Beyfortus Supply Shortages & CDC Guidelines

Beyfortus (nirsevimab) is a long-acting monoclonal antibody for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants approved by the U.S. Food and Drug Administration in July 2023. The MHA has heard significant concerns from members about the cost of purchasing and administering Beyfortus for infants entering their first RSV season since the drug was approved and has been working diligently to alleviate barriers.

The MHA sent letters to Blue Cross Blue Shield of Michigan (BCBSM) and the Michigan Association of Health Plans (MAHP) Oct. 23 to encourage coverage of Beyfortus so cost is not a barrier to adequate protection for the most vulnerable infants. Additionally, the MHA has engaged in conversations with the Michigan Department of Health and Human Services and the Medicaid health plans to confirm Beyfortus is covered through the federally funded Vaccines for Children program. Updates on coverage will be shared as soon as they become available.

The Centers for Disease Control and Prevention (CDC) released a Health Alert Network (HAN) advisory Oct. 23 providing guidance for clinicians in administering Beyfortus given current supply shortages. This follows release of a statement from Sanofi, Beyfortus’ manufacturer, indicating demand for the product has been higher than anticipated and supply has not kept pace, despite an aggressive supply plan.

The CDC’s interim recommendations for prioritizing Beyfortus administration include prioritizing administration of 100mg nirsevimab doses for:

  • Infants younger than six months old.
  • American Indian and Alaska Native infants younger than eight months old.
  • Infants between six to eight months with underlying health conditions that put them at high risk of severe RSV disease.

In addition, children eight to 19 months old should not receive nirsevimab, if they are eligible for palivizumab (Synagis). Lastly, providers should not utilize two, 50mg nirsevimab doses in lieu of one, 100mg dose for infants greater than 11 pounds.

Members may refer to the CDC HAN advisory for the complete recommendation. Members experiencing challenges with billing or reimbursement for Beyfortus administration should contact Kelsey Ostergren at the MHA.