Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Dec;103(12):1163-1167.
doi: 10.1136/archdischild-2018-315349. Epub 2018 Sep 14.

Neonatal outcomes following new reimbursement limitations on palivizumab in Italy

Valeria Belleudi  1 , Francesco Trotta  1 , Luigi Pinnarelli  1 , Marina Davoli  1 , Antonio Addis  1
Affiliations

Neonatal outcomes following new reimbursement limitations on palivizumab in Italy

Valeria Belleudi et al. Arch Dis Child. 2018 Dec.

Abstract

Objective: To evaluate the impact of new reimbursement decisions for palivizumab treatment on respiratory syncytial virus (RSV) hospitalisations and the concomitant number of palivizumab prescriptions for infants aged <2 years.

Design: We compared the RSV hospitalisation rates in infants before and after implementation of new limitations during three RSV seasons 2014-2017.

Setting: Population aged <2 years at the beginning of each RSV seasons extracted from regional health systems (Lazio region, 2016, 5 898 124 inhabitants and 47 595 births).

Patients: Out of 70 323 infants, 5895 (8.4%) premature babies (gestational age (GA) <37 weeks) were followed before-after Italian Medicines Agency (AIFA)-2016 limitations.

Intervention: In 2016, AIFA, following the American Academy of Pediatrics guidelines, decided to limit coverage of palivizumab prophylaxis (GA ≤29 weeks).

Main outcomes measures: Trend of hospitalisations by months and rate of RSV before-after new restrictions were analysed. Palivizumab prescriptions and costs for National Health Service (NHS) were considered.

Results: In a population of 284 902 aged <2 years, the number of hospitalisations due to RSV infection was 1729. Following AIFA-2016 limitations, a reduction in the number of RSV infection-based hospitalisations from 6.3/1000 (95% CI 6.0 to 6.7) to 5.5/1000 (95% CI 5.0 to 5.9) was observed. Palivizumab showed a concomitant reduction of 48% in the number of prescriptions (saving €750 000 for the NHS). No differences of GA, age on admission or severity of RSV infection were observed.

Conclusions: Implementation of the new palivizumab reimbursement criteria was not associated with an increase in the RSV hospitalisation rate for children aged <2 years despite a significant reduction in the number of palivizumab prescriptions.

Keywords: impact of regulatory decisions; palivizumab; pediatric hospitalization; premature infant; respiratory syncytial virus.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Hospitalisations for infection by the respiratory syncytial virus (RSV) and other respiratory viruses (ORV) before and after Italian Medicines Agency (AIFA)-2016 limitations.
Figure 2
Figure 2
Prevalence of infection by the respiratory syncytial virus before and after Italian Medicines Agency-2016 limitations.
Figure 3
Figure 3
Number of palivizumab prescriptions before and after Italian Medicines Agency (AIFA)-2016 limitations.
See this image and copyright information in PMC

References

    1. 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;5:271–98. 10.1007/s40121-016-0123-0 - DOI - PMC - PubMed
    1. Frassanito A, Nicolai A, Nenna R, et al. . Acute viral respiratory tract infections and wheezing at follow-up in children. Eur Respir J 2015;46(Suppl 59):PA1319.
    1. Ferrara M, Cangiano G, Papasso S, et al. . Bronchiolitis: a 9 years epidemic seasons analysis. Eur Respir J 2014;44(Suppl 58):P1258.
    1. Zuccotti G, Dilillo D, Zappa A, et al. . Epidemiological and clinical features of respiratory viral infections in hospitalized children during the circulation of influenza virus A(H1N1) 2009. Influenza Other Respir Viruses 2011;5:e528–34. 10.1111/j.1750-2659.2011.00264.x - DOI - PMC - PubMed
    1. Corsello G, Di Carlo P, Salsa L, et al. . Respiratory syncytial virus infection in a Sicilian pediatric population: risk factors, epidemiology, and severity. Allergy Asthma Proc 2008;29:205–10. 10.2500/aap.2008.29.3101 - DOI - PubMed

MeSH terms