate response to treatment with this drug for this condition if the patient has received non-PBS-subsidised treatment for at least 12 weeks; AND
                                                Patient must not receive more than 24 weeks of treatment under this restriction.
                                                Must be treated by a rheumatologist; OR
                                                Must be treated by a clinical immunologist with expertise in the