The doses of 10μg should replace the doses of 5μg in newborn hepatitis B vaccination in China: A cost-effectiveness analysis

Objective: To identify whether Chinese current series of three 5 μg doses for newborn hepatitis B vaccination should be replaced by the series of three 10 μg doses. Methods: A cost-effectiveness analysis was conducted from the societal perspective based on the constructed decision tree-Markov model. Model parameters were estimated from published literatures, government documents and our surveys. The expected cost and effectiveness were compared between the 3-dose 5 μg series (the 5 μg strategy) and the 3-dose 10 μg series (the 10 μg strategy), and the incremental cost-effectiveness ratio (ICER, additional cost per quality-adjusted life-years gained) was calculated. Threshold values of the efficacy difference of the two series for the ICER = 0, 1 and 3 times per capita gross domestic product were analyzed under different scenarios to understand whether the 10 μg strategy should replace the 5 μg strategy according to the recommendation of World Health Organization. Results: The 10 μg strategy would be cost-saving compared with the 5 μg strategy under the base-case scenario. Under keeping all the other parameters at the base-case values or further adjusting any one of them to the value most unfavorable to the 10 μg strategy, as long as the efficacy of 3-dose 10 μg series was slightly higher than that of 3-dose 5 μg series, the 10 μg strategy would be cost-effective, highly cost-effective, or even cost-saving. Even under the most pessimistic scenario, i.e. all the other parameters, but the discount rate, at the values most unfavorable to the 10 μg strategy, the 10 μg strategy would be cost-effective if the efficacy difference reached higher than 1.23 percentage point. Conclusion: For newborn hepatitis B vaccination in China, the 10 μg strategy should be cost-effective, even more possibly highly cost-effective or cost-saving compared with the current 5 μg strategy. The doses of 10 μg should be considered to replace the doses of 5 μg in newborn hepatitis B vaccination in China.