Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p11
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 11/42)
Character Range: 37462–41648

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:
             (1) A completed authority prescription form(s); and
             (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Recommencement of treatment; and
             (3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
             (4) A detailed cover letter from the prescriber; and
             (5) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and
             (6) A measurement of body weight at the time of application, and
             (7) An identified genetic mutation, if applicable; and
             (8) A family history of aHUS if applicable; and
             (9) A history of multiple episodes of aHUS following the treatment break, if applicable; and
             (10) A history of kidney transplant if applicable (especially if required due to aHUS); and
             (11) An inclusion of the individual consequences of recurrent disease; and
             (12) 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;
             (13) Evidence that the patient has had a treatment response to their previous treatment with eculizumab; and
             (14) 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
             (15) 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.
   C6688     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Continuing recommencement of treatment
             Patient must have received treatment under Recommencement of treatment restriction with PBS‑subsidised eculizumab for this condition; AND
             Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS‑subsidised eculizumab for this condition; AND
             Patient must not have experienced treatment failure with eculizumab including PBS‑subsidised eculizumab for this condition; AND
             Patient must not receive more than 24 weeks of treatment under this restriction.
             Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist