Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p334
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 334/476)
Character Range: 2987561–2994942

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 following the treatment break, 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;
                                                                                                                                            (9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
                                                                                                                                            (10) Evidence that the patient has had a treatment response to their previous treatment with a C5 inhibitor;
                                                                                                                                            (11) 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 ravulizumab is severe extra-renal complications that have significantly improved;
                                                                                                                                            (12) If the indication for continuing ravulizumab 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.
                                                                                                                                            Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.
                                                                       C14797                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Continuing recommencement of treatment
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Recommencement treatment' restriction for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Continuing recommencement treatment' restriction for this condition; AND
                                                                                                                                            Patient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor 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 not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.
                                                                                                                                            Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist;