Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p31
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 31/42)
Character Range: 110503–114543

of kidney function with a reduction in eGFR 25% from baseline.
              PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
              A treatment failure is defined as a patient who is:
              (1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
              (2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
              The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving 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 measurement of body weight at the time of application;
              (4) Results of genetic testing, if not previously submitted;
              (5) A family history of aHUS, if applicable;
              (6) 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