Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p394
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 394/476)
Character Range: 3424966–3432278

100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
                                                                                                                                            Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
                                                                                                                                            Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
                                                                                                                                            Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
                                                                                                                                            Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
                                                                                                                                            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 RF 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) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
                                                                       C12635                                                               Cystic fibrosis ‑ homozygous for the F508del mutation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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 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; AND
                                                                                                                                            Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
                                                                                                                                            Patient must be 12 years of age or older.
                                                                                                                                            Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
                                                                                                                                            Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
                                                                                                                                            Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
                                                                                                                                            Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital,