Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p89
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 89/476)
Character Range: 1348007–1354757

and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
                                                                                                                                            The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving 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 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 multiple episodes of aHUS before recommencing eculizumab treatment, if applicable;
                                                                                                                                            (7) A history of kidney transplant if applicable (especially if required due to aHUS);
                                                                                                                                            (8) An inclusion of the individual consequences of recurrent disease, if applicable;
                                                                                                                                            (9) 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;
                                                                                                                                            (10) 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;
                                                                                                                                            (11) 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.
                                                                       C14799                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Recommencement of treatment
                                                                                                                                            Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; AND
                                                                                                                                            Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
                                                                                                                                            Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND