Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p4
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 4/42)
Character Range: 12774–16698

and should be supported by objective clinical measures. The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.
             Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
             The authority application must be in writing and must include:
             (1) A completed authority prescription form; and
             (2) A completed aHUS eculizumab Authority Application Supporting Information Form ‑ Initial PBS‑subsidised eculizumab 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) The result of ADAMTS‑13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS‑13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS‑13 assay; and
             (8) In the case that a sample for ADAMTS‑13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS‑13 activity must be taken 1‑2 weeks following the last plasma exchange or infusion. The ADAMTS‑13 result must be submitted to the Department of Human Services within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS‑subsidised eculizumab treatment, underInitial treatment 1‑balance of supply; and
             (9) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days; and
             (10) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA‑related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within one month of application; and
             (11) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.
   C6637     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Extended initial treatment ‑ Assessment phase
             Patient must have received treatment under the initial restriction with PBS subsidised eculizumab for this condition; AND
             Patient must have demonstrated on‑going treatment response of PBS‑subsidised eculizumab treatment for this condition; AND
             Patient must not have