Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p7
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 7/42)
Character Range: 22999–27145

to collection of the ADAMTS‑13 assay must also have been provided to Department of Human Services.
             Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
   C6668     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Continuing treatment
             Patient must have received treatment under Extended Initial restriction with PBS subsidised eculizumab for this condition; AND
             Patient must have demonstrated on‑going treatment response of PBS‑subsidised eculizumab treatment for this condition; AND
             Patient must not have experienced treatment failure with eculizumab including PBS‑subsidised eculizumab for this condition; AND
             Patient must not receive more than 24 weeks of treatment under this restriction.
             Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
             A treatment response is defined as:
             (1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and 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 eculizumab 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.
             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 PBS‑subsidised eculizumab 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:
             (1) A completed authority prescription form; and
             (2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
             (3) A detailed cover letter from the prescriber; and
             (4) A copy of a current Certificate of vaccination or a statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed; and
             (5) A measurement of body weight at the time of application; and
             (6) An identified genetic mutation, if applicable; and
             (7) A family history of aHUS, if applicable; and
             (8) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and
             (9) A history of kidney