Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p395
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 395/476)
Character Range: 3431626–3441667

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 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.
Thalidomide                                                            C5914                                                                Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 5914
                                                                       C9290                                                                Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9290
Tocilizumab                                                            C9380                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Continuing Treatment ‑ balance of supply
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
                                                                       C9386                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 16 weeks treatment available