Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p96
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 96/476)
Character Range: 1396537–1404857

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.
                                                                       C14127                                                               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
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
                                                                                                                                            Patient must be changing therapy from romiplostim or avatrombopag to this drug for this condition; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
                                                                                                                                            Patients receiving treatment with romiplostim or avatrombopag may change to eltrombopag under this restriction.
                                                                       C14129                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            First Continuing treatment or Re‑initiation of interrupted continuing treatment
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            Patient must have demonstrated a sustained platelet response to PBS‑subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
                                                                                                                                            Patient must have changed treatment from either romiplostim or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; OR
                                                                                                                                            Patient must have demonstrated a sustained platelet response to the most recent PBS‑subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
                                                                                                                                            For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
                                                                                                                                            The platelet count must be conducted no later