Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p223
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 223/476)
Character Range: 2177456–2184250

(150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.
                                                                                                                                            Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.
                                                                                                                                            Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
                                                                                                                                            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 G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (i) the specific CFTR mutation listed in the TGA approved Product Information, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient, and
                                                                                                                                            (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
                                                                       C15252                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment (gating mutations)
                                                                                                                                            Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
                                                                                                                                            Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be aged 4 months or older.
                                                                                                                                            Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole,