Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p88
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 88/476)
Character Range: 1341352–1348438

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.
                                                                       C14793                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Continuing recommencement of treatment
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the recommencement of treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; OR
                                                                                                                                            Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing recommencement of treatment phase for this condition; AND
                                                                                                                                            Patient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor 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 24 weeks of treatment with eculizumab 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.
                                                                                                                                            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 function with a reduction in eGFR 25% from baseline.
                                                                                                                                            PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
                                                                                                                                            A treatment failure is defined as a patient who is:
                                                                                                                                            (1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
                                                                                                                                            (2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
                                                                                                                                            The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is