Valganciclovir Use Among Commercially and Medicaid-insured Infants With Congenital CMV Infection in the United States, 2009–2015

Abstract

Purpose To assess clinical characteristics and trends in valganciclovir use among infants diagnosed with congenital cytomegalovirus (CMV) disease in the United States. Methods We analyzed 2009–2015 medical claims from Truven Health MarketScan® Commercial Claims and Encounters and Medicaid databases. We identified infants with a live birth code in the first claim who were enrolled for at least 45 days. Among infants diagnosed with congenital CMV disease, identified by an ICD-9-CM or ICD-10-CM code of congenital CMV infection or CMV disease within 45 days of birth, we assessed codes for CMV-associated clinical condition within the same period, and hearing loss and valganciclovir claims within the first 180 days. Findings In the commercial and Medicaid databases, we identified 257 (2.5/10,000) and 445 (3.3/10,000) infants diagnosed with congenital CMV disease, respectively, among whom 135 (53%) and 282 (63%) had ≥1 CMV-associated condition, 30 (12%) and 32 (7%) had hearing loss, and 41 (16%) and 78 (18%) had valganciclovir claims. Among infants with congenital CMV disease who had valganciclovir claims, 37 (90%) among commercially-insured infants and 68 (87%) among Medicaid-insured infants had ≥1 CMV-associated condition and/or hearing loss. From 2009 to 2015, the proportion with valganciclovir claims increased from 0% to 29% among commercially-insured infants and from 4% to 37% among Medicaid-insured infants (p<0.0001). Implications During 2009–2015, there was a strong upward trend in valganciclovir claims among insured infants who were diagnosed with congenital CMV disease, the majority of whom had CMV-associated conditions and/or hearing loss.

Diagnosis and medical care for congenital cytomegalovirus infection

“…The claims-based diagnoses might not be accurate enough. [ 16 , 17 ] However, relatively high accuracy of diagnostic codes of common chronic conditions in the JMDC Claims Database [ 32 ] may support our case identification strategy. Third, some relevant information, including maternal data, test results, disease severity, brain imaging, and laterality of symptoms and/or sequelae, as well as the examinations and treatments not covered by the insurance, were not available through the claims data.…”

“…Symptoms not directly related to medical treatment, such as petechiae and hepatosplenomegaly, may not have been documented on the claims even though physicians recognized them. [ 17 ]…”

“…More than one-fourth of the patients received antiviral treatment, which was at a similar level of those reported in the United States. [ 17 ] The antivirals were prescribed predominantly for those with symptoms at birth, but we should note that even such patients may not have been followed up continuously with periodical objective hearing tests, especially after the first year of life. Although long-term monitoring and follow-up of cCMV patients have been recommended repeatedly by different authors, [ 2 , 18 , 28 , 31 ] further efforts would be needed to raise disease awareness among healthcare providers.…”

“…[ 7 , 10 ] These estimates, however, generally come from hospital-based prospective studies where the enrolled infants underwent extensive examinations and monitoring. [ 3 – 10 ] Much lower prevalence was observed in the studies based on surveillance, [ 11 – 13 ] questionnaire surveys, [ 14 , 15 ] or medical claims, [ 16 , 17 ] raising concerns about limited awareness and underdiagnosis of the disease in real-world clinical practices. [ 13 , 16 ]…”

Inconsistent Provider Testing Practices for Congenital Cytomegalovirus: Missed Diagnoses and Missed Opportunities

“…Formal reliability was not calculated although 10 random participant’s charts were verified by KW after coding was completed. All collected elements and variable definitions as well as further details can be found in the Supplemental Materials, Table S2 [ 3 , 12 , 13 , 14 , 15 , 16 , 17 , 18 ].…”