Cost-Effectiveness Analysis of the mRNA-1345 RSV Vaccine for Older Adults in Italy
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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 €1,143 million and the additional 47,477 QALYs gained resulted in an ICER of €24,078, which was below the commonly referenced willingness to-pay range of €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.
Key Summary Points
Why carry out this study?
The clinical and economic burden of respiratory syncytial virus (RSV) in high-risk and older adults is significant. RSV vaccines have received regulatory authorization in Europe, and national recommendations or immunization programs for older adults have been introduced in several countries including Germany, France, Spain and the United Kingdom. In Italy, RSV vaccination for older adults has not yet been implemented as a uniform national program, however such a program has been endorsed by several scientific societies.
The study objective was to estimate 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, in the 5-year period following vaccination.
What was learned from the study?
Vaccination of high-risk adults aged 60-74 years and all adults aged ≥75 years with mRNA- 1345 was projected to prevent more than 19,800 hospitalizations, 4,000 ED visits, 381,000 outpatient visits, 6,000 RSV-attributable deaths, and 212,000 antibiotic prescriptions (up to 21% reduction across outcomes), in comparison to no vaccination, over a 5-year period.
This analysis suggests the mRNA-1345 vaccine is a cost-effective strategy for the prevention of RSV in high-risk adults in Italy and has the potential for substantial public health benefit.
Our findings provide evidence to inform national immunization policy and reimbursement decisions, and support the implementation of an RSV vaccination program for high-risk adults aged 60-74 years and all adults aged ≥75 years in Italy.
Plain Language Summary
Respiratory syncytial virus (RSV) is a common virus that causes lung infections. It can be especially dangerous for older adults and people with health conditions like asthma, heart disease, or diabetes. Each year, RSV causes many hospitalizations and deaths in Italy. A new vaccine called mRNA-1345 was recently approved to protect individuals aged 18 years and older against severe RSV disease. This study looked at whether vaccinating the most vulnerable adults, particularly people aged 60-74 years with chronic health conditions and everyone aged 75 years and older, would help reduce the burden of RSV and provide good value for money for the healthcare system. Researchers used a mathematical model to compare what might happen over 5 years with and without vaccination. They found that using a single-dose vaccination strategy could prevent over 19,800 hospitalizations and more than 6,000 deaths over the following 5 years. Although vaccination requires investments, the health benefits are estimated to be large enough for mRNA-1345 to provide good value for money for the Italian healthcare system.
