The AAP is urging federal health officials to provide immediate support for pediatricians to administer a new product to protect infants and toddlers from respiratory syncytial virus (RSV) and ensure equitable access.
“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,” AAP President Sandy L. Chung, M.D., FAAP, said in a statement. “But the truth is, we don’t have the infrastructure in place to ensure all children can access the product. And that is alarming.”
The Food and Drug Administration recently approved monoclonal antibody nirsevimab (Beyfortus) as a single injection for infants born during or entering their first RSV season and young children up to 24 months who remain at risk of severe disease in their second RSV season. The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices will meet Thursday to discuss whether to recommend nirsevimab and provide clinical guidance for its use.
RSV causes about 58,000 to 80,000 hospitalizations and 100 to 300 deaths per year in children under 5 years, according to CDC data. Nirsevimab has the potential to save lives and reduce suffering for thousands of infants. Clinical trial data from term and late preterm infants show it can reduce the risk of medically attended RSV by 75%. However, 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.
Dr. Chung sent a letter Monday to the leaders of the CDC and Centers for Medicare & Medicaid Services laying out some of the AAP’s concerns. Beyfortus is expected to cost about $300 to $500 per dose, which would mean large upfront costs to clinicians. Current Procedural Terminology codes do not allow practices to bill appropriately for counseling families and administering the drug, meaning practices initially would have to provide it at a loss at the same time they are incurring upfront costs of COVID-19 vaccine commercialization. In addition, they could face staffing issues because some states restrict which types of medical staff can administer it.
The CDC may decide to include nirsevimab in the Vaccines for Children (VFC) program, which covers immunizations for children who are Medicaid-eligible, uninsured, underinsured or American Indian or Alaska Native. However, VFC products tend to have delayed availability, and there are strict rules on storage. Only 10% of birthing hospitals participate in the program.
In her letter, Dr. Chung asked health officials for a comprehensive strategy to ensure equitable access to the drug in hospitals, birthing centers and ambulatory practice settings as well as flexibilities in the VFC program. She laid out the following requests:
- increase bundled payment for normal newborn and specialty hospital care to account for the cost of nirsevimab;
- support birthing institutions so they can participate in the VFC program;
- support expedited consideration of a new immune globulin administration code for nirsevimab;
- encourage private insurance companies to expedite the addition of the new nirsevimab product code and administration code in their payment systems;
- allow stand-alone immunization counseling payment for both passive and active immunizations in VFC;
- raise the VFC maximum regional charges to account appropriately for immunization administration costs and include passive immunization products;
- assist pediatric practices with the financial impact of purchasing nirsevimab for privately insured children by allowing flexible borrowing and storage policies; and
- support the continued use of palivizumab for the prevention of RSV disease in high-risk infants for the upcoming season given the likely implementation challenges with nirsevimab.
“Pediatricians want to prevent disease. It’s a central tenet of pediatric health care,” Dr. Chung said. “But we need to make it feasible to offer this product. … 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.”
- AAP policy Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection
- Information from the AAP Red Book on RSV
- Information for clinicians from the CDC on RSV
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor