Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p226
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 226/476)
Character Range: 2196721–2207466

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, 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 Continuing Authority Application Supporting Information Form; and
                                                                                                                                            (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
Lamivudine                                                             C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4512                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4993                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4993
                                                                                                                                            Patient must not have cirrhosis, AND
                                                                                                                                            Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
                                                                                                                                            Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND
                                                                                                                                            Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.
                                                                       C5036                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5036
                                                                                                                                            Patient must have cirrhosis, AND
                                                                                                                                            Patient must have detectable HBV DNA.
                                                                                                                                            Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles