Michelle Winokur, DrPH, and the AfPA Governmental Affairs Team, Alliance for Patient Access (AfPA)

RSV is the leading cause of hospitalizations among babies less than one year old. (1) Among high-risk infants, the virus is associated with prolonged intensive care and mechanical ventilation. (2) Preventive treatment, called palivizumab, decreases RSV-related hospitalizations and reduces infections by 55%. (3) Despite palivizumab’s effectiveness, health insurers regularly deny access to the treatment. 

In fact, a report card from the Institute for Patient Access shows commercial health plans reject 40% of prescriptions for infants born prematurely between 29 and 36 weeks’ gestation. Under Medicaid, prescriptions are rejected for one in four of these infants. (4) The report card is based on nationwide claims data from January through December 2019. “Insurers often cover preventive treatment only for the most premature, those born before 29 weeks gestation,” according to the report card. Even then, 25% of those severely premature babies have their palivizumab prescription rejected by a commercial insurance plan. (4) 

Health plans’ denial of preventive RSV therapy may stem from controversial guidelines issued by the American Academy of Pediatrics. 

In 2014, its Committee on Infectious Disease recommended limiting palivizumab to only severely premature infants born before 29 weeks gestation. This recommendation, however, is more limiting than the medication’s FDA label. Palivizumab is indicated for three groups: 

1. All babies with congenital heart disease
2. All premature infants born before 36 weeks gestation
3. Babies born before 32 weeks gestation with chronic lung disease 

Healthcare providers understand the FDA label and prescribe palivizumab for infants who need it. Health insurers that deny access to the therapy do so against providers’ medical judgment and knowledge of their patients’ health. 

Insurance denials leave babies vulnerable to contracting RSV, experiencing unnecessary hospitalization and susceptible to its long-term consequences. Meanwhile, parents are left reeling and unsure of how to proceed. Healthcare providers can support parents in the fight for access to preventive treatment, up to and including appealing insurance denials.

Parents should never have to fight for treatment that keeps their babies healthy. But insurers’ objections this winter make even less sense with hospitals strained from COVID-19 and ventilators scarce.

For almost a year, the nation has been focused on preventing the spread of coronavirus. While that is still important, let us not forego opportunities to protect vulnerable infants from RSV since a preventive treatment is available.

References:

1. Nair H, Nokes DJ, Gessner BD et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet May 1 2015; 375(9725):1545- 55.
2. Doucette A, Jiang X, Fryzek J et al. Trends in respiratory syncytial virus and bronchiolitis hospitalization rates in highrisk infants in a United States Nationally Representative Database, 1997-2012. PLoS One 2016; 11:e0152208.
3. 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 Sep 1998; 102(3 Pt 1):531-7
4. The Institute for Patient Access. National Access Report Card April 2020. Available from https://static1.squarespace. com/static/5523fcf7e4b0fef011e668e6/t/5ea741b3f943bc78 3bc27be1/1588019635451/IfPA-ReportCard-RSV-2020-National.pdf