Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p23
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 23/42)
Character Range: 79940–83679

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 eculizumab 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 eculizumab is severe extra-renal complications that have significantly improved;
              (12) 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.

    [17]       Schedule 3, entry for Lumacaftor with ivacaftor
         substitute:
Lumacaftor with ivacaftor  C14757     Cystic fibrosis                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                      Continuing treatment
                                      Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic