Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p82
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 82/476)
Character Range: 1302273–1311393

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, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, 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)
                                                                       C14750                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Recommencement - Balance of Supply
                                                                                                                                            Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; AND
                                                                                                                                            Patient must not receive more than 20 weeks supply under this restriction.
                                                                                                                                            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.
                                                                                                                                            Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
                                                                       C14753                                                               Atypical haemolytic uraemic syndrome (aHUS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Switch from PBS-subsidised ravulizumab (all phases) - loading dose
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab under the 'Initial treatment' restriction for this condition; OR
                                                                                                                                            Patient must have previously received PBS-subsidised ravulizumab