Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p28
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 28/42)
Character Range: 100107–104034

the patient is receiving treatment) must be provided with every subsequent application for treatment.
              The authority application must be in writing and must include all of the following:
              (1) A completed authority prescription form(s);
              (2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
              (3) A measurement of body weight at the time of application;
              (4) Results of genetic testing, if not previously submitted.
   C14746     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
              Patient must have previously received non-PBS-subsidised therapy with this drug for this condition; AND
              Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS supply was commenced, the patient: (i) had active and progressing thrombotic microangiopathy (TMA) caused by aHUS; (ii) had ADAMTS-13 activity of greater than or equal to 10% on a blood sample not confounded by any plasma exchange or infusion; (iii) had a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days of commencing ravulizumab treatment; (iv) had clinical features of active organ damage or impairment; AND
              Patient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; AND
              Patient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy.
              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.
              Evidence of active and progressing TMA is defined by the following:
              (1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:
              (i) presence of schistocytes on blood film;
              (ii) low or absent haptoglobin;
              (iii) lactate dehydrogenase (LDH) above normal range; or
              (2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and
              (3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
              (a) kidney impairment as demonstrated by one or more of the following:
              (i) a