Cost-Effectiveness Analysis of the mRNA-1345 RSV Vaccine for Older Adults in Italy

Introduction Respiratory syncytial virus (RSV) is an important cause of respiratory disease in older adults and adults with chronic medical conditions, contributing substantially to the healthcare burden in Italy. The availability of effective RSV vaccines provides an opportunity to reduce RSV-related morbidity, mortality, and healthcare costs in populations at high risk of severe disease. This study evaluates the potential public health impact and cost-effectiveness of vaccination using mRNA-1345 administered as a single dose compared with no vaccination in Italian high-risk adults aged 60-74 years and all adults aged [≥]75 years. Methods A static decision-analytic model was developed to project clinical and economic outcomes over a 5-year time horizon. Economic outcomes were evaluated from the Italian National Health Service (Servizio Sanitario Nazionale, SSN) perspective. Model inputs were informed by the most recent Italian epidemiological, clinical, and economic evidence, supplemented by published international data when necessary. Deterministic, probabilistic, and scenario analyses were conducted to assess the impact of uncertainty in model inputs and assumptions on the study results. Results Vaccination with mRNA-1345 in high-risk adults aged 60-74 years and all adults aged [≥]75 years was projected to avert over 19,800 hospitalizations, 4,000 emergency department visits, 381,000 outpatient visits, 6,000 RSV-attributable deaths, and 212,000 antibiotic prescriptions compared with no vaccination over a 5-year period. The total incremental cost of {euro}1,143 million and the additional 47,477 QALYs gained resulted in an ICER of {euro}24,078, which was below the commonly referenced willingness to-pay range of {euro}33,000-40,000 per QALY gained. Sensitivity analyses confirmed robustness of the analysis results. Conclusions Vaccination with mRNA-1345 is a cost-effective strategy for the prevention of RSV in high-risk adults aged 60-74 years and all adults [≥]75 years in Italy and has the potential to provide substantial public health benefits.