Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p333
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 333/476)
Character Range: 2981413–2988150

for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.
                                                                       C14791                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Recommencement of treatment
                                                                                                                                            Patient must have demonstrated treatment response to previous treatment with a PBS-subsidised C5 inhibitor 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 have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy.
                                                                                                                                            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 function with a reduction in eGFR 25% from baseline.
                                                                                                                                            PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab 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 receiving treatment).
                                                                                                                                            The authority