Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p15
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 15/42)
Character Range: 52659–55884

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.
              A treatment response is defined as:
              (1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
              (2) One of the following:
              a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
              b) an eGFR within +/- 25% from baseline; or
              c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
              PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab 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 kidney transplant if applicable (especially if required due to aHUS);
              (7) An inclusion of the individual consequences of recurrent disease, if applicable;
              (8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
              (9) 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;