Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p391
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 391/476)
Character Range: 3393517–3411409

C6992               P6992                                            Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6992
                                                                                                                                            Patient must not have cirrhosis; AND
                                                                                                                                            Patient must be nucleoside analogue naive; 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: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                       C6998               P6998                                            HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6998
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naive; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents.
                                                                       C10362              P10362                                           Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required
                                                                                                                                            Patient must be in the third trimester of pregnancy; AND                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              procedures ‑ Streamlined Authority Code 10362
                                                                                                                                            Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat  C4470                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection.
                                                                       C4522                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naive.
Tenofovir with emtricitabine                                           C6985                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6985
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naive; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents.
                                                                       C6986                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6986
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents.
Tenofovir with emtricitabine and efavirenz                             C4470                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection
                                                                       C4522                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve
Tezacaftor with ivacaftor and ivacaftor                                C12609                                                               Cystic fibrosis ‑ one residual function (RF) mutation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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