Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p323
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 323/476)
Character Range: 2918305–2927399

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, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information
                                                                                                                                            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
                                                                       C14586                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Return from PBS‑subsidised eculizumab ‑ induction dose
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with eculizumab through the 'Initial treatment ‑ Initial 2 (switching from PBS‑subsidised ravulizumab for pregnancy)' 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 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, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information
                                                                                                                                            Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long‑term continuing PBS‑subsidised treatment with this drug is planned, a 'Returning' patient may proceed under the 'Subsequent Continuing Treatment' criteria.
                                                                       C14744                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Switch from PBS-subsidised eculizumab (all phases) - loading dose
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Initial treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Continuing treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Extended continuing treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Continuing recommencement of treatment' restriction for this condition;