Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p329
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 329/476)
Character Range: 2958020–2964735

activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.
                                                                                                                                            Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
                                                                       C14749                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the initial treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised ravulizumab under the grandfather restriction for this condition; AND
                                                                                                                                            Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab 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 not receive more than 72 weeks of ravulizumab 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 with ravulizumab 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 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 defined as:
                                                                                                                                            (1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
                                                                                                                                            (2) One of the following:
                                                                                                                                            a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
                                                                                                                                            b) an eGFR within +/- 25% from baseline; or
                                                                                                                                            c) an avoidance of dialysis-dependence but worsening of kidney