Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p98
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 98/476)
Character Range: 1413288–1422311

must not have received treatment with immunosuppressive therapy for this condition; AND
                                                                                                                                            The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND
                                                                                                                                            Patient must be considered ineligible for haemopoietic stem cell transplant; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) 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).
                                                                       C15192                                                               Severe aplastic anaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment - Second line treatment
                                                                                                                                            The condition must be severe aplastic anaemia; AND
                                                                                                                                            Patient must not have achieved an adequate response to prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; OR
                                                                                                                                            Patient must have relapsed following prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; AND
                                                                                                                                            Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                                            The authority application must be made via the online PBS Authorities (real time assessment), or in writing via HPOS form upload or mail and must include:
                                                                                                                                            (a) prior immunosuppressive therapy, including dates of treatment.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) 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).
                                                                       C15482                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
                                                                                                                                            Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
                                                                                                                                            Patient must have at least one F508del mutation in the cystic fibrosis transmembrane conductance (CFTR) gene; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition; AND
                                                                                                                                            Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug.
                                                                                                                                            Patient must be 2 to 5 years of age.
                                                                                                                                            This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
                                                                                                                                            The authority application must be in writing and must include:
                                                                                                                                            (1) details of the proposed prescription; and
                                                                                                                                            (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
                                                                                                                                            (3) details of the pathology report