New AAP guidance for RSV drug spurs manufacturer reaction

The American Academy of Pediatrics (AAP) revision of its recommendations for use of palivizumab (Synagis, MedImmune Specialty Care Division of AstraZeneca) for respiratory syncytial virus (RSV) in infants has fueled a reaction from the drug’s manufacturer.

RSV is a common infection in young children and usually causes mild upper respiratory tract illness, but it can cause more severe disease in premature infants and those with chronic illnesses. Palivizumab is a monoclonal antibody that, through monthly injections, provides antibodies that help prevent a severe infection caused by RSV.

In a policy statement published in the August 2014 Pediatrics, “Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection,” and an accompanying technical report, both published online July 28, AAP said that based on a comprehensive review of the literature, the drug benefits few children other than very young premature infants and to infants with certain chronic illnesses such as congenital heart disease or chronic lung disease. In addition, AAP stated that overall advances in neonatal care since palivizumab was first licensed in 1998 mean that preterm infants are generally healthier and that hospitalization rates for RSV have gone down.

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AstraZeneca is responding with full-page newspaper ads across the country “to help educate the public on the issues at hand," according to AstraZeneca spokewoman Melissa Garcia.

“When we learned about the drastic reductions in patient eligibility proposed in the guidance and the potential impact on an estimated 140,000 babies that will be unable to receive access to preventive care if/when adopted by healthcare professionals, we felt it important to inform parents-including the half-a-million women who give birth prematurely each year-of the decisions being made that could impact the lives of their children,” Garcia said. 

“We are concerned that newly revised recommendations for RSV prevention contradict numerous studies and the generally accepted standard of care, and as a result, are putting children at risk,” she said.

Garcia also said that while the AAP’s recommendations are meant to be considered just that, “many insurance companies and public payers have historically quickly adopted them as their own eligibility parameters, and used the guidelines to deny children access to [palivizumab]. We anticipate that many Medicaid providers and private insurance companies will adopt these guidelines as well, as each denied infant presents significant cost savings for them,” she said. “These changes may eliminate more than 75% of premature infants who should be eligible according to the FDA-approved label-leaving 140,000 babies without access to critical preventive care each year.”

The AAP’s recommendations ignore efficacy data, according to Garcia, who cited data that show palivizumab reduces the rate of RSV-related hospitalizations in premature infants (≤35 weeks gestational age) by more than half vs placebo. A recent, randomized, placebo-controlled study published in the New England Journal of Medicine in 2013 showed an 82% reduction in RSV-related hospitalization among preterm infants 32 to 35 weeks gestational age.

“The recommendations are based on an understanding that rates of RSV hospitalization have declined in recent years, thus the need for prevention has declined,” Garcia said. “The data the committee reviewed, however, was data reflective of the entire infant population-the vast majority of whom are much better equipped to fight off RSV infection than preemies-rather than looking at the rates of RSV hospitalization within the population of infants who are actually eligible for [palivizumab].”

Dr. H. Cody Meissner, a member of an academy committee involved in drafting the new guidance was unavailable for comment.

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