Cost-Effectiveness Of New Monoclonal Antibody And Maternal Immunization For The Prevention Of Respiratory Syncytial Virus (rsv) Disease In Infants: A Systematic Review

Abstract

AbstractIntroduction: Respiratory syncytial virus (RSV) remains a major cause of morbidity and mortality among infants and young children worldwide. Given the lack of specific therapeutic treatments for RSV that are suitable for universal use, the development of effective prevention strategies is of paramount importance. Previously, palivizumab was utilized for long-term prophylaxis of RSV infections; however, it was only recommended for specific populations due to its high cost and limited overall effectiveness. In 2023, the U.S. FDA approved RSVpreF maternal vaccine (Abrysvo™, Pfizer), and nirsevimab (Beyfortus™, Sanofi and AstraZeneca) for the prevention of RSV to newborns. Two newly developed interventions have demonstrated potential in reducing RSV burden in children aged 0-5 years and replaced existing interventions. However, their cost-effectiveness has not been systematically reviewed. This study aims to assess the cost-effectiveness of nirsevimab and RSVpreF in infants through a systematic review and provide some insights for policy making. Methods: Relevant studies were searched, screened and identified from PubMed, Scopus and Medline from 2020 to 2025. Studies were eligible if they met the multiple inclusion criteria based on Population, Intervention, Comparison, and Outcome (PICO) framework. The quality of included studies was assessed based on Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 statements. Risk of bias was assessed followed the advice from National Institute for Health and Clinical Excellence (NICE) in UK. For data analysis, extracted information from included studies and standardized all results to 2025 USD. Pooled incremental cost-effective ratios (ICERs )from high-income countries (HICs) and low- and middle-income countries (LMICs) and from different perspectives were estimated. Results: I identified 592 studies, of which 21 studies were included in the systematic review. Most studies indicated that nirsevimab and RSVpreF were cost-effective compared to no intervention and to the existing palivizumab (n=20). The pooled ICER for nirsevimab cost $20,326 ($541-$165,742) per quality-adjusted life-years (QALY) gained, and for RSVpreF was$58,589/QALY gained ($1,686-$427,836), compared with no interventions. In HICs, nirsevimab would cost $20,910/QALY ($3,562-$165,742), and the ICER for RSVpreF was$35,046/QALY ($13,028-$427,836). In LMICs, pooled ICER was $4,766/QALY ($541-$21,023) gained for nirsevimab and$7,756/QALY ($1,686-$25,564) gained. The sensitivity analysis highlighted that intervention cost and real-world effectiveness were critical factors influencing cost-effectiveness outcomes. Conclusion: Both nirsevimab and RSVpreF are cost-effective in preventing RSV in infants. From the results of the subgroup analysis, nirsevimab may be more cost-effective than RSVpreF. And due to contexts of different product prices and disease burden, RSVpreventions are more cost-effective in LMICs compared to HICs. These findings support the inclusion of RSV prophylaxis in immunization programs, with careful consideration of country-specific healthcare policies and economic conditions. Further studies are needed to assess potential biases from industry sponsorship and explore additional economic measures such as net monetary benefit (NMB) to strengthen cost-effectiveness evaluations