Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p76
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 76/476)
Character Range: 1256616–1264939

and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS‑subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.
                                                                       C13459                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Return from PBS‑subsidised pegcetacoplan ‑ induction doses
                                                                                                                                            Patient must have received PBS‑subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND
                                                                                                                                            Patient must have received PBS‑subsidised treatment with pegcetacoplan for this condition; AND
                                                                                                                                            Patient must have developed resistance or intolerance to pegcetacoplan; AND
                                                                                                                                            The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (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).
                                                                                                                                            For continuing PBS‑subsidised treatment with this drug, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria.
                                                                       C13464                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Grandfather 1 (transition from non‑PBS‑subsidised treatment) ‑ maintenance phase
                                                                                                                                            Patient must have received non‑PBS‑subsidised eculizumab for this condition prior to 1 March 2022; AND
                                                                                                                                            Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
                                                                                                                                            Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
                                                                                                                                            Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
                                                                                                                                            Patient must have experienced clinical improvement as a result of treatment with this drug; OR
                                                                                                                                            Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
                                                                                                                                            Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with