Am J Perinatol 2019; 36(S 02): S77-S82
DOI: 10.1055/s-0039-1691771
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Restricted Palivizumab Recommendations and the Impact on RSV Hospitalizations among Infants Born at > 29 Weeks of Gestational Age: An Italian Multicenter Study

Elena Priante*
1  Department of Woman's and Child's Health, Unit of Neonatal Intensive Care, University of Padua, Padua, Italy
,
Elena Tavella*
2  Division of Pediatrics and Neonatology, Department of Maternal and Infant Medicine, Nuovo Ospedale degli Infermi, ASL Biella, Italy
,
Elisa Girardi
3  Paediatrics and Neonatology, Hospital Villafranca di Verona, Italy
,
Maria Angela Militello
2  Division of Pediatrics and Neonatology, Department of Maternal and Infant Medicine, Nuovo Ospedale degli Infermi, ASL Biella, Italy
,
Veronica Mardegan
1  Department of Woman's and Child's Health, Unit of Neonatal Intensive Care, University of Padua, Padua, Italy
,
Milena M. Maule
4  Department of Medical Sciences, Cancer Epidemiology Unit, University of Turin, Turin, Italy
,
Alberto Dall'Agnola
5  Neonatology and Pediatric Infectious Disease, P. Pederzoli Hospital, Peschiera del Garda, Regione Veneto, Italy
,
Eugenio Baraldi
1  Department of Woman's and Child's Health, Unit of Neonatal Intensive Care, University of Padua, Padua, Italy
6  Respiratory Syncytial Virus Network (ReSViNET) Foundation, Zeist, The Netherlands
,
Paolo Manzoni
2  Division of Pediatrics and Neonatology, Department of Maternal and Infant Medicine, Nuovo Ospedale degli Infermi, ASL Biella, Italy
6  Respiratory Syncytial Virus Network (ReSViNET) Foundation, Zeist, The Netherlands
› Author Affiliations
Further Information

Publication History

Publication Date:
25 June 2019 (online)

Abstract

Objective Premature infants have the highest risk of being hospitalized with respiratory syncytial virus (RSV) infections. Palivizumab is the only licensed agent for RSVhospitalization (RSVH) prophylaxis in infants born at < 35 weeks of gestational age (wGA). In 2016, the Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) has restricted the eligibility for reimbursement to infants at high risk of RSVH, ruling out palivizumab administration for infants born at > 29 wGA. The aim of the present study was to compare the incidence of RSVH in two consecutive epidemic seasons (2015–2016 vs. 2016–2017), that is, before and after the new AIFA recommendations on palivizumab eligibility.

Study Design This was a noninterventional retrospective cohort study conducted at three neonatal intensive care units (NICUs) in northern Italy. Infants born at 29 and 35 wGA between March 15, 2015 and March 14, 2017 were enrolled for this study. Electronic medical charts were reviewed and parents were interviewed by telephone. Data were collected on neonatal course during NICU stay, palivizumab administration, and hospitalizations related to respiratory infections during the 1st year of life, comparing the infants born in season 1 with season 2.

Results Of 632 eligible infants, data were available for 536 (262 in season 1 and 274 in season 2). Overall, RSVH occurred 1.9 and 5.1% in infants in seasons 1 and 2, respectively (odds ratio [OR] = 2.77; 95% confidence interval [CI]: 0.98–7.8, p = 0.045). When the analysis was limited to patients not exposed to palivizumab, RSVHs were recorded for 1.8 and 5.9% infants in seasons 1 and 2, respectively (OR = 3.42; 95% CI: 0.96–12.20, p = 0.045). It is noteworthy that the incidence of hospital admissions for respiratory viruses other than RSV did not differ between the two seasons.

Conclusion Restricting eligibility for palivizumab reimbursement led to a significant increase in RSVH but had no impact on hospitalizations for other respiratory viruses. Future decisions on palivizumab prescription and coverage rules should be driven by a careful assessment of the cost-benefit ratio.