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. 2022 Aug 15;226(Suppl 2):S282-S292.
doi: 10.1093/infdis/jiac216.

Expected Impact of Universal Immunization With Nirsevimab Against RSV-Related Outcomes and Costs Among All US Infants in Their First RSV Season: A Static Model

Alexia Kieffer  1 , Matthieu Beuvelet  1 , Aditya Sardesai  2 , Robert Musci  2 , Sandra Milev  2 , Julie Roiz  3 , Jason K H Lee  4
Affiliations

Expected Impact of Universal Immunization With Nirsevimab Against RSV-Related Outcomes and Costs Among All US Infants in Their First RSV Season: A Static Model

Alexia Kieffer et al. J Infect Dis. .

Abstract

Background: Respiratory syncytial virus (RSV) is associated with substantial morbidity in the United States, especially among infants. Nirsevimab, an investigational long-acting monoclonal antibody, was evaluated as an immunoprophylactic strategy for infants in their first RSV season and for its potential impact on RSV-associated, medically attended lower respiratory tract illness (RSV-MALRTI) and associated costs.

Methods: A static decision-analytic model of the US birth cohort during its first RSV season was developed to estimate nirsevimab's impact on RSV-related health events and costs; model inputs included US-specific costs and epidemiological data. Modelled RSV-related outcomes included primary care and emergency room visits, hospitalizations including intensive care unit admission and mechanical ventilations, and RSV-related mortality.

Results: Under current standard of care, RSV caused 529 915 RSV-MALRTIs and 47 281 hospitalizations annually, representing $1.2 billion (2021 US dollars [USD]) in costs. Universal immunization of all infants with nirsevimab is expected to reduce 290 174 RSV-MALRTI, 24 986 hospitalizations, and expenditures of $612 million 2021 USD.

Conclusions: An all-infant immunization strategy with nirsevimab could substantially reduce the health and economic burden for US infants during their first RSV season. While this reduction is driven by term infants, all infants, including palivizumab-eligible and preterm infants, would benefit from this strategy.

Keywords: RSV; United States; burden; cost; economics; infants; lower respiratory tract illness; model; nirsevimab.

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Conflict of interest statement

Potential conflicts of interest. A. K., M. B., and J. L. are employees of Sanofi and may hold shares and/or stock options in the company. A. S., R. M., S. M., and J. R. are salaried employees of Evidera and are not allowed to accept remuneration from any clients for their services. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Risk and number of RSV-LRTI hospitalizations of US infants in their first respiratory syncytial virus season, by month of birth. Total values indicate number and percentage of RSV-LRTI hospitalizations occuring in infants born in season (October to February) and out of season (March to September). Vertical gray bars represent RSV season (October to March), error bars and values in square brackets reflect the uncertainty in RSV-LRTI hospitalizations associated with uncertainty in RSV rates. Abbreviations: mo, month; LRTI, lower respiratory tract illness; RSV, respiratory syncytial virus.
Figure 2.
Figure 2.
Respiratory syncytial virus-related health events of US infants in their first respiratory syncytial virus season under current standard of care or universal immunization with nirsevimab, by month of birth. Error bars reflect the uncertainty in RSV-MALRTIs associated with uncertainty in RSV rates. Abbreviations: ER, emergency room; ICU, intensive care unit; MV, mechanical ventilation; SoC, standard of care.
Figure 3.
Figure 3.
Deterministic sensitivity analysis tornado diagrams of prevented respiratory syncytial virus-related health events with nirsevimab immunization all US infants in their first RSV season, by event type: (A) inpatient hospitalizations (including ICU admissions and MV), (B) emergency room visits, and (C) primary care visits. aLB (for term infants only): hospitalizations, Hall et al [6]; ICU admissions, LB of 95% CI; MV, 20% reduction in risk of MV. bUB (for term infants only): hospitalization, Stockman et al [7]; ICU admissions, UB of 95% CI; MV, 20% increase in risk of MV. Abbreviations: CI, confidence interval; ER, emergency room; ICU, intensive care unit; LB, lower bound; MV, mechanical ventilation; RSV, respiratory syncytial virus; UB, upper bound.
Figure 4.
Figure 4.
Deterministic sensitivity analysis tornado diagrams of incremental costs (in 2021 USD) with nirsevimab immunization all US infants in their first RSV season, by population subgroup: (A) term infants, (B) preterm infants, and (C) palivizumab-eligible infants. Abbreviation: RSV, respiratory syncytial virus.
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