Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p245
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 245/476)
Character Range: 2351255–2359876

fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
                                                                                                                                            Patient must be aged between 6 and 11 years inclusive.
                                                                                                                                            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 being homozygous for the F508del mutation on the CFTR gene - 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.
                                                                       C14784                                                               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 the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be aged between 6 and 11 years inclusive.
                                                                                                                                            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.
                                                                       C14785                                                               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; AND
                                                                                                                                            The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy