Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p80
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 80/476)
Character Range: 1285138–1295367

(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
                                                                       C13661                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Subsequent Continuing Treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; 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
                                                                                                                                            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).
                                                                       C13684                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (switching from PBS‑subsidised ravulizumab for pregnancy)
                                                                                                                                            Patient must be planning pregnancy; OR
                                                                                                                                            Patient must be pregnant; AND
                                                                                                                                            Patient must have received PBS‑subsidised treatment with ravulizumab for this condition; 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).
                                                                                                                                            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.
                                                                       C13845                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            First Continuing Treatment
                                                                                                                                            Patient must have received PBS‑subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; 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