Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p30
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 30/51)
Character Range: 104318–110297

with a specialist physician.
                                                Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C16323  P16323  CN16323  Dimethyl fumarate      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16323
                         Diroximel fumarate     Initial treatment
                         Fingolimod             The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                         Ofatumumab             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
                         Teriflunomide          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.
C16325  P16325  CN16325  Fingolimod             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16325
                                                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 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.
                                                Patient must weigh 40 kg or less.
                                                Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C16331  P16331  CN16331  Inclisiran             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16331
                                                Initial treatment
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must have symptomatic atherosclerotic cardiovascular disease; AND
                                                Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND
                                                Patient must have atherosclerotic disease in two or more