Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p8
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 8/381)
Character Range: 11454057–11463454

Stage IIIB, IIIC or IIID melanoma; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less.
C10161              P10161         CN10161          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10161
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    The treatment must be commenced in a hospital-based movement disorder clinic.
C10162              P10162         CN10162          Fingolimod                                                                                                      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10162
                                                                                                                                                                    Initial treatment
                                                    Ofatumumab                                                                                                      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
                                                    Ozanimod                                                                                                        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).
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10170              P10170         CN10170          Cladribine                                                                                                      Relapsing remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10170
                                                                                                                                                                    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).
                                                                                                                                                                    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.
C10171              P10171         CN10171          Cladribine