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Restricted Palivizumab Recommendations and the Impact on RSV Hospitalizations among Infants Born at > 29 Weeks of

Elena Priante1, Elena Tavella2, Elisa Girardi3

  • 1Department of Woman's and Child's Health, Unit of Neonatal Intensive Care, University of Padua, Padua, Italy.

American Journal of Perinatology
|June 26, 2019
PubMed

Insights

New Italian guidelines restricting palivizumab for premature infants significantly increased respiratory syncytial virus hospitalizations. This study highlights the need to re-evaluate palivizumab coverage for preventing RSVH in vulnerable infants.

Area of Science:

  • Neonatal Medicine
  • Infectious Diseases
  • Public Health Policy

Background:

  • Premature infants face the highest risk of respiratory syncytial virus (RSV) infections.
  • Palivizumab is the sole licensed prophylaxis for RSV hospitalization (RSVH) in infants born before 35 weeks gestational age (wGA).
  • In 2016, Italian drug agency (AIFA) restricted palivizumab reimbursement, excluding infants born after 29 wGA.

Purpose of the Study:

  • To compare the incidence of RSVH in premature infants before and after AIFA's 2016 policy change on palivizumab eligibility.
  • To assess the impact of restricted palivizumab access on RSVH rates in neonatal intensive care units (NICUs).

Main Methods:

  • A retrospective cohort study involving 536 infants born between 29 and 35 wGA across three NICUs in northern Italy.
  • Data collected via electronic medical records and parental interviews, comparing two consecutive RSV seasons (2015-2016 vs. 2016-2017).
  • Analysis focused on RSVH rates, palivizumab administration, and hospitalizations for other respiratory viruses.

Main Results:

  • RSVH incidence rose significantly from 1.9% in the pre-policy season to 5.1% in the post-policy season (OR=2.77, p=0.045).
  • Among infants not receiving palivizumab, RSVH rates increased from 1.8% to 5.9% (OR=3.42, p=0.045).
  • Hospital admissions for respiratory viruses other than RSV showed no significant difference between the two seasons.

Conclusions:

  • Restricting palivizumab reimbursement led to a significant increase in RSVH among eligible infants.
  • The policy change did not affect hospitalizations for other respiratory viruses, suggesting a specific impact on RSV.
  • Future palivizumab coverage decisions should prioritize cost-benefit analyses considering RSVH prevention in high-risk infants.
Abstract

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