Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p8
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 8/42)
Character Range: 26842–30942

of application; and
             (6) An identified genetic mutation, if applicable; and
             (7) A family history of aHUS, if applicable; and
             (8) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and
             (9) A history of kidney transplant if applicable (especially if required due to aHUS); and
             (10) An inclusion of the individual consequences of recurrent disease, if applicable; and
             (11) 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; and
             (12) 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; and
             (13) 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.
   C6686     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Extended Continuing treatment
             Patient must have received treatment under the Continuing treatment with PBS‑subsidised eculizumab for this condition; AND
             Patient must have demonstrated on‑going treatment response with PBS‑subsidised eculizumab for this condition; AND
             Patient must not have ever experienced treatment failure with eculizumab including PBS‑subsidised eculizumab for this condition; 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 paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
             A treatment response is defined as:
             (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
             (2) One of the