Monitoring and treatment of inactive chronic hepatitis B: Is it cost‐effective?

I n this issue of HEPATOLOGY, an interesting article by Toy et al. addresses the clinical effect and costeffectiveness of managing inactive chronic hepatitis B (CHB) carriers. Current clinical practice in China for hepatitis B virus (HBV) is prevention by vaccinating all infants and children against hepatitis B. In fact, this is a common practice in most of the developing and emerging countries, especially Africa and parts of eastern Asia. However, according to the researchers, despite a universal vaccination policy against hepatitis B in China, hepatitis B remains a major health threat to the general population. Using computer simulation and Markov modeling, the researchers assessed the cost-effectiveness of a strategy of lifelong monitoring for inactive CHB and treatment of eligible patients in Shanghai, China. In comparison with the current clinical practice in Shanghai, the strategy of “monitor and treat” was shown to be cost-effective with an incremental cost-effectiveness ratio (ICER) of $2,996 per quality-adjusted life-years (QALY) gained. In this analysis, ICER of monitor and treat clearly meets the threshold of <$50,000 per QALY that is the generally accepted threshold for cost-effectiveness. Furthermore, the result of the sensitivity analyses performed by the researchers provided additional interesting insights. In these analyses, the researchers found that by increasing the percentage of population tested and by increasing the rate of adherence to the treatment regimen, ICER will continue to improve. Moreover, the most important assumption that was identified in the sensitivity analyses was the cost of entecavir. If this cost (assumed for the base case to be $1,869) was reduced by 50% ($964), the monitor and treat strategy would actually become cost-saving. The researchers should be congratulated for carefully addressing an important issue in the management of inactive CHB, which could potentially have some global implications. The analytic methodology used in this study is generally sound and carried out with rigor. A few weaknesses that need to be considered are the generalizability of the transition rates, cost, and utility assumptions. For example, viral suppression was assumed to have a utility of 1.0, which defines perfect health. In reality, the extreme of utility scores (0 to 1) in the general population is hardly attainable and thus provides the reader with an overestimation of the health status associated with viral suppression. Nevertheless, this and other assumptions related to transition rates do not seem to have an important effect on the final ICER. As noted previously, of the assumptions tested in the sensitivity analyses, only the cost of entecavir was shown to significantly influence ICER. It is important to note that the cost of entecavir used in the base-case scenario or sensitivity analyses may not be generalized to the other areas of the world. Also, the researchers did not consider the cost of other important anti-HBV drugs, such as tenofovir, which are also highly effective and widely used to treat HBV. This, again, raises some potential issues with the external validity of their data. Another important limitation of this study was their goal of showing the benefit of the monitor and treat strategy at the population level. As noted by the researchers, achieving gains at the population level would require identification of more cases of CHB and appropriate treatment and management of these patients. Also, the ability to generalize this strategy beyond Shanghai, China, would require that the assumptions be validated using data from other parts of China and the world. Nevertheless, the rates used by Toy et al. seem to be consistent with what researchers have recently reported from other areas of the world. In one study, Ott et al., as part of the Global Burden of Diseases, Injuries and Risk Factor Study, investigated the global epidemiology of HBV and provided age-specific hepatitis B surface antigen (HBsAg) seroprevalence rates. A reduction in HBV prevalence Abbreviations: CHB, chronic hepatitis B; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HRQL, health-related quality of life; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-years. Received January 10, 2014; accepted February 4, 2014. Address reprint requests to: Zobair M. Younossi, M.D., M.P.H. , Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research Building, 3300 Gallows Road, Falls Church, VA 22042. E-mail: zobair.younossi@inova.org; fax: 703-776-4386. Copyright VC 2014 by the American Association for the Study of Liver Diseases. View this article online at wileyonlinelibrary.com. DOI 10.1002/hep.27062 Potential conflict of interest: Nothing to report.