Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p16
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 16/42)
Character Range: 55568–59474

of application;
              (9) 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;
              (10) 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.
   C14781     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Initial treatment
              Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND
              Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
              Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
              Patient must have clinical features of active organ damage or impairment; AND
              Patient must not receive more than 4 weeks of treatment 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.
              Evidence of active and progressing TMA is defined by the following:
              (1) a platelet count of less than 150x10^9/L; and evidence of two of the following:
              (i) presence of schistocytes on blood film;
              (ii) low or absent haptoglobin;
              (iii) lactate dehydrogenase (LDH) above normal range;
              OR
              (2) in recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA;
              AND
              (3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
              (a) kidney impairment as demonstrated by one of the following:
              (i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
              (ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no