Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p97
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 97/476)
Character Range: 1404455–1413882

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 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.
                                                                       C15173                                                               Severe aplastic anaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment - Second line treatment
                                                                                                                                            The condition must be severe aplastic anaemia; AND
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND
                                                                                                                                            Patient must have demonstrated a response to PBS-subsidised treatment with this drug.
                                                                                                                                            Platelet, haemoglobin and neutrophil counts must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
                                                                                                                                            Once platelet count is greater than 50 x 109/L, haemoglobin is greater than 100 g/L in the absence of red blood cell (RBC) transfusion, and absolute neutrophil (ANC) is greater than 1 x 109/L for more than 8 weeks, the dose of eltrombopag should be reduced as per the Product Information.
                                                                                                                                            For the purposes of this restriction, a response is defined as no longer meeting the criteria for severe aplastic anaemia.
                                                                       C15174                                                               Severe aplastic anaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - First line treatment
                                                                                                                                            Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND
                                                                                                                                            The condition must be severe aplastic anaemia; AND
                                                                                                                                            Patient must not have received treatment with immunosuppressive therapy for this condition prior to initiating non-PBS-subsidised treatment; AND
                                                                                                                                            The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND
                                                                                                                                            Patient must be considered ineligible for haemopoietic stem cell transplant; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.
                                                                                                                                            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).
                                                                                                                                            A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                       C15191                                                               Severe aplastic anaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            First line treatment
                                                                                                                                            The condition must be severe aplastic anaemia; AND
                                                                                                                                            Patient must not have received treatment with immunosuppressive therapy for this condition; AND
                                                                                                                                            The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND
                                                                                                                                            Patient must be considered ineligible for haemopoietic stem cell transplant; AND