Health economic evaluation on prenatal screening strategies for Down's syndrome
Objective To explore effectiveness and health economic characteristics of prenatal screening strategies for Down's syndrome with Real-World Data and to provide scientific bases for optimizing prenatal screening strategies for DS.Methods The clinical data of the pregnant women with singleton pregnancies who received prenatal examination in 9 prenatal diagnosis centers in Shenzhen city from 2017 to 2019 were retrospectively analyzed.According to screening method,the pregnant women were divided into four groups:serological screening for DS in early pregnancy group,serological screening for DS in middle pregnancy group,non-invasive prenatal testing(NIPT)group and serological screening for DS in early pregnancy plus sequential NIPT group.The sensitivity,specificity,positive predictive value and accuracy of the four prenatal screening strategies for DS were compared.Cost-effectiveness and cost-benefit analyses were performed to compare the health economic characteristics of the four screening strategies from a social perspective.Results Among the study subjects in the four screening strategy groups,the average age of 154,533 pregnant women who underwent NIPT screening was 30.47±4.45 years,and the proportion of the pregnant women with average age ≥35 years was 19.81%,which was higher than those of the pregnant women who underwent serological screening in first trimester of pregnancy and serological screening in second trimester of pregnancy,and the difference was statistically significant(x2=9915.613,P<0.05).The sensitivity,specificity,positive predictive value and accuracy of NIPT screening for DS were 96.54%,99.96%,85.24%and 99.95%respectively,suggesting that the screening effectiveness of NIPT for DS was better than the other three strategies.The cost-effectiveness ratio of NIPT screening was 62.12,and the cost-benefit ratio was 1∶9.68,which were better than those of the other three strategies.Subgroup analysis results showed that the pregnant women either in the old maternal age group or in the young maternal age group,the cost-effectiveness ratio and the cost-benefit ratio of NIPT for screening DS were better than those of serological screening for DS and serological screening plus sequential NIPT(combined screening)strategies,especially for those elderly pregnant women.Conclusion NIPT screening improves the detection rate of DS and offers better social and economic benefits.