Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p328
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 328/476)
Character Range: 2951917–2958271

A history of multiple episodes of aHUS before commencing ravulizumab treatment, if applicable;
                                                                                                                                            (7) A history of kidney transplant, if applicable (especially if required due to aHUS);
                                                                                                                                            (8) An inclusion of the individual consequences of recurrent disease;
                                                                                                                                            (9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;
                                                                                                                                            (10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;
                                                                                                                                            (11) 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 ravulizumab is severe extra-renal complications that have significantly improved;
                                                                                                                                            (12) If the indication for continuing ravulizumab 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 ravulizumab.
                                                                       C14748                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Balance of Supply - maintenance doses
                                                                                                                                            Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; AND
                                                                                                                                            Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
                                                                                                                                            Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase.
                                                                                                                                            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.
                                                                                                                                            This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
                                                                                                                                            ADAMTS-13 activity result must have been submitted to Services Australia. 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 7-10 days following the last plasma exchange or infusion and must have been submitted to