CC BY-NC-ND 4.0 · Am J Perinatol 2020; 37(02): 174-183
DOI: 10.1055/s-0039-1694008
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Impact of the 2014 American Academy of Pediatrics Immunoprophylaxis Policy on the Rate, Severity, and Cost of Respiratory Syncytial Virus Hospitalizations among Preterm Infants

Leonard R. Krilov
1   Division of Pediatric Infectious Disease, Children's Medical Center, NYU Winthrop Hospital, Mineola, New York
,
Jaime Fergie
2   Department of Pediatric Infectious Disease, Driscoll Children's Hospital, Corpus Christi, Texas
,
Mitchell Goldstein
3   Division of Neonatal Medicine, Loma Linda University Children's Hospital, Loma Linda, California
,
Lance Brannman
4   AstraZeneca, Gaithersburg, Maryland
› Author Affiliations
Funding This study was supported by AstraZeneca (the manufacturer of palivizumab), which owned the U.S. rights to palivizumab at the time this work was completed. The U.S. rights to palivizumab are currently owned by Swedish Orphan Biovitrum AB.
Further Information

Publication History

17 January 2019

24 June 2019

Publication Date:
20 August 2019 (online)

Abstract

Objective This study examined the rate, severity, and cost of respiratory syncytial virus (RSV) hospitalizations among preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after a 2014 change in the American Academy of Pediatrics policy for RSV immunoprophylaxis.

Study Design Preterm (29–34 wGA) and term infants born from July 2011 to March 2017 and aged < 6 months were identified in a U.S. commercial administrative claims database. RSV hospitalization (RSVH) rate ratios, severity, and costs were evaluated for the 2011 to 2014 and 2014 to 2017 RSV seasons. Postpolicy changes in RSVH risks for preterm versus term infants were assessed with difference-in-difference (DID) modeling to control for patient characteristics and temporal trends.

Results In the DID analysis, prematurity-associated RSVH risk was 55% greater in 2014 to 2017 versus 2011 to 2014 (relative risk = 1.55, 95% confidence interval: 1.10–2.17, p = 0.011). RSVH severity increased among preterm infants after 2014 and was highest among those aged < 3 months. Differences in mean RSVH costs for preterm infants in 2014 to 2017 versus 2011 to 2014 were not statistically significant.

Conclusion RSVH risk for preterm versus term infants increased after the policy change, confirming previous national analyses. RSVHs after the policy change were more severe, particularly among younger preterm infants.

Supplementary Material

 
  • References

  • 1 Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G. Respiratory syncytial virus-associated hospitalizations among infants and young children in the United States, 1997-2006. Pediatr Infect Dis J 2012; 31 (01) 5-9
  • 2 Hall CB, Weinberg GA, Iwane MK. , et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009; 360 (06) 588-598
  • 3 Hall CB, Weinberg GA, Blumkin AK. , et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 2013; 132 (02) e341-e348
  • 4 American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134 (02) 415-420
  • 5 Anderson EJ, Krilov LR, DeVincenzo JP. , et al. SENTINEL1: an observational study of respiratory syncytial virus hospitalizations among U.S. infants born at 29 to 35 weeks' gestational age not receiving immunoprophylaxis. Am J Perinatol 2017; 34 (01) 51-61
  • 6 Anderson EJ, Carbonell-Estrany X, Blanken M. , et al. Burden of severe respiratory syncytial virus disease among 33–35 weeks' gestational age infants born during multiple respiratory syncytial virus seasons. Pediatr Infect Dis J 2017; 36 (02) 160-167
  • 7 García CG, Bhore R, Soriano-Fallas A. , et al. Risk factors in children hospitalized with RSV bronchiolitis versus non-RSV bronchiolitis. Pediatrics 2010; 126 (06) e1453-e1460
  • 8 Simões EA, Anderson EJ, Wu X, Ambrose CS. Effects of chronologic age and young child exposure on respiratory syncytial virus disease among US preterm infants born at 32 to 35 weeks gestation. PLoS One 2016; 11 (11) e0166226
  • 9 Rajah B, Sánchez PJ, Garcia-Maurino C, Leber A, Ramilo O, Mejias A. Impact of the updated guidance for palivizumab prophylaxis against respiratory syncytial virus infection: a single center experience. J Pediatr 2017; 181: 183-188
  • 10 The IMpact Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998; 102 (03) 531-537
  • 11 Synagis (palivizumab) [package insert]. Gaithersburg, MD: MedImmune; 2017
  • 12 American Academy of Pediatrics Committee on Infectious Diseases and Committee on Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics 1998; 102 (05) 1211-1216
  • 13 Respiratory syncytial virus. In: Pickering LK. , ed. Red Book: 2000 Report of the Committee on Infectious Diseases, 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000: 483-487
  • 14 Respiratory syncytial virus. In: Pickering LK. , ed. Red Book: 2003 Report of the Committee on Infectious Diseases, 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003: 523-528
  • 15 Respiratory syncytial virus. In: Pickering LK. , ed. Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006: 560-566
  • 16 Respiratory syncytial virus. In: Pickering LK. , ed. Red Book: 2009 Report of the Committee on Infectious Diseases, 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009: 560-569
  • 17 Respiratory syncycital virus. In: Pickering LK. , ed. Red Book: 2012 Report of the Committee on Infectious Diseases, 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012: 609-618
  • 18 Munoz FM, Ralston SL, Meissner HC. RSV recommendations unchanged after review of new data. AAP News; 2017
  • 19 American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134 (02) e620-e638
  • 20 Kong AM, Krilov LR, Fergie J. , et al. The 2014–2015 national impact of the 2014 American Academy of Pediatrics guidance for respiratory syncytial virus immunoprophylaxis on preterm infants born in the United States. Am J Perinatol 2018; 35 (02) 192-200
  • 21 Blake SM, Tanaka D, Bendz LM, Staebler S, Brandon D. Evaluation of the financial and health burden of infants at risk for respiratory syncytial virus. Adv Neonatal Care 2017; 17 (04) 292-298
  • 22 Goldstein M, Krilov LR, Fergie J. , et al. Respiratory syncytial virus hospitalizations among U.S. preterm infants compared with term infants before and after the 2014 American Academy of Pediatrics guidance on immunoprophylaxis: 2012–2016. Am J Perinatol 2018; 35 (14) 1433-1442
  • 23 US Department of Labor, Bureau of Labor Statistics. Consumer Price Index. Medical Care. Series ID: SUUR0000SAM. Available at: http://data.bls.gov/cgi-bin/surveymost?su . Accessed April 23, 2018
  • 24 Dimick JB, Ryan AM. Methods for evaluating changes in health care policy: the difference-in-differences approach. JAMA 2014; 312 (22) 2401-2402
  • 25 Quick RD, Merkel K, Murphey DK, Fernandez M, Hauger SB. Impact of adopting 2014 guidance for palivizumab prophylaxis for children previously considered at high risk for severe respiratory syncytial virus disease. Int J Respir Pulm Med 2017 4(072)
  • 26 Grindeland CJ, Mauriello CT, Leedahl DD, Richter LM, Meyer AC. Association between updated guideline-based palivizumab administration and hospitalizations for respiratory syncytial virus infections. Pediatr Infect Dis J 2016; 35 (07) 728-732
  • 27 Ambrose CS. Statistical power to detect an association between guideline-based palivizumab administration and hospitalizations for respiratory syncytial virus infections. Pediatr Infect Dis J 2017; 36 (03) 348
  • 28 Farber HJ. Impact of the 2014 American Academy of Pediatrics guidance on respiratory syncytial virus and bronchiolitis hospitalization rates for infants born prematurely. J Pediatr 2017; 185: 250
  • 29 Texas Medicaid/CHIP Vendor Drug Program Fee-for-Service Medicaid Synagis Request Form, 2014–2015 Season. Available at: http://www.maxor.com/forms/IVSolutions/pdfs/lubbock/synagis/SMN-Tx%20Medicaid%20Vendor%20Drug%20091614-IVSL.pdf . Accessed February 20, 2019
  • 30 Boyce TG, Mellen BG, Mitchel Jr EF, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr 2000; 137 (06) 865-870
  • 31 Winterstein AG, Knox CA, Kubilis P, Hampp C. Appropriateness of age thresholds for respiratory syncytial virus immunoprophylaxis in moderate-preterm infants: a cohort study. JAMA Pediatr 2013; 167 (12) 1118-1124
  • 32 Forbes ML, Hall CB, Jackson A, Masaquel AS, Mahadevia PJ. Comparative costs of hospitalisation among infants at high risk for respiratory syncytial virus lower respiratory tract infection during the first year of life. J Med Econ 2010; 13 (01) 136-141
  • 33 McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. J Perinatol 2016; 36 (11) 990-996
  • 34 Fedor KL. Noninvasive respiratory support in infants and children. Respir Care 2017; 62 (06) 699-717
  • 35 Makari D, Staat MA, Henrickson KJ, Wu X, Ambrose CS. The underrecognized burden of respiratory syncytial virus among infants presenting to US emergency departments. Clin Pediatr (Phila) 2015; 54 (06) 594-597