Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p390
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 390/476)
Character Range: 3383908–3395123

age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.
                                                                                                                                            Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form(s); and
                                                                                                                                            (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Tenofovir                                                              C6980               P6980                                            Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6980
                                                                                                                                            Patient must have cirrhosis; AND
                                                                                                                                            Patient must be nucleoside analogue naive; AND
                                                                                                                                            Patient must have detectable HBV DNA; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                                            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 per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
                                                                       C6982               P6982                                            HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6982
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents.
                                                                       C6983               P6983                                            Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6983
                                                                                                                                            Patient must have cirrhosis; AND
                                                                                                                                            Patient must have failed antihepadnaviral therapy; 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 per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
                                                                       C6984               P6984                                            Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6984
                                                                                                                                            Patient must not have cirrhosis; AND
                                                                                                                                            Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                            Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
                                                                                                                                            Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.
                                                                       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