Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p83
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 83/476)
Character Range: 1309800–1318620

syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Switch from PBS-subsidised ravulizumab (all phases) - loading dose
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Initial treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Extended continuing treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing recommencement of treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Grandfather (transitioning from non-PBS to PBS-subsidised treatment)' restriction for this condition; AND
                                                                                                                                            Patient must have/had ADAMTS-13 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