Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p77
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 77/476)
Character Range: 1264512–1272420

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 multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
                                                                                                                                            Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; 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).
                                                                                                                                            At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
                                                                                                                                            (i) Haemoglobin (g/L)
                                                                                                                                            (ii) Platelets (x109/L)
                                                                                                                                            (iii) White Cell Count (x109/L)
                                                                                                                                            (iv) Reticulocytes (x109/L)
                                                                                                                                            (v) Neutrophils (x109/L)
                                                                                                                                            (vi) Granulocyte clone size (%)
                                                                                                                                            (vii) Lactate Dehydrogenase (LDH)
                                                                                                                                            (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
                                                                                                                                            (ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5
                                                                       C13560                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ initial 1 (new patient) induction doses
                                                                                                                                            Patient must not have received prior treatment with this drug for this condition; AND
                                                                                                                                            Patient must have a diagnosis of PNH established by flow cytometry; AND
                                                                                                                                            Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND
                                                                                                                                            Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND
                                                                                                                                            Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR
                                                                                                                                            Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR
                                                                                                                                            Patient must have chronic/recurrent anaemia, where causes other than