Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p309
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 309/476)
Character Range: 2812171–2820325

PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND
                                                                                                                                            Patient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L; OR
                                                                                                                                            Patient must be intolerant to C5 inhibitors as determined by the treating physician; AND
                                                                                                                                            Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND
                                                                                                                                            The treatment must be in combination with one PBS‑subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.
                                                                                                                                            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.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            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 must request the appropriate number of vials for 4 weeks supply per dispensing 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)
                                                                       C13710                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Return from PBS‑subsidised eculizumab post pregnancy or from PBS‑subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy
                                                                                                                                            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 3 (switching from PBS‑subsidised pegcetacoplan for pregnancy (induction doses)' criteria; OR
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with at least one C5 inhibitor and returning to pegcetacoplan treatment for reasons other than post pregnancy; 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 be in combination with one PBS‑subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a non‑specialist medical