Economic and clinical burden associated with respiratory syncytial virus and impact of universal immunization with nirsevimab in Italy

Authors

  • Andrea Marcellusi Centre for Economics and International Studies-Economic Evaluation and Health Technology Assessment, Faculty of Economics, University of Rome “Tor Vergata”, Rome - Italy
  • Chiara Bini Centre for Economics and International Studies-Economic Evaluation and Health Technology Assessment, Faculty of Economics, University of Rome “Tor Vergata”, Rome - Italy
  • Barbara Muzii Sanofi, Rome - Italy https://orcid.org/0009-0006-1656-1314
  • Samira Soudani Sanofi, Lyon - France https://orcid.org/0009-0006-4523-6588
  • Alexia Kieffer Sanofi, Lyon - France
  • Matthieu Beuvelet Sanofi, Lyon - France
  • Elena Bozzola IRCCS Bambino Gesù Children Hospital, Rome - Italy https://orcid.org/0000-0001-5947-2414
  • Fabio Midulla Department of Maternal Science, Paediatric Emergency Service, Sapienza University of Rome, Rome - Italy
  • Eugenio Baraldi Department of Women’s and Children’s Health, University of Padova, Institute of Pediatric Research “Città della Speranza”, Padova - Italy
  • Paolo Bonanni Department of Health Sciences, University of Florence, Florence - Italy https://orcid.org/0000-0003-2875-3744
  • Sara Boccalini Department of Health Sciences, University of Florence, Florence - Italy https://orcid.org/0000-0002-9695-7549
  • Luigi Orfeo Neonatal Intensive Care Unit, “Isola Tiberina Hospital - Gemelli Isola”, Rome - Italy

DOI:

https://doi.org/10.33393/grhta.2025.3182

Keywords:

Cost of Illness, Prevention strategy, Respiratory syncytial virus, Universal immunization

Abstract

Objectives: To describe the seasonal respiratory syncytial virus (RSV) burden in Italy considering the current prophylaxis strategy with palivizumab recommended only for high-risk infants (representing only 4.4% of an estimated birth cohort) and to evaluate the potential benefits of a new prophylaxis strategy targeting all infants with nirsevimab.

Methods: A static decision analytic model previously used in the US was adapted to evaluate the RSV-related health and cost outcomes associated with nirsevimab versus standard of care (SoC) for the prevention of RSV medically attended lower respiratory tract infections (RSV-MA-LRTIs). Monthly probabilities of RSV infections, health events, mortality, and complications associated with RSV infections were obtained from the literature. Costs associated with each event were obtained using the available literature and through real-world data analysis of National Hospital Discharge Records.

Results: For one RSV season, in the current SoC, the model estimated 216,100 RSV-MA-LRTIs, 15,121 associated complications, and 16 RSV-deaths–corresponding to an economic burden of approximately €50.5 million related to RSV-MA-LRTIs management, €10.9 million associated with potential complications due to RSV and €3 million in lost productivity due to RSV-deaths. Nirsevimab is expected to prevent 100,208 RSV-MA-LRTIs, 6,969 complications, and 6 deaths due to RSV infections, corresponding to an economic saving of about €23.3, €5, and €1.2 million, respectively.

Conclusion: Nirsevimab is a new prophylaxis strategy that helps to protect all infants against RSV disease and could substantially reduce the clinical and economic burden of RSV in Italy in infants experiencing their first RSV season.

Downloads

Download data is not yet available.

References

Cutrera R, Wolfler A, Picone S, et al. Impact of the 2014 American Academy of Pediatrics recommendation and of the resulting limited financial coverage by the Italian Medicines Agency for palivizumab prophylaxis on the RSV-associated hospitalizations in preterm infants during the 2016-2017 epidemic season: a systematic review of seven Italian reports. Ital J Pediatr. 2019;45(1):139. https://doi.org/10.1186/s13052-019-0736-5 PMID:31706338 DOI: https://doi.org/10.1186/s13052-019-0736-5

Janet S, Broad J, Snape MD. Respiratory syncytial virus seasonality and its implications on prevention strategies. Hum Vaccin Immunother. 2018;14(1):234-244. https://doi.org/10.1080/21645515.2017.1403707 PMID:29194014 DOI: https://doi.org/10.1080/21645515.2017.1403707

Mazur NI, Martinón-Torres F, Baraldi E, et al. Respiratory Syncytial Virus Network (ReSViNET). Lower respiratory tract infection caused by respiratory syncytial virus: current management and new therapeutics. Lancet Respir Med. 2015;3(11):888-900. https://doi.org/10.1016/S2213-2600(15)00255-6 PMID:26411809 DOI: https://doi.org/10.1016/S2213-2600(15)00255-6

Bont L, Checchia PA, Fauroux B, et al. Defining the epidemiology and burden of severe respiratory syncytial virus infection among infants and children in Western countries. Infect Dis Ther. 2016;5(3):271-298. https://doi.org/10.1007/s40121-016-0123-0 PMID:27480325 DOI: https://doi.org/10.1007/s40121-016-0123-0

Azzari C, Baraldi E, Bonanni P, et al. Epidemiology and prevention of respiratory syncytial virus infections in children in Italy. Ital J Pediatr. 2021;47(1):198. https://doi.org/10.1186/s13052-021-01148-8 PMID:34600591 DOI: https://doi.org/10.1186/s13052-021-01148-8

Manti S, Staiano A, Orfeo L, et al. UPDATE - 2022 Italian guidelines on the management of bronchiolitis in infants. Ital J Pediatr. 2023;49(1):19. https://doi.org/10.1186/s13052-022-01392-6 PMID:36765418 DOI: https://doi.org/10.1186/s13052-022-01392-6

Barbati F, Moriondo M, Pisano L, et al. Epidemiology of respiratory syncytial virus-related hospitalization over a 5-year period in Italy: evaluation of seasonality and age distribution before vaccine introduction. Vaccines (Basel). 2020;8(1):15. https://doi.org/10.3390/vaccines8010015 PMID:31947976 DOI: https://doi.org/10.3390/vaccines8010015

Barbieri E, Cavagnis S, Scamarcia A, et al. Assessing the burden of bronchiolitis and lower respiratory tract infections in children ≤24 months of age in Italy, 2012-2019. Front Pediatr. 2023;11:1143735. https://doi.org/10.3389/fped.2023.1143735 PMID:37215598 DOI: https://doi.org/10.3389/fped.2023.1143735

Bechini A, Salvati C, Bonito B, et al. Costs and healthcare utilization due to respiratory syncytial virus disease in paediatric patients in Italy: a systematic review. Public Health. 2024;227:103-111. https://doi.org/10.1016/j.puhe.2023.11.039 PMID:38154422 DOI: https://doi.org/10.1016/j.puhe.2023.11.039

Bozzola E, Ciarlitto C, Guolo S, et al. Respiratory syncytial virus bronchiolitis in infancy: the acute hospitalization cost. Front Pediatr. 2021;8:594898. https://doi.org/10.3389/fped.2020.594898 PMID:33537260 DOI: https://doi.org/10.3389/fped.2020.594898

Kobelt G, Woronoff AS, Richard B, et al. Disease status, costs and quality of life of patients with rheumatoid arthritis in France: the ECO-PR Study. Joint Bone Spine. 2008;75(4):408-415. https://doi.org/10.1016/j.jbspin.2007.07.015 PMID:18455949 DOI: https://doi.org/10.1016/j.jbspin.2007.07.015

Kieffer A, Beuvelet M, Sardesai A, et al. 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. J Infect Dis. 2022;226(suppl 2):S282-S292. https://doi.org/10.1093/infdis/jiac216 PMID:35968866 DOI: https://doi.org/10.1093/infdis/jiac216

ISTAT. Popolazione residente al 1° gennaio 2023. Online http://dati.istat.it/Index.aspx?DataSetCode=DCIS_POPRES1 (Accessed June 2024)

Associazione Nazionale Malati Reumatici (ANMAR), Società Italiana di Reumatologia (SIR), and Fondazione Censis. Un percorso ad ostacoli. Primo rapporto sociale sull’artrite reumatoide 2008. Online http://www.reumatologia.it/obj/file/RapportoSociale.pdf. (Accessed June 2024)

Ministero della Salute. Certificato di assistenza al parto (CeDAP). Analisi dell’evento nascita - Anno 2021. Online https://www.salute.gov.it/imgs/C_17_pubblicazioni_3264_allegato.pdf. (Accessed June 2024)

ORPHANET, Displasia broncopolmonare.

https://www.orpha.net/it/disease/detail/70589#:~:text=La%20displasia%20broncopolmonare%20%C3%A8%20una,polmoni%20nei%20neonati%20pi%C3%B9%20grandi

SIP. Cardiopatie congenite, 5 cose da sapere. Online https://sip.it/2020/02/13/cardiopatie-congenite-5-cose-da-sapere/#:~:text=Le%20cardiopatie%20congenite%20(CC)%20sono,importanti%20di%20mortalit%C3%A0%20in%20epoca. (Accessed June 2024)

Simões EAF, Madhi SA, Muller WJ, et al. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomized controlled trials. Lancet Child Adolesc Health. 2023;7(3):180-189. https://doi.org/10.1016/S2352-4642(22)00321-2 PMID:36634694 DOI: https://doi.org/10.1016/S2352-4642(22)00321-2

Domachowske J, Madhi SA, Simões EAF, et al; MEDLEY Study Group. Safety of nirsevimab for rsv in infants with heart or lung disease or prematurity. N Engl J Med. 2022;386(9):892-894. https://doi.org/10.1056/NEJMc2112186 PMID:35235733 DOI: https://doi.org/10.1056/NEJMc2112186

Andabaka T, Nickerson JW, Rojas-Reyes MX, et al. Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database Syst Rev. 2013;(4):CD006602. PMID:23633336 DOI: https://doi.org/10.1002/14651858.CD006602.pub4

Feltes TF, Cabalka AK, Meissner HC, et al. Cardiac Synagis Study Group. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003;143(4):532-540. https://doi.org/10.1067/S0022-3476(03)00454-2 PMID:14571236 DOI: https://doi.org/10.1067/S0022-3476(03)00454-2

Heppe Montero M, Gil-Prieto R, Walter S, et al. Burden of severe bronchiolitis in children up to 2 years of age in Spain from 2012 to 2017. Hum Vaccin Immunother. 2022;18(1):1883379. https://doi.org/10.1080/21645515.2021.1883379 PMID:33653212 DOI: https://doi.org/10.1080/21645515.2021.1883379

Sanchez-Luna M, Burgos-Pol R, Oyagüez I, et al. Cost-utility analysis of Palivizumab for Respiratory Syncytial Virus infection prophylaxis in preterm infants: update based on the clinical evidence in Spain. BMC Infect Dis. 2017;17(1):687. https://doi.org/10.1186/s12879-017-2803-0 PMID:29041909 DOI: https://doi.org/10.1186/s12879-017-2803-0

Martinón-Torres F, Carmo M, Platero L, et al. Clinical and economic burden of respiratory syncytial virus in Spanish children: the BARI study. BMC Infect Dis. 2022;22(1):759. https://doi.org/10.1186/s12879-022-07745-0 PMID:36175846 DOI: https://doi.org/10.1186/s12879-022-07745-0

Li X, Bilcke J, Vázquez Fernández L, et al; REspiratory Syncytial virus Consortium in EUrope (RESCEU) Investigators. Cost-effectiveness of respiratory syncytial virus disease prevention strategies: maternal vaccine versus seasonal or year-round monoclonal antibody program in Norwegian children. J Infect Dis. 2022;226(suppl 1):S95-S101. https://doi.org/10.1093/infdis/jiac064 PMID:35292816 DOI: https://doi.org/10.1093/infdis/jiac064

Coutts J, Fullarton J, Morris C, et al. Association between respiratory syncytial virus hospitalization in infancy and childhood asthma. Pediatr Pulmonol. 2020;55(5):1104-1110. https://doi.org/10.1002/ppul.24676 PMID:32040885 DOI: https://doi.org/10.1002/ppul.24676

ISTAT. Nati per giorno del mese e della settimana e per mese dell'anno - Anno di iscrizione 2021. Online https://demo.istat.it/altridati/IscrittiNascita/index.html. (Accessed June 2024) http://dati.istat.it/

Schauer U, Hoffjan S, Bittscheidt J, et al. RSV bronchiolitis and risk of wheeze and allergic sensitization in the first year of life. Eur Respir J. 2002;20(5):1277-1283. https://doi.org/10.1183/09031936.02.00019902 PMID:12449185 DOI: https://doi.org/10.1183/09031936.02.00019902

Escobar GJ, Masaquel AS, Li SX, et al. Persistent recurring wheezing in the fifth year of life after laboratory-confirmed, medically attended respiratory syncytial virus infection in infancy. BMC Pediatr. 2013;13(1):97. https://doi.org/10.1186/1471-2431-13-97 PMID:23782528 DOI: https://doi.org/10.1186/1471-2431-13-97

ISTAT. Tavole di mortalità: singole età. 2021. Online http://dati.istat.it/Index.aspx?DataSetCode=DCIS_MORTALITA1. (Accessed June 2024)

Ministero della salute. Progetto Mattoni SSN. Pronto Soccorso e sistema 118. Proposta metodologica per la valutazione dei costi dell’emergenza. Online http://www.mattoni.salute.gov.it/mattoni/documenti/11_Valutazione_costi_dell_emergenza.pdf. (Accessed June 2024)

Decreto del Ministero della Salute 18 ottobre 2012. Tariffe delle prestazioni di assistenza specialistica ambulatoriale. Online http://www.trovanorme.salute.gov.it/norme/renderPdf.spring?seriegu=SG&datagu=28/01/2013&redaz=13A00528&artp=3&art=1&subart=1&subart1=10&vers=1&prog=001. (Accessed June 2024)

AIFA. Linee guida per la compilazione del Dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale ai sensi del D.M. 2 agosto 2019.; Online https://www.aifa.gov.it/documents/20142/1283800/Linee_guida_dossier_domanda_rimborsabilita.pdf. (Accessed June 2024)

Calabria S, Ronconi G, Dondi L, et al. Analisi real-world dei disturbi ostruttivi delle vie respiratorie: caratterizzazione, assistenza sanitaria e costi. Recenti Prog Med. 2021;112(4):285-293. PMID:33877089

OECD. Online https://www.oecd.org/italy/PAG2019-ITA_it.pdf. (Accessed June 2024) https://www.aranagenzia.it/attachments/article/9664/Italy-2019-OECD-economic-survey-overview.pdf

ISTAT. Average hourly earnings for employee jobs in the private sector in 2019. Online http://dati.istat.it/?lang=en. (Accessed June 2024)

OECD. Average usual weekly hours worked on the main job. Total age. Total employment. Total declared employment.; Online https://stats.oecd.org/Index.aspx?DataSetCode=ANHRS. (Accessed June 2024)

ISTAT. Employment rate 2020. Online http://dati.istat.it/Index.aspx?QueryId=25136&lang=en. (Accessed June 2024)

Gil-Prieto R, Pérez JJ, Drago G, et al. Modelling the potential clinical and economic impact of universal immunization with nirsevimab versus standard of practice for protecting all neonates and infants in their first respiratory syncytial virus season in Spain. BMC Infect Dis. 2024;24(1):924. https://doi.org/10.1186/s12879-024-09642-0 PMID:39242545 DOI: https://doi.org/10.1186/s12879-024-09642-0

Kobelt G, Jönsson L, Lindgren P, et al. Modeling the progression of rheumatoid arthritis: a two-country model to estimate costs and consequences of rheumatoid arthritis. Arthritis Rheum. 2002;46(9):2310-2319. https://doi.org/10.1002/art.10471 PMID:12355478 DOI: https://doi.org/10.1002/art.10471

Finelli L, Choi Y, Goldstein E. Number needed to immunize to prevent RSV with extended half-life monoclonal antibody. Vaccine. 2020;38(34):5474-5479. https://doi.org/10.1016/j.vaccine.2020.06.034 PMID:32600912 DOI: https://doi.org/10.1016/j.vaccine.2020.06.034

Lewis EN, Griffin MR, Szilagyi PG, et al. Childhood influenza: number needed to vaccinate to prevent 1 hospitalization or outpatient visit. Pediatrics. 2007;120(3):467-472. https://doi.org/10.1542/peds.2007-0167 PMID:17766517 DOI: https://doi.org/10.1542/peds.2007-0167

Palmu AA, Jokinen J, Nieminen H, et al. Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial. Vaccine. 2018;36(14):1816-1822. https://doi.org/10.1016/j.vaccine.2018.02.088 PMID:29503110 DOI: https://doi.org/10.1016/j.vaccine.2018.02.088

Fauroux B, Simões EAF, Checchia PA, et al. The burden and long-term respiratory morbidity associated with respiratory syncytial virus infection in early childhood. Infect Dis Ther. 2017;6(2):173-197. https://doi.org/10.1007/s40121-017-0151-4 PMID:28357706 DOI: https://doi.org/10.1007/s40121-017-0151-4

Scheltema NM, Nibbelke EE, Pouw J, et al. Respiratory syncytial virus prevention and asthma in healthy preterm infants: a randomized controlled trial. Lancet Respir Med. 2018;6(4):257-264. https://doi.org/10.1016/S2213-2600(18)30055-9 PMID:29500030 DOI: https://doi.org/10.1016/S2213-2600(18)30055-9

Korppi M, Piippo-Savolainen E, Korhonen K, et al. Respiratory morbidity 20 years after RSV infection in infancy. Pediatr Pulmonol. 2004;38(2):155-160. https://doi.org/10.1002/ppul.20058 PMID:15211700 DOI: https://doi.org/10.1002/ppul.20058

Sigurs N, Aljassim F, Kjellman B, et al. Asthma and allergy patterns over 18 years after severe RSV bronchiolitis in the first year of life. Thorax. 2010;65(12):1045-1052. https://doi.org/10.1136/thx.2009.121582 PMID:20581410 DOI: https://doi.org/10.1136/thx.2009.121582

Green CA, Yeates D, Goldacre A, et al. Admission to hospital for bronchiolitis in England: trends over five decades, geographical variation and association with perinatal characteristics and subsequent asthma. Arch Dis Child. 2016;101(2):140-146. https://doi.org/10.1136/archdischild-2015-308723 PMID:26342094 DOI: https://doi.org/10.1136/archdischild-2015-308723

Henderson J, Hilliard TN, Sherriff A, et al. Hospitalization for RSV bronchiolitis before 12 months of age and subsequent asthma, atopy and wheeze: a longitudinal birth cohort study. Pediatr Allergy Immunol. 2005;16(5):386-392. https://doi.org/10.1111/j.1399-3038.2005.00298.x PMID:16101930 DOI: https://doi.org/10.1111/j.1399-3038.2005.00298.x

López-Lacort M, Muñoz-Quiles C, Mira-Iglesias A, et al. Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024. Euro Surveill. 2024;29(6):2400046. https://doi.org/10.2807/1560-7917.ES.2024.29.6.2400046 PMID:38333937 DOI: https://doi.org/10.2807/1560-7917.ES.2024.29.6.2400046

Dirección Xeral de Saúde Pública. FOLLOW-UP REPORT ON IMMUNIZATION WITH NIRSEVIMAB IN GALICIA. Data up to week 52, 2024 (31-12-2023). Online https://assets-global.website-files.com/65774b0d3a50ee58b24dba82/65954eb228265f7f727f5707_Report_RSV_week52.pdf. (Accessed June 2024)

Região Autónoma da Madeira. Boletim de Imunização contra VSR - N.14. Online https://www.madeira.gov.pt//Portals/53/Documentos/GEVS/Boletim%2014_Imuniza%c3%a7%c3%a3o%20contra%20VSR.jpg. (Accessed June 2024)

Marcellusi AVR, Mecozzi A, et al. The direct and indirect cost of diabetes in Italy: a prevalence probabilistic approach. The European journal of health economics. HEPAC Health Econ Prev Care. 2014. doi: 10.1007/s10198-014-0660-y DOI: https://doi.org/10.1007/s10198-014-0660-y

Ernst C, Bejko D, Gaasch L, et al. Impact of nirsevimab prophylaxis on paediatric respiratory syncytial virus (RSV)-related hospitalizations during the initial 2023/24 season in Luxembourg. Euro Surveill. 2024;29(4):2400033. https://doi.org/10.2807/1560-7917.ES.2024.29.4.2400033 PMID:38275017 DOI: https://doi.org/10.2807/1560-7917.ES.2024.29.4.2400033

SIP. et al. Calendario vaccinale per la vita. 4° edizione 2019. Online https://www.simvim.org/wp-content/uploads/2019/08/Calendario-vaccinale-per-la-vita-4%C2%B0-edizione-2019.pdf. (Accessed June 2024)

Downloads

Additional Files

Published

2025-01-29

How to Cite

Marcellusi, A., Bini, C., Muzii, B., Soudani, S., Kieffer, A., Beuvelet, M., Bozzola, E., Midulla, F., Baraldi, E., Bonanni, P., Boccalini, S., & Orfeo, L. (2025). Economic and clinical burden associated with respiratory syncytial virus and impact of universal immunization with nirsevimab in Italy. Global and Regional Health Technology Assessment, 12(1), 16–28. https://doi.org/10.33393/grhta.2025.3182

Issue

Vol. 12 No. 1 (2025): January-December 2025

Section

Original Research Articles

Categories

License

Copyright (c) 2025 The authors

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

 

 

Received 2024-06-27
Accepted 2025-01-11
Published 2025-01-29

Metrics

Crossref
Scopus
Google Scholar
Europe PMC

Most read articles by the same author(s)

1 2 > >>