Important monoclonal antibody updates 

Posted on: 5/7/21

The Oklahoma State Department of Health has advised that HHS has been making contact with sites across the U.S to discuss potential reporting errors. Oklahoma has had 18 sites reporting utilization of standalone Bamlanivimab. 
  
On Feb. 25, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
  
On April 16, 2021, the FDA revoked the Emergency Use Authorization (EUA) for emergency use of bamlanivimab alone for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe Coronavirus Disease 2019 (COVID-19) and/or hospitalization.
  
OSDH asks hospitals to please ensure they are following the EUA by ensuring: (1) all providers have discontinued administration of Bamlanivimab without Etesvimab; (2) monocolonal antibody therapy administration consists of administration of Bamlanivimab and Etesevimab together for eligible patients. See fact sheet.
  
Additionally, ensure those responsible for submission of COVID-19 monoclonal antibody therapy data to HHS TeleTracking are entering the data accurately. 

For each of the products, enter in quantities of product remaining on hand and of product used in the last week.
• Quantity reported should be in patient courses.
• Bamlamivimab solo inventory should exclude bam part of bam/ete combos
• REMINDER: please report using “BAM/ETE” (not BAM)

OSDH has received questions regarding what sites can do if they have an abundance of mAbs and advised there are few options at this time. AmerisourceBergen has stated they do not currently have any plans for accepting any return product. As product expires, it can be discarded following standard procedures. You are encouraged to engage with your community, health departments, and testing entities to ensure no eligible patient goes without receiving this treatment. 
  
The Combat COVID HHS webpage contains copious COVID-19 information and has recently been updated and contains an infographic to share with the public on monoclonal antibody therapy. It is also available in Spanish.

Also, Regeneron has provided information about their Compassionate Use Policy. If you have a patient that you feel would benefit from the use of the Regeneron mAb therapy treatment, but they do not meet the eligibility requirements, compassionate use requests will be considered. Please click here for more information. (Patrice Greenawalt)