Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p85
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 85/476)
Character Range: 1323513–1330345

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 measurement of body weight at the time of application;
                                                                                                                                            (4) Results of genetic testing, if not previously submitted;
                                                                                                                                            (5) A family history of aHUS, if applicable;
                                                                                                                                            (6) A history of kidney transplant if applicable (especially if required due to aHUS);
                                                                                                                                            (7) An inclusion of the individual consequences of recurrent disease, if applicable;
                                                                                                                                            (8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
                                                                                                                                            (9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;
                                                                                                                                            (10) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
                                                                                                                                            This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.
                                                                       C14781                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND
                                                                                                                                            Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
                                                                                                                                            Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
                                                                                                                                            Patient must have clinical features of active organ damage or impairment; AND
                                                                                                                                            Patient must not receive more than 4 weeks of treatment under this restriction.
                                                                                                                                            Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
                                                                                                                                            Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
                                                                                                                                            Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
                                                                                                                                            Evidence of active and progressing TMA is defined by the following:
                                                                                                                                            (1) a platelet