Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p22
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 22/42)
Character Range: 76156–80220

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.
   C14805     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Extended Continuing treatment
              Patient must have received PBS-subsidised eculizumab under the continuing treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the extended continuing treatment phase for this condition; AND
              Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
              Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
              Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; OR
              Patient must have severe TMA-related neurological impairment; OR
              Patient must have severe TMA-related gastrointestinal impairment; OR
              Patient must have severe TMA-related pulmonary impairment on current objective measurement; OR
              Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); OR
              Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab; AND
              Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
              Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
              Must 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