| Objectives:(1) To understand the epidemiological characteristics of disease caused by enterovirus type 71, thereby providing parameters for the construction and verification of the model. (2) To understand the disease burden of caused by enterovirus type 71, preliminary estimate the direct and indirect economic loss and the impact on the quality of life of illness children, provide evidence for developing the strategies to prevent the infectious diseases. (3) From the perspective of the health sector and the community, and based on the cost-effectiveness, cost-benefit and cost-utility to evaluate the cost and benefit of EV71 vaccine, provide the economics support for the vaccine go on sale.Methods:In this study, the information of epidemiological characteristics obtained from the follow-up data of the EV71 vaccine Phase Ⅲ clinical trials. Select all 380 cases of EV71-associated disease from Ganyu and Sheyang county which reported between 2011 and 2013, designed a questionnaire to investigate the disease burden of each case, to understand the direct economic burden, indirect economic burden, intangible economic burden and the lost of disability-adjusted life year (DALY) of EV7-associated disease.The result of Phase Ⅲ clinical trial show that the vaccine efficacy to protect against EV71-associated disease was 95.0%(95%CI 87.0%-97.8%). Assuming the vaccine effectiveness will not change in five years, establish the decisions-Markov model for the EV71 immune intervention and the progression of disease caused by EV71, evaluate the health economics of EV71 vaccine for children from 6 months to 5 years of age. Based on the vaccination cost of the vaccine and disease burden, obtained the effect, benefits utility of vaccination and no vaccination via the model simulation, according to the input-output principles of health economics, from three aspects: cost-effect, cost-benefit and cost-utility to evaluate the vaccine immune intervention.Results:There were 566 people had some level of lost to follow-up among 10158 monitoring objects from March 2012 to February 2013, the completion rate of follow-up was 94.43%.150 cases of disease caused by EV71 was reported by the Monitoring systems, the incidence rate of EV7-associated disease was 15.17/thousand pepole one year, male incidence rate was 16.23/ thousand pepole one year while female was 13.89/thousand pepole one year. The case was given priority to with hand, foot and mouth disease (HFMD) (82.00%), majority of the patients were between 12 and 23 months of age, which accounted for 58.67% of the total patients. The peak incidence density of disease caused by EV71 occurred from April to June. Nine cases showed severe symptoms or signs that accounted for 6.00%of all the cases. All severe cases were identified as HFMD.The survey found that the mean direct, indirect, intangible economic burden was 3955.70 RMB,444.74 RMB,3270.29 RMB per person, respectively. The difference of the mean direct, indirect, intangible and total economic burden per person between different diseases was statistical significance. The severe HFMD was the highest and the respiratory system disease was lowest. The disability adjusted life year (DALY) of 317 Children with disability was 0.62, and the burden of strength per person was 1.96 DALYs/thousand. The burden of strength between the cases of different disease was significantly different, of which the severe HFMD was the highest and the herpangina was lowest.If the vaccine pricing for 300 RMB (2-dose), the results of decision-Markov cohort model simulation (sample 1000000) Show that EV71 vaccine would prevent 69,567 cases of EV71 infection,10,910 cases of hospitalized cases,30,413 cases of outpatient cases and 1655 cases deaths within five year after the full vaccination precedure, the cost-effectiveness ratio (CER) of vaccination is 4647.89 and the cost-benefit ratio (CBR) is 1:7.69. The cost-utility ratio (CUR) of vaccination was 154.62 RMB/DALY and the cost-utility ratio (CUR) of non-vaccination was 669.08 RMB/DALY, the incremental cost-effectiveness ratio (ICER) is 57079.25 RMB/DALY, inoculated with EV71 vaccine is the dominant strategy. Select the four variables of vaccine price, vaccine efficacy, discount rate, natural mortality rate of children younger five years to conduct Monte Carlo one-way sensitivity analysis and probabilistic sensitivity analysis, the results have shown that the vaccination is absolutely dominant strategy.Conclusion:(1) Majority of the disease that caused by EV71 appeared as HFMD. Most of them were younger childrenand with seasonal variation. (2) EV7-associated disease have brought a heavy financial burden to society and the family, meanwhile seriously affected the quality of life of illness children, the economic and health burden of severe HFMD cases was significantly higher than the other disease; (3) There were a good cost-effectiveness, cost-benefit ratio, cost-utility ratio and incremental cost-effectiveness ratio for EV71 vaccine intervention, compared with no vaccination, vaccination has an absolute advantage. |
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