Dear American Academy of Pediatrics Board Members:
As a group of practitioners dedicated to the care of children in the [XXXX] area, we would like to express
our concerns related to the rationing of care in our preterm infant population.
In past years, the American Academy of Pediatrics has suggested guidelines on the care of preterm infants
in relation to the prevention of serious RSV disease. As you are aware, the guidelines have become more
restrictive over time regarding who qualifies for prophylaxis. We are concerned that the most recent
guidelines represent a rationing of care on the grounds of cost, not a reasonable estimation of those who
may benefit from prophylaxis. This rationing increases the burden of disparity on those who are poor or
of African-American descent.
Scientific evidence supports the use of prophylaxis in the form of Palivizumab for those infants born less
than 35 completed weeks of age and less than 6 months at the start of RSV season, infants born below 28
completed weeks gestation and less than one year at the start of RSV season, those infants with chronic
lung disease and less than 2 years of age at the start of RSV season, and those infants born with
hemodynamically significant heart disease and less than two years of age at the start of RSV season.1,2
Studies have established safety and efficacy for these specific populations.
Since the inception of RSV prophylaxis with Palivizumab, research has clarified the use of the medication
for only those infants who will most benefit. Much of this research has focused on the 32-to-35 week
gestation infants, who have bared the brunt of prophylaxis rationing. Specifically, the PICNIC and FLIP
studies elucidated the incidence of serious RSV infection in this patient population and the physical and
environmental factors that increase the risks associated with being infected.3, 4, 5 Additionally, several
professional groups have presented at their national meetings and provided written guidance about the
risks associated with RSV disease in even the mildest of preterm infants. These include the Pediatric
Academic Societies 2009 Annual Meeting, the 2010 National Perinatal Association and The National
Medical Association 2010 Consensus Paper on Respiratory Syncytial Virus and African Americans.
Research on the incidence of serious RSV hospitalization on the younger preterm infants born from 28 to
32 weeks gestation has yielded data that again points to the need for prophylaxis to prevent serious
morbidity and mortality. Four studies found that, compared to 33-36 week gestation infants, 28-32 week
gestation infants were at 1.8- to 3.9-fold higher risk of RSV-related hospitalization; they were at 3.6- to
15.6-fold higher risk of RSV-related hospitalization than full term infants.6, 7, 8, 9, 10, 11
Research on the morbidity of serious RSV disease in the preterm infant is also introducing important data.
These studies highlight the long term effects correlated with having RSV disease in early infancy.
Morbidities such as recurrent wheeze, otitis media, apnea and even airway reconstruction have all been
reported.12, 13, 14, 15, 16, 17, 18 The potential for long term, serious adverse pulmonary health outcomes in
premature infants is higher than those of term infants.19 Research that evaluated early RSV infection in
otherwise healthy premature infants in Canada saw a significant difference in health care utilization with
increased hospitalizations, ICU lengths of stay, and ER and primary care visits. In this study, the RSV
infected preterm infant also had a significantly higher risk of death and even sudden unexplained death
than the control infants did. Following the science of this research and other studies like it, Canada
expanded its restrictive policy of dosing only those infants 28 completed weeks and younger to a more
appropriate, science-based policy.20
We do recognize the significant cost associated with giving Palivizumab to the preterm infant, and we
agree that it should be used only in instances supported by scientific evidence. Cost for a season of
Palivizumab prophylaxis has been reported from approximately $6,400 to over $25,000. 21, 22 A robust
analysis of Palivizumab performed in 2012, sponsored by MedImmune, concluded that monthly doses of
Palivizumab throughout the RSV season saved costs among infants less than 32 weeks gestational age.
The study also found that treatment was cost-effective in infants 32–34 weeks gestational age with 2009
AAP risk factors and infants 32-35 weeks Gestational Age with 2006 AAP risk factors. Palivizumab was
not cost-effective in 32-35 weeks Gestational Age infants with 1 or fewer risk factors.21
On the subject of cost analysis, we are also concerned that estimates do not realistically account for the
short-term peripheral costs, such as lost days of work for hospitalization, child care arrangements for
other children while the infant is in the hospital, travel, extra physician and ER visits, and medication and
equipment costs for ongoing complications. Additionally, no cost analysis looks at long-term
consequences, such as recurrent wheezing and airway remodeling, which research identifies as a result of
early RSV infection. These factors, in addition to first-hand experience working with this infant
population, demonstrate that prevention can far outweigh the cost savings of rationing care.
We ask that you carefully analyze all available literature and base the guidelines on a synthesis of the
scientific data that reflects an understanding of the consequences of not protecting infants from RSV. We
also request that you thoughtfully consider the diverse cultures and populations that we serve and ensure
that guidelines do not unfairly burden any member of our society.
Sincerely,
Name
Name
Affiliation
Affiliation
Address
Address
References
1. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal
antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants.
Pediatrics. 1998;102: 531-537.
2. Feltes TF, Cabalka AK, Meissner HC, et al; for 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.
3. Law BJ, Langley JM, Allen U, et al; The Pediatric Investigators Collaborative Network on Infections
in Canada Study of Predictors of Hospitalization for Respiratory Syncytial Virus Infection for Infants
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
Born at 33 Through 35 Completed Weeks of Gestation. The Pediatric Infectious Disease Journal
2004 23(9) 806-814
Simoes E, Carbonell-Estrany X, Fullarton JR, et al; A Predictive model for Respiratory Syncytial
Virus (RSV) Hospitalization of Premature Infants Born at 33-35 Weeks of Gestational Age, Based on
Data from the Spanish FLIP Study Respiratory Research 2008, 9:78
Figures-Aloy J, Quero-Jimnez J, Guzman-Cabanas J, et al; Risk Factors Linked to Respiratory
Syncytial Virus Infection Requiring Hospitalization in Premature Infants Born in Spain at a
Gestational Age of 32-35 Weeks The Pediatric Infectious Disease Journal 2008, 27 (9)788-793
Resch B et al. Rehospitalisations for respiratory disease and respiratory syncytial virus infection in
preterm infants of 29–36 weeks gestational age. Journal of Infection.2005;50:397–403.
Resch B et al. Rehospitalisations for respiratory disease and respiratory syncytial virus infection in
preterm infants of 29–36 weeks gestational age. Journal of Infection.2005;50:397–403.
Heikkinen T et al. Hospital admission of high risk infants for respiratory syncytial virus infection:
implications for palivizumab prophylaxis. Arch Dis Child Fetal Neonatal Ed. 2005; 90:F64–F68.
Park HW et al. Epidemiology of Respiratory Syncytial Virus Infection in Infants Born at Less Than
Thirty-Five Weeks of Gestational Age. Pediatr Infect Dis J. 2012;31:e99–e104.
Joffe S et al. Rehospitalization for Respiratory Syncytial Virus Among Premature infants. Pediatrics.
1999;104(7):894-899.
Berger TM et al. Prospective Population-based Study of RSV-related Intermediate Care and Intensive
Care Unit Admissions in Switzerland over a 4-Year Period (2001–2005). Infection. 2009;37:109–116.
Gouyon JB et al. Hospitalizations for respiratory syncytial virus bronchiolitis in preterm infants at
<33 weeks gestation without bronchopulmonary dysplasia: the CASTOR study. Epidemiol. Infect.
2013;141:816–826.
Sigurs N, Gustafsson P M , Bjarnason R, et al; Severe Respiratory Syncytial Viarus Bronchiolitis in
Infancy and Asthma and Allergy at Age 13. American Journal of Respiratory and Critical Care
Medicine. 2005 ; 171: 137-141
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. Pediatric
Allergy and Immunology. 2005; 386-392
Simoes E, Groothuis J, Carbonell-Estrany X. et al; Palivizumab Prophylaxis, Respiratory Syncytial
Virus, and Subsequent Recurrent wheezing. Journal of Pediatrics. 2007; 34-42
Kristajansson S; Increased prevalence of Otitis Media Following Respiratory Syncytial Virus
Infection. Acta Paediartica. 2009; 1-4
Snow A, Dayyat E, Montgomery-Downs HE, et al; Pediatric Pulmonology. 20091186-1191
Aljassim F, Robinson PD, Sigurs N, et al; A Whisper From the Silent Lung Zone. Pediatric
Pulmonology. 2009; 829-832
Emerick K, Cunningham M, Hartnick C; The Potential Impact of Palivizumab on Pediatric Airway
Reconstruction. American Journal of Otolaryngology 2006; 9-12
Colin A A, McEvoy C, Castile R; Respiratory Morbidity and Lung Function in Preterm Infants of 32
-36 Weeks Gestational Age. Pediatrics. 2010; 126:115-128
Samapalis J S; Morbidity and Mortality After RSV-Associated Hospitalizations Among Premature
Canadian Infants. Supplement to the Journal of Pediatrics. 2003; 143;s150-s156
Weiner LB et al. Cost-effectiveness analysis of palivizumab among pre-term infant populations
covered by Medicaid in the United States. J Med Econ.2012;15 (4):1-22.