Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p374
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 374/476)
Character Range: 3269428–3280272

a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist; AND
                                                                                                                                            Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; OR
                                                                                                                                            Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
                                                                                                                                            Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.
                                                                       C12594                                                               Idiopathic multicentric Castleman disease (iMCD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                            Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum.
Sirolimus                                                              C5795                                                                Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 5795
                                                                                                                                            Management (initiation, stabilisation and review of therapy)
                                                                                                                                            Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
                                                                                                                                            The treatment must be under the supervision and direction of a transplant unit.
                                                                       C9914                                                                Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 9914
                                                                                                                                            Management (initiation, stabilisation and review of therapy)
                                                                                                                                            Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
                                                                                                                                            The treatment must be under the supervision and direction of a transplant unit.
Sofosbuvir with velpatasvir                                            C5969                                                                Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                            Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 12 weeks.
Sofosbuvir with velpatasvir and voxilaprevir                           C10248                                                               Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                            Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                            The treatment must be