Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p32
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 32/42)
Character Range: 113554–118160

undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.
   C14748     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Balance of Supply - maintenance doses
              Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; AND
              Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
              Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; AND
              The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase.
              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.
              ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.
              Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
   C14749     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Continuing treatment
              Patient must have received PBS-subsidised ravulizumab under the initial 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 grandfather restriction 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 not receive more than 72 weeks of ravulizumab treatment in total under this restriction; OR
              Patient must not receive