Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p332
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 332/476)
Character Range: 2976195–2982632

aHUS;
                                                                                                                                            (b) onset of TMA-related neurological impairment;
                                                                                                                                            (c) onset of TMA-related cardiac impairment;
                                                                                                                                            (d) onset of TMA-related gastrointestinal impairment;
                                                                                                                                            (e) onset of TMA-related pulmonary impairment.
                                                                                                                                            Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), 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 all of the following:
                                                                                                                                            (1) A completed authority prescription form(s);
                                                                                                                                            (2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
                                                                                                                                            (3) A detailed cover letter from the prescriber;
                                                                                                                                            (4) A measurement of body weight at the time of application;
                                                                                                                                            (5) 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 2 weeks prior to collection of the ADAMTS-13 assay;
                                                                                                                                            (6) 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 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;
                                                                                                                                            (7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;
                                                                                                                                            (8) 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 4 weeks of application;
                                                                                                                                            (9) 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.
                                                                                                                                            Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.
                                                                       C14791                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority