Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p9
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 9/381)
Character Range: 11463174–11474117

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.
C10171              P10171         CN10171          Cladribine                                                                                                      Relapsing remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10171
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated 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; 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.
                                                                                                                                                                    The prescriber should request authority approval 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.
C10172              P10172         CN10172          Fingolimod                                                                                                      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10172
                                                                                                                                                                    Continuing treatment
                                                    Ofatumumab                                                                                                      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
                                                    Ozanimod                                                                                                        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.
C10197              P10197         CN10197          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10197
                                                                                                                                                                    Maintenance therapy
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    Patient must have been commenced on treatment in a hospital-based movement disorder clinic.
C10198              P10198         CN10198          Fingolimod                                                                                                      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10198
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    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 by accompanying 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