AAP to Federal Leaders: Immediate Support Needed for Pediatric Practices to Ensure All Children Can Benefit From New RSV Product

Pediatricians call on the Centers for Disease Control and Prevention and Centers for Medicare and Medicaid Services to provide the infrastructure supports needed to allow pediatricians to administer nirsevimab, which will be discussed Aug. 3 by a CDC panel of experts   

ITASCA, IL – In anticipation of an Aug. 3 meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) urges federal leaders who oversee the immunizations of millions of U.S. children to rapidly implement the changes that will be needed to ensure all children can access a product that can prevent RSV, a virus that infects thousands of children each year. 

Nirsevimab, which has been approved by the FDA under the brand name Beyfortus, is a monoclonal antibody that was shown to reduce the risk of medically attended cases of RSV by 75% in clinical trials. On Aug. 3, the ACIP will consider proposed recommendations to offer it to all infants in their first year of life and to older babies at high risk.  

If approved by the ACIP and CDC, nirsevimab has the potential to save lives and reduce suffering for thousands of infants. But getting it to all U.S. infants will be a monumental undertaking for a pediatric health care system already burdened by financial and logistical challenges, according to AAP President Sandy Chung, MD, FAAP.  

“When I talk with pediatricians about this product, I hear a mixture of both hope and despair,” Dr. Chung said. “We have cared for children with RSV and have seen how devastating it can be, and so the chance to help infants build up immunity to the virus is a great advancement in pediatric health care. But the truth is, we don’t have the infrastructure in place to ensure all children can access the product. And that is alarming.”  

In her letter to Mandy K. Cohen, MD, MPH, Director of the CDC and Chiquita Brooks-LaSure, Administrator of the Centers for Medicare and Medicaid Services (CMS), Dr. Chung said families living in lower-income and under-resourced communities, as well as those with infants at greatest risk for severe RSV illness, may face challenges accessing nirsevimab unless significant changes are made in the systems used to deliver immune-boosting products.  

AAP calls for a comprehensive strategy to ensure equitable access to nirsevimab in hospitals, birthing centers and ambulatory practice settings. That includes adding the cost of nirsevimab to bundled payment for newborns in hospitals and ensuring hospitals stock the product so that infants born during RSV season can receive it before they leave the hospital.  

Assuming ACIP votes to recommend nirsevimab be included in the Vaccines for Children program, AAP recommends changes to encourage more providers – including birthing centers and hospitals – to participate in VFC. Currently, only 10% of birthing hospitals participate in VFC, which covers the cost of immunizations for nearly half of children in the U.S., including children on Medicaid and children who have no health insurance, whose insurance doesn’t cover immunizations, or who are American Indian or Alaska Native. That means many VFC-eligible children born in hospitals or birthing centers may not be able to access nirsevimab immediately after birth.  

Other challenges exist in administering nirsevimab in ambulatory practice settings, including:  

• Pediatrician practices are already bracing for the impact of COVID-19 vaccine commercialization, which will involve upfront costs and new logistics to manage. Nirsevimab does not yet have codes to allow practices to appropriately bill for counseling families and administering it. This means practices would provide this product at a loss during a time when many do not have the overhead to do so.
• Since nirsevimab is a monoclonal antibody, in some states it will require more highly trained clinical staff to administer it. Many private practices would have to hire staff or incur other costly staffing changes.
• The anticipated high cost of Beyfortus ($300-$500 per dose) means pediatric practices would incur large upfront costs to purchase the product, as well as additional refrigerators to store it, with uncertainty around how many parents will ultimately accept it for their infants. Payment from insurance companies for new products often lags 6 to 12 months after they are administered. 
• Currently VFC-funded products must be purchased and stored separately. AAP is advocating for greater flexibility to borrow between VFC and private-payer stocks to reduce financial risks to practices.
• VFC-funded product is likely to be available later than privately funded products, which will lead to delays in some children being able to receive protection. 

“Pediatricians want to prevent disease. It’s a central tenet of pediatric health care,” said Dr. Chung. “But we need to make it feasible to offer this product. What I am hearing from pediatricians is that they are already preparing for a fall that includes routine childhood immunizations, flu vaccine clinics, and additional costs to manage the commercialization of COVID-19 vaccine. While this product holds great promise against RSV, all children are not going to be able to equitably benefit unless our federal leaders offer strategic solutions to help.”   

###

The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.