Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p30
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 30/42)
Character Range: 106791–110777

For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.
   C14747     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Extended continuing treatment
              Patient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; OR
              Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; OR
              Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; AND
              Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND
              Patient must not have experienced treatment failure with ravulizumab 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 ravulizumab; AND
              Patient must not receive more than 24 weeks of treatment with ravulizumab 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.
              This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
              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 ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where