Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p39
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 39/51)
Character Range: 141228–147042

- Supporting Information Form; and
                                                (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
                                                (4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
                                                Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
C16345  P16345  CN16345  Cladribine             Relapsing remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 16345
                                                Initial treatment
                                                The condition must be diagnosed by a neurologist; AND
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by 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 have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                Patient must be ambulatory (without assistance or support).
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
                                                Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
                                                The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.
C16346  P16346  CN16346  Fingolimod             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16346
                                                Continuing treatment
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
                                                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 have demonstrated compliance with, and an ability to tolerate this therapy.
                                                Patient must weigh 40 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