Diaz-Decaro John, Demmler-Harrison Gail J, Marden Jessica R, Anderson Annika, Basnet Sandeep, Gaburo Katherine, Kirson Noam, Desai Urvi, Buck Philip O
Moderna, Inc, Cambridge, Massachusetts.
Baylor College of Medicine, Pediatric Infectious Disease, Texas Children's Hospital, Houston, Texas.
Clin Ther. 2025 Jun;47(6):426-435. doi: 10.1016/j.clinthera.2025.03.006. Epub 2025 Apr 9.
Congenital cytomegalovirus (cCMV) is the leading infectious cause of congenital birth defects. Although approximately 20% to 25% of infants born with cCMV develop long-term health complications such as sensorineural hearing loss, developmental issues, and microcephaly, studies on the disease burden of cCMV are limited. In this study, we assessed the epidemiology, economic burden, and disease burden of clinically diagnosed cCMV in the United States using insurance claims data.
This retrospective study utilized Merative MarketScan Commercial Claims and Encounters and Multi-State Medicaid data from 2010 to 2019. Annual prevalence of clinically diagnosed cCMV at birth was estimated separately for each payer population. To assess economic burden, infants whose first cCMV diagnosis (index date) was within 1 month of birth were included in the cCMV cohort and matched to infants without cCMV infection for whom an index date was selected at random from all medical claims within 1 month of birth. Cohorts were matched 1:1 on demographics, insurance type, birth, and index years. All infants were required to have ≥2 years of continuous enrollment with prescription drug coverage after the index date (study period). Health care resource use and costs in 2021 USD ($) were summarized separately for the first and second years of the study period. Costs for birth admissions were also described.
The prevalence of clinically diagnosed cCMV at birth peaked in 2018 at 18.43 and 34.37 per 100,000 in the commercial and Medicaid populations, respectively. One hundred eighteen commercially insured (mean age at index date, 0.3 months; 46.6% female) and 351 Medicaid-insured matched pairs (mean age at index date, 0.2 months; 43.6% female) were included in the economic burden analyses. Mean (median) birth admission costs for commercially and Medicaid-insured infants with clinically diagnosed cCMV were $195,630 ($22,896; vs $24,195 [$3105]) and $57,182 ($9807; vs $5732 [$1566]), respectively. Additionally, excess costs due to cCMV in years 1 and 2 were $9427 ($5089) and $15,901 ($1573) for commercially insured, and $11,104 ($1446) and $12,205 ($721) for Medicaid-insured, respectively. Among potential cCMV sequelae, infants in the cCMV cohort experienced higher rates of hearing loss and developmental/motor delays during the first 2 years.
Diagnosed prevalence of cCMV at birth increased over time from 2010 to 2018. Infants with clinically diagnosed cCMV have costlier birth admissions and substantial disease burden in the first 2 years of life. These results emphasize the need for primary prevention methods, such as vaccination, to decrease the burden of cCMV.
先天性巨细胞病毒(cCMV)是先天性出生缺陷的主要感染原因。尽管约20%至25%出生时感染cCMV的婴儿会出现长期健康并发症,如感音神经性听力损失、发育问题和小头畸形,但关于cCMV疾病负担的研究有限。在本研究中,我们使用保险理赔数据评估了美国临床诊断cCMV的流行病学、经济负担和疾病负担。
这项回顾性研究利用了2010年至2019年的Merative MarketScan商业理赔与病历以及多州医疗补助数据。分别针对每个付款人群估计出生时临床诊断cCMV的年度患病率。为评估经济负担,将首次cCMV诊断(索引日期)在出生后1个月内的婴儿纳入cCMV队列,并与未感染cCMV的婴儿进行匹配,后者的索引日期是从出生后1个月内的所有医疗理赔中随机选择的。队列在人口统计学、保险类型、出生年份和索引年份方面按1:1进行匹配。所有婴儿在索引日期(研究期)后需有至少2年的连续参保且包含处方药保险。分别汇总研究期第一年和第二年以2021年美元($)计的医疗保健资源使用和成本。还描述了出生住院费用。
出生时临床诊断cCMV的患病率在2018年达到峰值,商业人群和医疗补助人群中分别为每10万人18.43例和34.37例。经济负担分析纳入了118对商业保险匹配对(索引日期时的平均年龄为0.3个月;46.6%为女性)和351对医疗补助保险匹配对(索引日期时的平均年龄为0.2个月;43.6%为女性)。临床诊断cCMV的商业保险和医疗补助保险婴儿的平均(中位数)出生住院费用分别为195,630美元(22,896美元;对比24,195美元[$3105])和57,182美元(9807美元;对比5732美元[$1566])。此外第一年和第二年因cCMV产生的额外费用,商业保险婴儿分别为9427美元(5089美元)和15,901美元(1573美元),医疗补助保险婴儿分别为11,104美元(1446美元)和12,205美元(721美元)。在潜在的cCMV后遗症中,cCMV队列中的婴儿在头两年出现听力损失和发育/运动迟缓的比率更高。
2010年至2018年期间,出生时cCMV的诊断患病率随时间增加。临床诊断cCMV的婴儿出生住院费用更高,且在生命的头两年有相当大的疾病负担。这些结果强调了需要诸如疫苗接种等一级预防方法来减轻cCMV的负担。