Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p283
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 283/476)
Character Range: 2625480–2636192

(i) confirmation of genetic diagnosis of SMA; and
                                                                                                                                            (ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)
Ocrelizumab                                                            C7386                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 7386
                                                                                                                                            Continuing treatment
                                                                                                                                            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
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
                                                                                                                                            Must be treated by a neurologist.
                                                                       C7699                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 7699
                                                                                                                                            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 neurologist.
                                                                                                                                            Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
                                                                       C9523                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9523
                                                                                                                                            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 neurologist.
                                                                                                                                            Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
                                                                       C9635                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9635
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised