Update to Direct Ordering of Monoclonal Antibodies

As part of the U.S. Department of Health and Human Services (HHS) pandemic response efforts, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) oversees the allocation and distribution of COVID-19 therapeutics authorized by the U.S. Food and Drug Administration for emergency use. Two such monoclonal antibody therapies received Emergency Use Authorizations (EUA) in November for outpatient treatment of those diagnosed with mild to moderate cases of COVID-19 and meet the high-risk patient criteria noted within the EUAs. The two drugs were bamlanivimab (manufactured by Eli Lilly and Co.) and the therapeutic cocktail casirivimab/imdevimab (manufactured by Regeneron Pharmaceuticals, Inc.).

It is the goal of HHS to ensure fair and efficient access of monoclonal antibody treatments to the communities and facilities that need them. As such, HHS implemented a direct ordering system in January to complement our allocation process and offer treatment facilities the ability to quickly order monoclonal antibody treatments when they need them. There is no shortage in supply of these drugs, and we have enough on hand to meet the needs of all treatment facilities. For this reason, we are making both therapeutics (bamlanivimab and casirivimab/imdevimab) available through direct ordering only, as there is no longer a need for the federal government to allocate these drugs to health departments. All treatment sites meeting EUA requirements must now order bamlanivimab and casirivimab/imdevimab (when available for shipping) directly from AmerisourceBergen Corporation (ABC), the drugs’ sole distributor. The products remain free of charge to requesting sites.

HHS will continue to monitor all direct orders, and we retain the capacity to resume allocation of these and future therapies if needed. Treatment sites should review the direct ordering process guide and place orders directly with ABC at this site.

Please note that in addition to reporting therapeutics data in HHSProtect or the National Healthcare Safety Network, treatment sites wishing to place direct orders will be required to provide ABC with a board of pharmacy license or physician letter of authorization, attest to their designated class of trade, and ensure that product administration will be conducted according to the drugs’ EUAs.

Should you have any questions or concerns regarding the direct order process for COVID-19 monoclonal antibodies, you may contact HHS/ASPR at COVID19Therapeutics@hhs.gov or ABC at C19therapies@amerisourcebergen.com.