Search

Background: Respiratory syncytial virus (RSV) causes a considerable disease burden in young children globally, but reliable estimates of RSV-related costs and health-related quality-of-life (HRQoL) are scarce. This study aimed to evaluate the RSV-associated costs and HRQoL effects in infants and their caregivers in four European countries., Methods: Healthy term-born infants were recruited at birth and actively followed up in four European countries. Symptomatic infants were systematically tested for RSV. Caregivers recorded the daily HRQoL of their child and themselves, measured by a modified EQ-5D with Visual Analogue Scale, for 14 consecutive days or until symptoms resolved. At the end of each RSV episode, caregivers reported healthcare resource use and work absenteeism. Direct medical costs per RSV episode were estimated from a healthcare payer's perspective and indirect costs were estimated from a societal perspective. Means and 95% confidence intervals (CI) of direct medical costs, total costs (direct costs + productivity loss) and quality-adjusted life-day (QALD) loss per RSV episode were estimated per RSV episode, as well as per subgroup (medical attendance, country)., Results: Our cohort of 1041 infants experienced 265 RSV episodes with a mean symptom duration of 12.5 days. The mean (95% CI) cost per RSV episode was €399.5 (242.3, 584.2) and €494.3 (317.7, 696.1) from the healthcare payer's and societal perspective, respectively. The mean QALD loss per RSV episode of 1.9 (1.7, 2.1) was independent of medical attendance (in contrast to costs, which also differed by country). Caregiver and infant HRQoL evolved similarly., Conclusion: This study fills essential gaps for future economic evaluations by prospectively estimating direct and indirect costs and HRQoL effects on healthy term infants and caregivers separately, for both medically attended (MA) and non-MA laboratory-confirmed RSV episodes. We generally observed greater HRQoL losses than in previous studies which used non-community and/or non-prospective designs., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: 'PB reported consulting fees from Pfizer, GSK on 2 occasions for discussions on economic evaluation, for a total of <€3000 combined, paid 100% directly to the University of Antwerp. NH reported grants from Janssen Vaccines & Prevention BV (R-11873) for collection of social contact data relevant for the spread of respiratory pathogens including SARS-CoV-2, RSV, influenza. NH reports consulting fees from Janssen Global Services for participation in advisory board related to RSV disease transmission modelling; payments made to Hasselt University. LB has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. UMCU has received major funding (>€100,000 per industrial partner) for investigator initiated studies from AbbVie, MedImmune, Janssen, the Bill and Melinda Gates Foundation, Nutricia (Danone) and MeMed Diagnostics. UMCU has received major cash or in kind funding as part of the public private partnership IMI-funded RESCEU project from GSK, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi. UMCU has received major funding by Julius Clinical for participating in the INFORM study sponsored by MedImmune. UMCU has received minor funding for participation in trials by Regeneron and Janssen from 2015-2017 (total annual estimate less than €20,000). UMCU received minor funding for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, Novavax, Pfizer, Janssen (total annual estimate less than €20,000). Dr. Bont is the founding chairman of the ReSViNET Foundation. SC reported IMI – RESCEU grant funding (as detailed in manuscript), with fees paid to the University of Edinburgh. FM-T has received honoraria from GSK group of companies, Pfizer Inc, Sanofi Pasteur, MSD, Seqirus, Biofabri and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. FM-T has also acted as principal investigator in randomized controlled trials of the above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. TH has received honoraria for lectures and/or participation in advisory boards or data monitoring committees from Janssen, Sanofi Pasteur, Enanta and MSD. MDS acted until September 2022 on behalf of the University of Oxford as an Investigator on research studies funded or supported by the vaccine manufacturers GlaxoSmithKline, Janssen, AstraZeneca, Novavax, MCM vaccines and Pfizer. He received no direct personal benefit for this work. From September 2022 he has been an employee at Moderna Biotech UK and holds stock options in this company. AJP is a member of AMS and Senior Investigator of NIHR. KK has received fees for interview for expert opinion considering the burden of RSV in older adults with IQVIA (part of Janssen) as well as interview for expert opinion considering the burden of RSV in older adults with Deallus. AD has participated as sub-investigator in clinical trials and observational studies for Novavax, MedImmune, Janssen GSK, Pfizer, Merk, Sharp Donme, ReViral, Enanta Pharmaceuticals. All payments were made to the institution and no direct payment was received. MJP is a member of JCVI and reports stock or stock options for HealthEcore (25% of shares) and PAG BV (100% of shares). All other authors report no potential conflicts of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)