Leaning towards Cytomegalovirus serological screening in pregnancy to prevent congenital infection: a cost‐effectiveness perspective

Abstract

Objective To assess the cost-effectiveness of prenatal detection of congenital cytomegalovirus (cCMV) following maternal primary infection in the first trimester within standard pregnancy followup or involving population-based screening (serological testing at 7 and 12 weeks of gestation), with or without secondary prevention (valaciclovir) in maternal CMV primary infection.Design Cost-effectiveness study from the perspective of the French national health insurance system.Setting Cost-effectiveness based on previously published probability estimates and associated plausible ranges hypothetical population of 1,000,000 pregnant women.Population Hypothetical population of 1,000,000 pregnant women.Methods Cost-effectiveness of detecting fetal cCMV in terms of the total direct medical costs involved and associated expected outcomes.Main outcome measures Detection rates and clinical outcomes at birth. ResultsMoving to a population-based approach for targeting fetal CMV infections would generate high monetary and organizational costs while increasing detection rates from 15% to 94%. This resource allocation would help implementing horizontal equity according to which individuals with similar medical needs should be treated equally. Secondary prevention with valaciclovir had a significant effect on maternal-fetal CMV transmission and clinical outcomes in newborns, with a 58% decrease of severely infected newborns for a 3.5% additional total costs. Accounting for women decision-making (amniocentesis uptake and termination of pregnancy in severe cases) did not impact the cost-effectiveness results.Conclusions These findings could fuel thinking on the opportunity of developing clinical guidelines to rule identification of cCMV infection and administration of in-utero treatment. These findings could fuel the development of clinical guidelines on the identification of congenital CMV infection and the administration of treatment in utero.

Primary, Secondary, and Tertiary Prevention of Congenital Cytomegalovirus Infection

“…A French study assessed the cost-effectiveness of prenatal detection of congenital cytomegalovirus following maternal primary infection during the first trimester within standard pregnancy follow-up or involving population-based screening (serological testing at 7 and 12 weeks of gestation). CMV serological screening followed by valaciclovir prevention might prevent 58% to 71% of severe congenital CMV cases for a cost of EUR 38 per pregnancy [112]. In this study, the cost of postnatal sequelae and care for these children was not considered.…”

“…Secondary prevention aims to avoid or reduce the risk of maternal-fetal transmission in case of proven CMV seroconversion in the mother [110]. The literature on secondary prevention of cCMV focuses on two complementary topics: maternal serological screening [111,112] and prophylactic therapies, including administration of hyperimmune globulin [24,113,114] or antiviral therapy [115]. Currently, practices regarding the application of these methods are site-specific as the effectiveness of these methods is still considered controversial [116].…”

“…Even if the sensitivity and specificity of specific CMV IgM are good (>90%), they are far less reliable for the diagnosis of primary infection [118] (positive predictive value of 15-40%, depending on if it is universal or target screening) [119]. Indeed, CMV-IgM can possibly indicate an acute or a recent infection, but most often, positivity is due to other causes, such as long-term persisting IgM, cross-reaction, secondary CMV infection, or nonspecific stimulation of the immune system [112]. This lack of specificity in predicting recent primary infection can lead to misinterpretation of results, causing an assumption of a primary infection.…”

Cost‐effectiveness of screening and valacyclovir‐based treatment strategies for first‐trimester cytomegalovirus primary infection in pregnant women in France

“…We assessed the model's external validity by comparing external data from the literature 19,29,34 with the results for Strategy S1 (no systematic screening) in our model. The model results were close to the external data (Table S3).…”

Cross-sectional study to assess awareness of cytomegalovirus infection among pregnant women in Germany

“…Several studies have shown that most pregnant women know little about CMV infection [ 23 ]. Although the role of CMV screening during pregnancy has been discussed over the last decade [ 24 , 25 ], CMV is the least known in pregnant women compared to other congenital infections or diseases [ 26 , 27 ].…”