Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p36
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 36/42)
Character Range: 127418–131191

or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;
              (6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;
              (7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;
              (8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related 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.
              Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.
   C14791     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Recommencement of treatment
              Patient must have demonstrated treatment response to previous treatment with a PBS-subsidised 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 have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy.
              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