Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p100
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 100/476)
Character Range: 1434227–1446322

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 per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
                                                                       C5037                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5037
                                                                                                                                            Patient must have cirrhosis, AND
                                                                                                                                            Patient must have failed lamivudine, 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.
                                                                       C5044                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5044
                                                                                                                                            Patient must not have cirrhosis, AND
                                                                                                                                            Patient must have failed lamivudine, 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.
Epoetin Alfa                                                           C6294                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
                                                                       C9688                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
Epoetin Beta                                                           C6294                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
                                                                       C9688                                                                Anaemia associated with intrinsic