Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p354
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 354/476)
Character Range: 3134082–3141981

The treatment must be in combination with other antiretroviral agents
Romiplostim                                                            C13396                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Second or Subsequent Continuing treatment
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
                                                                                                                                            Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
                                                                                                                                            The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
                                                                                                                                            The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
                                                                                                                                            Authority approval will not be given for doses higher than 10 micrograms/kg/week
                                                                       C14098                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ New patient
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
                                                                                                                                            Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
                                                                                                                                            The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
                                                                                                                                            (a) a platelet count of less than or equal to 20,000 million per L; OR
                                                                                                                                            (b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
                                                                                                                                            The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.
                                                                                                                                            Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.
                                                                                                                                            Authority approval will not be given for doses higher than 10 micrograms/kg/week
                                                                                                                                            The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
                                                                                                                                            (a) details of a platelet count supporting the diagnosis of