Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p38
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 38/42)
Character Range: 133916–137962

treatment with a C5 inhibitor;
              (11) Evidence 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 ravulizumab is severe extra-renal complications that have significantly improved;
              (12) If the indication for continuing ravulizumab 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.
              Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.
   C14797     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Continuing recommencement of treatment
              Patient must have received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
              Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Recommencement treatment' restriction for this condition; OR
              Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Continuing recommencement treatment' restriction for this condition; AND
              Patient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor 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 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 this application is sought.
              A treatment failure is defined as