Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p14
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 14/42)
Character Range: 48951–52931

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 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.
              The application must indicate the most recent treatment phase that the patient is switching from.
              For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.
              Serial haematological results (every 3 months while 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.
   C14754     Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
              Continuing treatment
              Patient must have received PBS-subsidised eculizumab under the initial treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the initial treatment phase for this condition; OR
              Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; AND
              Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab 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 80 weeks of eculizumab treatment in total under this restriction; OR
              Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND
              Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised 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