Abstract
BackgroundChina accounted for 87% (9.8 million/11.3 million) of all hand, foot, and mouth disease (HFMD) cases reported to WHO during 2010–2014. Enterovirus 71 (EV71) is responsible for most of the severe HFMD cases. Three EV71 vaccines recently demonstrated good efficacy in children aged 6–71 mo. Here we assessed the cost-effectiveness of routine pediatric EV71 vaccination in China.Methods and FindingsWe characterized the economic and health burden of EV71-associated HFMD (EV71-HFMD) in China using (i) the national surveillance database, (ii) virological surveillance records from all provinces, and (iii) a caregiver survey on the household costs and health utility loss for 1,787 laboratory-confirmed pediatric cases. Using a static model parameterized with these data, we estimated the effective vaccine cost (EVC, defined as cost/efficacy or simply the cost of a 100% efficacious vaccine) below which routine pediatric vaccination would be considered cost-effective. We performed the base-case analysis from the societal perspective with a willingness-to-pay threshold of one times the gross domestic product per capita (GDPpc) and an annual discount rate of 3%. We performed uncertainty analysis by (i) accounting for the uncertainty in the risk of EV71-HFMD due to missing laboratory data in the national database, (ii) excluding productivity loss of parents and caregivers, (iii) increasing the willingness-to-pay threshold to three times GDPpc, (iv) increasing the discount rate to 6%, and (v) accounting for the proportion of EV71-HFMD cases not registered by national surveillance. In each of these scenarios, we performed probabilistic sensitivity analysis to account for parametric uncertainty in our estimates of the risk of EV71-HFMD and the expected costs and health utility loss due to EV71-HFMD. Routine pediatric EV71 vaccination would be cost-saving if the all-inclusive EVC is below US$10.6 (95% CI US$9.7–US$11.5) and would remain cost-effective if EVC is below US$17.9 (95% CI US$16.9–US$18.8) in the base case, but these ceilings could be up to 66% higher if all the test-negative cases with missing laboratory data are EV71-HFMD. The EVC ceiling is (i) 10%–14% lower if productivity loss of parents/caregivers is excluded, (ii) 58%–84% higher if the willingness-to-pay threshold is increased to three times GDPpc, (iii) 14%–19% lower if the discount rate is increased to 6%, and (iv) 36% (95% CI 23%–50%) higher if the proportion of EV71-HFMD registered by national surveillance is the same as that observed in the three EV71 vaccine phase III trials. The validity of our results relies on the following assumptions: (i) self-reported hospital charges are a good proxy for the opportunity cost of care, (ii) the cost and health utility loss estimates based on laboratory-confirmed EV71-HFMD cases are representative of all EV71-HFMD cases, and (iii) the long-term average risk of EV71-HFMD in the future is similar to that registered by national surveillance during 2010–2013.ConclusionsCompared to no vaccination, routine pediatric EV71 vaccination would be very cost-effective in China if the cost of immunization (including all logistical, procurement, and administration costs needed to confer 5 y of vaccine protection) is below US$12.0–US$18.3, depending on the choice of vaccine among the three candidates. Given that the annual number of births in China has been around 16 million in recent years, the annual costs for routine pediatric EV71 vaccination at this cost range should not exceed US$192–US$293 million. Our results can be used to determine the optimal vaccine when the prices of the three vaccines are known.
Highlights
Since the 1990s, large epidemics of hand, foot, and mouth disease (HFMD) have occurred across the Western Pacific region [1,2,3,4,5,6]
In China, which accounted for 87% (9.8 million/11.3 million) of all HFMD cases reported to World Health Organization (WHO) during 2010–2014 [7], HFMD epidemics have been occurring annually since 2007
We considered all possible combinations of the following decision-making uncertainty associated with the choices of cost-effectiveness analysis (CEA) parameters: (i) inclusion or exclusion of productivity loss of parents or caregivers due to caring for their sick children, (ii) discounting costs and health utility loss at 3% or 6%, and (iii) using one or three times gross domestic product per capita (GDPpc) as the willingness-to-pay threshold
Summary
Since the 1990s, large epidemics of hand, foot, and mouth disease (HFMD) have occurred across the Western Pacific region [1,2,3,4,5,6]. In China, which accounted for 87% (9.8 million/11.3 million) of all HFMD cases reported to WHO during 2010–2014 [7], HFMD epidemics have been occurring annually since 2007. In 2012, HFMD ranked first among all notifiable diseases in China by both case count and deaths for children under 5 y [8]. China accounted for 87% (9.8 million/11.3 million) of all hand, foot, and mouth disease (HFMD) cases reported to WHO during 2010–2014. Since 2007, outbreaks of hand, foot, and mouth disease (HFMD)—a contagious infection that mainly affects young children—have been occurring annually in China. Some individuals develop potentially fatal complications such as encephalitis (infection and inflammation of the brain)
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