Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p6
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 6/42)
Character Range: 19453–23297

A family history of aHUS, if applicable; and
             (8) A history of multiple episodes of aHUS before commencing 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.
   C6642     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Initial treatment ‑ Balance of Supply
             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.
             Patient must have received PBS‑subsidised initial supply of eculizumab for this condition; AND
             Patient must have ADAMTS‑13 activity of greater than or equal to 10% on a blood sample; AND
             Patient must not receive more than 20 weeks supply under this restriction.
             ADAMTS‑13 activity result must have been submitted to the Department of Human Services. In the case that a sample for ADAMTS‑13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial Treatment, ADAMTS‑13 activity must have been measured 1‑2 weeks following the last plasma exchange or infusion, and must have been submitted to the Department of Human Services within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS‑13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the two weeks prior to collection of the ADAMTS‑13 assay must also have been provided to Department of Human Services.
             Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
   C6668     Atypical haemolytic