Economic evaluation of including the EV71 vaccine in the national immunization program: a modeling study in Guangxi, China

Background: Hand, foot, and mouth disease (HFMD) remains a major public health concern among children in China, particularly in those under 5 years of age. Enterovirus 71 (EV71) is the leading cause of severe cases and mortality. Although EV71 vaccines are highly effective, they are currently self-paid in China, and evidence on publicly funded strategies remains limited. This study evaluated the health and economic impact of including the EV71 vaccine in the National Immunization Program (NIP) in Guangxi from a societal perspective, incorporating both direct medical costs and indirect productivity losses. Methods: A decision tree-Markov model simulated a cohort of 420,000 newborns over a 5-year horizon. Two strategies were compared: NIP inclusion (free vaccination) and the current self-paid approach. Cost-effectiveness and cost-benefit analyses were conducted, with outcomes including incremental cost-effectiveness ratio (ICER) and benefit-cost ratio (BCR). Sensitivity analyses were performed to assess uncertainty. Results: Compared with the self-paid strategy, NIP inclusion increased vaccination by 344,190 individuals and prevented 14,234 HFMD cases and 16 deaths. Disease-related costs decreased by USD 10.15 million, while vaccination costs increased by USD 19.71 million (BCR = 0.515). The intervention yielded 1,260.8 additional quality-adjusted life years (QALYs), with an ICER of USD 8,319.99/QALY, approximately 1.005 times the per capita GDP of Guangxi, indicating acceptable cost-effectiveness. Vaccine price was the most influential parameter; reducing the price to USD 14.94 per dose would achieve cost-benefit balance. Conclusions: Including the EV71 vaccine in the NIP would substantially reduce HFMD burden and is cost-effective. Price reductions could further improve economic outcomes and enable net societal benefits, supporting policy decisions in China and similar settings.