Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p18
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 18/42)
Character Range: 62148–66732

neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;
              (9) For all patients, 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.
   C14792     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Initial treatment - Balance of Supply
              Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND
              Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; 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.
              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 27 days of commencement of eculizumab. 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.
   C14793     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Continuing recommencement of treatment
              Patient must have received PBS-subsidised eculizumab under the recommencement of treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing recommencement of treatment phase 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 eculizumab for this condition in the most recent treatment phase; AND
              Patient must not receive more than 24 weeks of treatment with eculizumab per continuing treatment course authorised