Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p95
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 95/476)
Character Range: 1388373–1397197

consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
                                                                                                                                            Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be aged between 6 and 11 years inclusive.
                                                                                                                                            This pharmaceutical benefit is not PBS‑subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
                                                                                                                                            The authority application must be in writing and must include:
                                                                                                                                            (1) a completed authority prescription; and
                                                                                                                                            (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
                                                                                                                                            (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
Eltrombopag                                                            C13327                                                               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.
                                                                       C14126                                                               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