Document ID: chunk:federal_register_of_legislation:F2023L01745:schedule:1:p25
Version: federal_register_of_legislation:F2023L01745
Segment Type: schedule
Provision Reference: sch 1 (pt 25/42)
Character Range: 87358–91983

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.
                           C14783     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 be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (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; AND
                                      The treatment must be the sole PBS-subsidised cystic 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