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. 2025 Aug;14(8):1883-1897.
doi: 10.1007/s40121-025-01193-4. Epub 2025 Jul 18.

Complementary Strategy of Maternal Immunization with RSVpreF Vaccine and Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus Among Italian Infants: A Cost-Effectiveness Assessment

Barbara Polistena  1   2 , Fabio Midulla  3 , Giovanni Sotgiu  4 , Daniela d'Angela  1   2 , Roberto Di Virgilio  5 , Federico Spandonaro  6   7
Affiliations

Complementary Strategy of Maternal Immunization with RSVpreF Vaccine and Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus Among Italian Infants: A Cost-Effectiveness Assessment

Barbara Polistena et al. Infect Dis Ther. 2025 Aug.

Abstract

Introduction: Respiratory Syncytial Virus (RSV) is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income countries where the healthcare systems not always have the resources to provide appropriate intensive care to all infants with severe RSV infection. On the basis of the results of a large programme of clinical trials, the European Medicine Agency has recently approved a Bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization, with a year-round administration between 24-36 weeks of gestation. The objective of the study is providing an estimation of the efficiency of complementary strategy RSVpreF and monoclonal antibodies for the prevention of RSV among Italian infants.

Methods: Using a model (with a cohort framework and a Markov-type process) specifically adapted to the Italian context, the study provided cost-effectiveness and cost-utility assessment of prevention strategies adding the maternal vaccination to the existing immunization opportunities with palivizumab or nirsevimab administered to high risk and unprotected infants.

Results: The complementary strategy RSVpreFV plus palivizumab demonstrates significative health benefits versus palivizumab alone: it would reduce annual hospitalizations by 4097 cases (-25.8%), Emergency Department (ED) admissions not followed by hospitalization by 534 (-18.8%), with 25 years of life recovered, and an increase of 90 Quality Adjusted Life Years (QALYs). The strategy results cost-saving: the complementary strategy saves € 6.0 mil and € 8.4 mil per year in the NHS and in the Societal perspective, respectively; the complementary strategies of maternal vaccination plus nirsevimab also prove to have significant benefits versus the monoclonal antibody alone, providing a decrease equal to 941 annual hospitalizations (-9.0%), 6 years of life recovered, and an increase of 20 QALYs. The strategy saves € 2.6 mil and € 3.1 mil per year in the NHS and in the Societal perspective, respectively.

Conclusions: RSV is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income; bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization proves to be effective in preventing RSV infections, avoiding severe disease. The modelling exercise shows that the complementary strategy of maternal vaccination with palivizumab or nirsevimab are both dominant (better health outcomes with lower costs) on monoclonal antibodies alone; the sensitivity analysis confirms that the complementary strategies in most of the simulation remain dominant or cost-effective adopting a low threshold for the willingness to pay; finally the complementary strategies are also sustainable, owing to a limited impact on the current national budget for vaccines.

Keywords: Complementary strategy for RSV prevention; Cost-consequences; Cost-effectiveness; Cost-utilities; Economic evaluation; Maternal immunization; Vaccines.

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Conflict of interest statement

Declarations. Conflict of Interest: Barbara Polistena received payments or fees for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Eli Lilly, Janssen Cilag, Nestlé HS, Novartis, Novo Nordisk, Pfizer, Servier, Takeda, Teva; in addition she received consulting fees from UCB. Fabio Midulla received payments or fees for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: AstraZeneca, MSD, Pfizer, Sanofi. Giovanni Sotgiu received payments or fees for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: AZ, INSMED, Pfizer, Quiagen. Daniela d’Angela received payments or fees for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Eli Lilly, Janssen Cilag, Nestlé HS, Novartis, Novo Nordisk, Pfizer, Servier, Takeda, Teva. Roberto Di Virgilio is a Pfizer employee. Federico Spandonaro received payments or fees for scientific advisory board lectures, presentations, speaker bureaus, manuscript writing or educational events from Celgene, Daiichy Sankyo, Eli Lilly, Janssen Cilag, Novartis, Novo Nordisk, Roche, Sanofi. Ethical Approval: The article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors; consequently no ethical approval was needed.

Figures

Fig. 1
Fig. 1
Model structure. LY life years, QALY quality adjusted life years, RSV respiratory syncytial virus
Fig. 2
Fig. 2
Probabilistic analysis: scatterplot (a) and acceptability curve (b)—NHS perspective—palivizumab scenario. NHS Italian National Health Service, QALY quality adjusted life years
See this image and copyright information in PMC

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