Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p326
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 326/476)
Character Range: 2939346–2946594

subsequent application for treatment.
                                                                                                                                            The authority application must be in writing and must include all of the following:
                                                                                                                                            (1) A completed authority prescription form(s);
                                                                                                                                            (2) 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);
                                                                                                                                            (3) A detailed cover letter from the prescriber;
                                                                                                                                            (4) A measurement of body weight at the time of application;
                                                                                                                                            (5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay;
                                                                                                                                            (6) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days of initiating treatment with non-PBS-subsidised ravulizumab;
                                                                                                                                            (7) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of commencement of non-PBS-subsidised ravulizumab;
                                                                                                                                            (8) For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.
                                                                       C14747                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Extended continuing treatment
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; AND
                                                                                                                                            Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND
                                                                                                                                            Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND
                                                                                                                                            Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; OR
                                                                                                                                            Patient must have severe TMA-related neurological impairment; OR
                                                                                                                                            Patient must have severe TMA-related gastrointestinal impairment; OR
                                                                                                                                            Patient must have severe TMA-related pulmonary impairment on current objective measurement; OR
                                                                                                                                            Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); OR
                                                                                                                                            Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with ravulizumab; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.
                                                                                                                                            Must be treated by a