Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p94
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 94/476)
Character Range: 1380227–1388772

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 at least 6 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) a completed authority prescription; and
                                                                                                                                            (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
                                                                                                                                            (3) details of the pathology report substantiating the patient having at least one F508del mutation ‑ quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
                                                                                                                                            (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
                                                                       C13980                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Continuing 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 previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be at least 6 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) a completed authority prescription; and
                                                                                                                                            (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
                                                                                                                                            (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
                                                                       C13991                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Continuing 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