Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p355
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 355/476)
Character Range: 3141453–3149570

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 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.
                                                                       C14099                                                               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 eltrombopag 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 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
                                                                                                                                            The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS‑subsidised course of treatment with this drug and must be documented in the patient's medical records.
                                                                       C14149                                                               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