Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p324
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 324/476)
Character Range: 2926788–2933742

treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Continuing recommencement of 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 2 weeks of treatment 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.
                                                                                                                                            This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
                                                                                                                                            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.
                                                                       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