The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / Perinatal Providers Stand by FDA Indication in New RSV Prevention Guidelines

Perinatal Providers Stand by FDA Indication in New RSV Prevention Guidelines

by Amanda Conschafter, blog editor

The National Perinatal Association’s 2015 guidelines for preventative RSV (respiratory syncytial virus) treatment send a clear message about protecting pre-term infants: the FDA indication stands. The guidance directly contrasts guidelines issued by the American Academy of Pediatrics earlier this year. AAP guidelines restricted access to only infants born before 29 weeks gestation, provoking outcry from health care providers about the risks that fragile infants will bear this RSV season.

The NPA guidelines reinforce the use of palivizumab, the preventative treatment against RSV, for at-risk infants born before 36 weeks gestation.   In a press release announcing the 2015 guidelines, the NPA noted that “Hospitalization is decreased by 55% for infants treated with palivizumab who were born prematurely at less than 36 weeks gestation who have chronic lung disease or bronchopulmonary dysplasia, and is decreased by 80%, for those born between 32-35 weeks’ gestation.”

Neonatologists, pediatricians, pulmonologists, pediatric critical care and infectious disease specialists were among the experts who weighed in on the guidelines’ development.

Mitchell Goldstein, M.D., the NPA guidelines’ primary author, has been an outspoken advocate for erring on the side of caution. In an opinion-editorial for the San Bernardino Sun, Dr. Goldstein argued that “My experience working on babies with these conditions convinces me that, whatever the cost-savings, restricting premature infants’ access to FDA-approved RSV prevention is not only risky but also borderline unethical.”

Susanne Tropez-Sims, M.D., a pediatrician in Nashville, Tennessee expressed similar concerns, citing worries about the disproportionate effect on African American babies. “Because African-American infants are more likely to be born prematurely, they bear the burden of this disease — and the risk of the AAP’s revised stance on access to preventive treatment,” Dr. Tropez-Sims explained.

Despite widespread concerns from health care providers, many state Medicaid offices have adopted the AAP’s guidelines into their coverage policies, limiting access by eliminating payment for palivizumab. Concerned health care providers wait to see how unprotected infants will fare between now and March, when RSV season ends in most states.

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