Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p177
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 177/191)
Character Range: 11271993–11282917

of treatment is not considered as a treatment failure.
                                                                                                                                                                                                                               A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                                                                                                                               Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                                                                                                                               At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.
                                                                                                                                                                                                                               Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend continuing treatment beyond 24 months.
C9688               P9688          CN9688           Darbepoetin alfa                                                                                                                                                           Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9688
                                                                                                                                                                                                                               Patient must require transfusion; AND
                                                    Epoetin alfa                                                                                                                                                               Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                                                                                                               Patient must have intrinsic renal disease, as assessed by a nephrologist.
                                                    Epoetin beta

                                                    Epoetin lambda

                                                    Methoxy polyethylene glycol-epoetin beta

C9689               P9689          CN9689           Mycophenolic acid                                                                                                                                                          Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 9689
                                                                                                                                                                                                                               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.
C9690               P9690          CN9690           Mycophenolic acid                                                                                                                                                          Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9690
                                                                                                                                                                                                                               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.
C9691               P9691          CN9691           Everolimus                                                                                                                                                                 Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 9691
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                    Mycophenolic acid                                                                                                                                                          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.
C9692               P9692          CN9692           Mycophenolic acid                                                                                                                                                          Prophylaxis of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9692
                                                                                                                                                                                                                               Management
                                                                                                                                                                                                                               The treatment