Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p307
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 307/476)
Character Range: 2794007–2803546

be hereditary transthyretin amyloidosis confirmed by genetic testing; AND
                                                                                                                                            Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; OR
                                                                                                                                            Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND
                                                                                                                                            Patient must not have previously undergone a liver transplant; AND
                                                                                                                                            Patient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV).
                                                                                                                                            Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND
                                                                                                                                            Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).
                                                                                                                                            PND scores in the context of this PBS restriction are:
                                                                                                                                            Stage 0 - No symptoms;
                                                                                                                                            Stage I - Sensory disturbances but preserved walking capability;
                                                                                                                                            Stage II - Impaired walking capacity but able to walk without stick or crutches;
                                                                                                                                            Stage IIIA - Walking with help of one stick or crutch;
                                                                                                                                            Stage IIIB - Walking with help of two sticks or crutches;
                                                                                                                                            Stage IV - Confined to wheelchair or bedridden.
                                                                                                                                            FAP stage in the context of this PBS restriction are:
                                                                                                                                            Stage 0 - No symptoms;
                                                                                                                                            Stage 1 - Unimpaired ambulation;
                                                                                                                                            Stage 2 - Assistance with ambulation required;
                                                                                                                                            Stage 3 - Wheelchair-bound or bedridden.
                                                                                                                                            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).
                                                                       C15478                                                               Hereditary transthyretin amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                                            Patient must have received treatment with this drug for this condition prior to 1 August 2024; 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).
                                                                       C15501                                                               Hereditary transthyretin amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with