Sanofi is pausing orders for 50 milligram (mg) doses of respiratory syncytial virus (RSV) immunization nirsevimab (Beyfortus) and will have limited supply available when it reopens ordering.
The announcement comes as federal officials established payment rates for the long-awaited product to protect infants and young children from RSV.
Sanofi sent a letter to immunization providers saying there has been “unprecedented demand” for the new product. It plans to reopen its ordering system Nov. 16, but only customers with an allocation will be able to place a new order. Field representatives and customer service will update providers on the status of orders, shipping and potential allocation, according to Sanofi. A spokesperson said he does not expect opportunities to order outside allocation this season.
“Currently, due to demand, we are carefully managing distribution of the 50 mg doses in the private market to fulfill existing orders and to provide equitable access to remaining doses,” the spokesperson said.
Wholesalers and distributors will not receive additional shipments. Customers who typically use these channels will need to purchase directly through Sanofi if offered an allocation.
Sanofi previously announced it does not anticipate accepting new orders for the 100 mg formulation of nirsevimab this season. The company is working with the Centers for Disease Control and Prevention (CDC) to ensure equitable distribution of available doses through the Vaccines for Children program.
The CDC has issued interim recommendations on prioritizing nirsevimab for the youngest children and those most at risk of severe RSV disease this season.
The AAP will hold a webinar on nirsevimab supply and prioritization at 7 p.m. CST Nov. 8. Register here to attend.
Payment rates for nirsevimab
For immunization providers who are able to access nirsevimab, federal officials have established payment rates similar to other pediatric immunization administration services.
The Centers for Medicare & Medicaid Services (CMS) accepted the recommendation from the AAP to set the interim work relative value units (RVUs) at 0.24 work RVUs for Current Procedural Terminology (CPT) code 96380 and 0.17 work RVUs for CPT code 96381.
After factoring in practice expense and malpractice RVUs, the Medicare national payment rate for CPT code 96380 Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection, with counseling by physician or other qualified health care professional will be based on a total RVU of 0.68. The payment rate for CPT code 96381 Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection will be based on a total RVU of 0.59.
These national payment rates are further adjusted for any geographic variations associated with delivering the service. Pediatricians can find Medicare rates for their locality using the Physician Fee Schedule Look-up Tool.
The AAP advocated for the American Medical Association(AMA)/Specialty Society Relative Value Scale Update Committee (RUC) to recommend CMS set interim work RVUs for nirsevimab administration to expedite coding and payment for the service as the product hit the marketplace for use in the current RSV season. Payers now can move forward with setting appropriate payment rates for the monoclonal antibody.
The AAP expects to conduct a RUC survey of members on their experiences providing counseling for and/or administering the new product as part of the AMA RUC process for developing RVU recommendations. Recommendations approved by the RUC will be forwarded to CMS for consideration for payment under the Medicare Physician Fee Schedule starting Jan. 1, 2026.
- Addendum B of the Medicare Physician Fee Schedule CY2024 Final Rule lists the RVUs.
- The AAP will hold a webinar on nirsevimab supply and prioritization at 7 p.m. CST Nov. 8.
- CDC guidance on use of nirsevimab while supply is limited during the 2023-’24 season
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- Information for clinicians from the CDC on nirsevimab
- Information for parents from HealthyChildren.org on RSV immunization availability
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- Pediatrics in Review article “Implications of Food and Drug Administration Approval of Respiratory Syncytial Virus Prophylactic Medications”