Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p310
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 310/476)
Character Range: 2819665–2827968

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 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)
                                                                                                                                            For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long‑term continuing PBS‑subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan.
                                                                       C13743                                                               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 'Return' 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 a Complement 5 (C5) inhibitor.
                                                                                                                                            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