Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p13
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 13/42)
Character Range: 44361–49202

the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and
             (12) 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 eculizumab is severe extra‑renal complications that have significantly improved; and
             (13) 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.

       (b)           insert in numerical order after existing text:
   C14750     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Recommencement - Balance of Supply
              Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; AND
              Patient must not receive more than 20 weeks supply 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.
              Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
   C14753     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Switch from PBS-subsidised ravulizumab (all phases) - loading dose
              Patient must have previously received PBS-subsidised ravulizumab under the 'Initial treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised ravulizumab under the 'Extended continuing treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing recommencement of treatment' restriction for this condition; OR
              Patient must have previously received PBS-subsidised ravulizumab under the 'Grandfather (transitioning from non-PBS to PBS-subsidised treatment)' restriction for this condition; AND
              Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
              Patient must not receive more than 24 weeks of C5 inhibitor supply for this current treatment phase under this restriction.
              Must be treated by a prescriber who