Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p308
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 308/476)
Character Range: 2801964–2812543

relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C15501                                                               Hereditary transthyretin amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must continue to demonstrate clinical benefit; AND
                                                                                                                                            Patient must not be permanently bedridden; OR
                                                                                                                                            Patient must not be receiving end-of-life care.
                                                                                                                                            Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (a) details of the proposed prescription; and
                                                                                                                                            (b) 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).
Pegcetacoplan                                                          C13616                                                               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 the 'Initial' or 'Grandfather' treatment restriction; 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 dispensing as per the Product Information. A maximum of 5 repeats may be requested.
                                                                                                                                            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)
                                                                       C13655                                                               Paroxysmal nocturnal haemoglobinuria (PNH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment (new patient)
                                                                                                                                            Patient must not have received prior treatment with this drug for this condition; AND
                                                                                                                                            Patient must have 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