Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p10
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 10/42)
Character Range: 33668–37790

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; and
             (14) 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.
   C6687     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
             Recommencement of treatment
             Patient must have demonstrated treatment response to previous treatment with PBS‑subsidised eculizumab for this condition; AND
             Patient must not have ever experienced treatment failure with eculizumab including PBS‑subsidised eculizumab for this condition; AND
             Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L);OR(iii) TMA‑related organ impairment including on recent biopsy; 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