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Baby getting vaccine

New VFC program flexibilities may improve access to nirsevimab

October 3, 2023

New flexibilities in the Vaccines for Children (VFC) program may make it easier for pediatricians and hospitals to administer nirsevimab to infants to protect them from respiratory syncytial virus (RSV).

The Centers for Disease Control and Prevention (CDC) updated the provider agreement on inventory and borrowing rules, incorporating some of the strategies the AAP has been advocating for to ensure equitable access.

“CDC recognizes that some VFC providers may be challenged to maintain private stock of nirsevimab during the 2023-2024 respiratory virus season,” the agency said in its operations guide addendum. “CDC is continuing to explore operational policies that can help support these providers and will communicate any changes as soon as possible.”

RSV is the leading cause of infant hospitalization in the U.S. There are about 58,000 to 80,000 hospitalizations and 100 to 300 deaths per year in children under 5 years, according to CDC data.

Nirsevimab received CDC approval in early August for use in infants under 8 months and high-risk toddlers from 8-19 months. However, there are hurdles to administering it, including the cost of $495 in the private sector and $395 in the VFC program, which covers immunizations for children who are Medicaid-eligible, uninsured, underinsured, American Indian or Alaska Native. VFC participants traditionally must carry both VFC and private stock, which also can be a barrier. Only 10% of birthing hospitals participate in the program.

Under the new agreement, a provider who serves only Medicaid-eligible children is not required to purchase nirsevimab privately. If demand is low, VFC awardees can allow providers to order the minimum packaging of nirsevimab that is feasible, which may be a much lower quantity than other recommended vaccines.

“Because it is an expensive product, relaxing the requirement for VFC providers to also carry private stock this season is very helpful, as many private pediatric practices operate on very thin financial margins,” said Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases. “Purchasing an expensive product when payment from insurers is uncertain is not financially feasible for many practices.”

In addition, certain specialty providers like birthing facilities can offer a limited formulary of vaccines for the populations they serve based on the discretion of the awardee. VFC-enrolled birthing facilities offering nirsevimab should offer hepatitis B vaccine at birth and vice versa. Dr. O’Leary applauded this change as well.

“Clarifying that these birthing facilities could carry a limited inventory of products will hopefully encourage more of them to become VFC providers, which will help with access to this new immunization,” he said.

For the 2023-’24 season, the CDC also will allow borrowing between VFC and private stock of nirsevimab. Borrowed stock must be repaid dose-for-dose within one month or after five doses are borrowed (for small practices at the discretion of the awardee) and administered to the appropriate population. Awardees must receive proof of privately purchased doses that includes the number of doses, lot numbers and documentation that authenticates dose returned or doses repaid were administered to the appropriate recipients.

The CDC also is allowing VFC awardees to conduct virtual enrollment visits for specialty providers, including birthing facilities. These visits must be approved in writing (email) by VFC staff and meet certain requirements.

The AAP continues to advocate for policies that make it feasible for pediatricians and hospitals to administer nirsevimab. Dr. O’Leary called for increased latitude and clarity around VFC eligibility, especially since there is uncertainty about insurance status for many newborns. The AAP also has been urging new Current Procedural Terminology drug/therapeutic administration codes to cover counseling families and the full administrative work for a product such as nirsevimab.

Because nirsevimab may not be available this season, the AAP is recommending continued access to palivizumab for eligible high-risk infants and children in their first or second year of life.

Another new RSV product also is coming to the market. In late September, the CDC approved a maternal RSV vaccine, Pfizer’s RSVpreF (Abrysvo), to be given to pregnant people between 32-36 weeks’ gestation to protect their infants. Most infants whose mother receives the vaccine will not need nirsevimab, according to CDC guidance.

The AAP will host a town hall with the CDC director from noon to 1 p.m. CDT Oct. 4 to discuss nirsevimab and updated COVID-19 vaccines. AAP members can register here.



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