Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p113
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 113/476)
Character Range: 1523548–1535370

response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 12 months 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.
                                                                                                                                            If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
Etravirine                                                             C5014                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5014
                                                                                                                                            The treatment must be in addition to optimised background therapy, AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents, AND
                                                                                                                                            Patient must be antiretroviral experienced, AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
Everolimus                                                             C5554                                                                Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 5554
                                                                                                                                            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.
                                                                       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.
                                                                       C9691                                                                Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 9691
                                                                                                                                            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.
                                                                       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.
Filgrastim                                                             C6621                                                                Severe chronic neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 6621
                                                                                                                                            Patient must have an