Study shows more than 158,000 administrations of deauthorized COVID-19 treatments

Key Takeaways:

• Despite being deauthorized by the FDA for their ineffectiveness against the omicron variant, two monoclonal antibody treatments for COVID-19 were administered more than 158,000 times in the United States since January 2022.
• The total cost of the deauthorized products likely exceeds $71 million, while they had “minimal likelihood of benefit” for omicron-infected patients, according to researchers.
• There may be several causes for the continual administration, including hospital unawareness and a lack of governmental guidance.

Despite being deauthorized by the FDA on Jan. 24, 2022, due to omicron variant inefficiency, two monoclonal antibody treatments were administered more than 158,000 times to patients with COVID-19, according to a study in JAMA Network Open.

“Our findings suggest that the use of deauthorized [monoclonal antibody (mAb)] products was widespread, even though patients had a minimal likelihood of benefit,” Timothy Anderson, MD, MAS, a clinician-investigator in the Center for Healthcare Delivery Science at Beth Israel Deaconess Medical Center, and colleagues wrote.

The antibody treatments, bamlanivimab-etesevimab and casirivimab-imdevimab, were first given emergency authorization by the FDA in early 2021 for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients.

Due to their activity against the omicron variant being “highly unlikely,” the FDA limited their usage to infections that are likely to have been caused by a variant that is susceptible to the treatments. Since omicron made up 99% of U.S. COVID-19 cases on Jan. 15, the odds of mAbs being necessary for treatment were miniscule, according to the FDA.

For the study, Anderson and colleagues used data from HHS to identify weekly trends in the administration of the mAb treatments before and after their deauthorization, from Oct. 27, 2021, through June 29, 2022, as well as individual state administration and usage of their remaining mAb supply.

The researchers reported that the administration of the mAb products peaked during the week of Dec. 22, 2021, with 91,036 total doses. While doses declined following FDA deauthorization, the proportion of COVID-19 cases for which mAbs were used peaked in March at 43 treatments per 1,000 cases.

In total, 158,395 doses were administered after deauthorization. Florida and New York accounted for 24% (>35,000) and 20% (>30,000) of total mAb treatments, respectively, while 11 states administered more than 50% of their remaining supply.

Factoring in Medicare payments for mAb administration — which can range from $450 to $750 per dose — Anderson and colleagues estimated that the total cost of the treatments likely exceeds $71 million.

Anderson and colleagues said the results “may reflect conflicting state government guidance, lack of hospital awareness of deauthorization or other factors.” They additionally referenced the FDA’s limiting of mAbs to applicable, yet rare, cases — instead of full deauthorization — as a misunderstanding and cause for continued administration.

The study was limited by a reliance on hospital reporting, which does not include other mAb administration sites, according to Anderson and colleagues. The researchers were also unable to explore individual facility administration because public data on mAb distribution are aggregated to the state level.

Anderson and colleagues acknowledged that the ramifications of the continued use of these treatments and the financial implications are unclear.

“Whether deauthorized treatments will be covered by payers and whether the FDA will take regulatory action against entities violating its guidance remains unknown,” they wrote.

References:

• Anderson T, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.28997.
• Administration of anti-SARS-CoV-2 monoclonal antibodies after US Food and Drug Administration deauthorization. https://www.eurekalert.org/news-releases/962937. Published Aug. 29, 2022. Accessed Aug. 30, 2022.
• Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the omicron variant. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron. Published Jan. 24, 2020. Accessed Aug. 31, 2022.