Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p31
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 31/476)
Character Range: 887816–896337

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.
                                                                       C14130                                                               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 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 ITP.
                                                                                                                                            All reports must be documented in the patient's medical records.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            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.
                                                                                                                                            A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
                                                                       C15340                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Balance of supply or change of therapy
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR