Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p271
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 271/476)
Character Range: 2537780–2547931

transplant unit.
                                                                       C9693                                                                Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 9693
                                                                                                                                            Management (initiation, stabilisation and review of therapy)
                                                                                                                                            Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
                                                                                                                                            The treatment must be under the supervision and direction of a transplant unit.
                                                                       C9809                                                                WHO Class III, IV or V lupus nephritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 9809
                                                                                                                                            Management
                                                                                                                                            The condition must be proven by biopsy.
                                                                                                                                            Must be treated by a nephrologist or in consultation with a nephrologist.
                                                                                                                                            The name of the consulting nephrologist must be included in the patient medical records.
Natalizumab                                                            C13625                                                               Clinically definite relapsing‑remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 13625
                                                                                                                                            Must be treated by a neurologist.
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must be ambulatory (without assistance or support); 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
                                                                                                                                            The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                                                                                                            Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
                                                                                                                                            The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
                                                                                                                                            Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
                                                                                                                                            For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
                                                                       C13718                                                               Clinically definite relapsing‑remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 13718
                                                                                                                                            Must be treated by a neurologist.
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must be ambulatory (without assistance or support); 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
                                                                                                                                            The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                                                                                                            Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
                                                                                                                                            The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes,