Medicare no longer will pay healthcare providers for administering the COVID-19 treatment bamlanivimab now that the FDA has revoked the Emergency Use Authorization for treatments in which the drug is administered alone.
Medicare will cover and pay for bamlanivimab, when administered alone, only for dates of service from Nov. 10, 2020 through April 16, 2021.
The FDA wrote that it has "has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use."
In a letter to Eli Lilly, the manufacturer of bamlanivimab, Denise Hinton, FDA chief scientist, cited the increasing prevalence of variants of the novel coronavirus and the risk that these variants are resistant to bamlanivimab as a sole treatment.
The FDA indicates that other monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and providers may continue using the following authorized therapies when administered together:
- Casirivimab and imdevimab
- Bamlanivimab and etesevimab
“While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a release.
“We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic.”