A Markov model cost threshold analysis of potential hepatitis B virus cure regimens

INTRODUCTION: Novel treatment regimens to achieve functional cure (FC) of chronic hepatitis B (CHB) may soon be available. We aimed to evaluate treatment cost-effectiveness thresholds for a potential cure regimen in the U.S. and China using a Markov model, with long-term nucleos(t)ide analogue (NUC) treatment as reference. METHODS: We simulated disease progression comparing achieving FC defined as HBsAg loss and unquantifiable HBV DNA 24 weeks off treatment with a novel therapeutic regimen to long-term NUC treatment. Cost-effectiveness thresholds for FC of CHB, incorporating various anticipated success rates for FC, incidence rates of major liver outcomes including hepatocellular carcinoma post-FC, health utility values, and medical costs, were estimated. RESULTS: The base case was a 50-year-old man with hepatitis B e antigen (HBeAg)-negative non-cirrhotic CHB and NUC-suppressed HBV DNA ≥1year. Compared to long-term NUC, a 30% effective FC regimen would yield 17.18 and 16.14 quality-adjusted life years (QALYs), and 0.30 and 0.57 QALYs gained per patient in the U.S. and China, respectively. With an HCC annual incidence rate of 0.1% after FC, a FC regimen could be cost-effective at a one-time treatment cost under the threshold of USD46,642 in the U.S., and USD13,008 in China. The cost-effectiveness threshold increases with higher FC rates, younger patients, and increasing medical costs, but may be lower in women. DISCUSSION: A Markov model-based cost-effectiveness analysis demonstrates that CHB cure regimen with 30% FC in aforementioned base case could be cost-effective at a threshold of USD46,642 in the U.S. and USD13,008 in China.