Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p91
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 91/476)
Character Range: 1360216–1367680

(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 eculizumab;
                                                                                                                                            (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 eculizumab is severe extra-renal complications that have significantly improved;
                                                                                                                                            (12) 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.
                                                                       C14805                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Extended Continuing treatment
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the continuing treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the extended continuing treatment phase for this condition; AND
                                                                                                                                            Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab 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 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 eculizumab; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised 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.
                                                                                                                                            A treatment response is defined as:
                                                                                                                                            (1) Normalisation of haematology as demonstrated by at least 2 of the following: