Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p5
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 5/42)
Character Range: 16365–19739

treatment ‑ Assessment phase
             Patient must have received treatment under the 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 56 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.
             A maximum of up to 56 weeks of treatment is allowed under this restriction, however an application must be submitted at 6 months, 12 months, 18 months and 24 months following commencing PBS‑subsidised eculizumab.
             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 Extended Initial 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 commencing eculizumab treatment, if applicable; and
             (9) A history of kidney transplant, if applicable, (especially if required due to aHUS); and
             (10) An