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FDA Revokes Emergency Use Authorization for Bebtelovimab

• The FDA revoked the Emergency Use Authorization (EUA) for bebtelovimab 175mg on November 30, 2022, due to its diminished efficacy against emerging COVID-19 variants. • Bebtelovimab, a monoclonal antibody infusion treatment developed by Eli Lilly, was previously authorized for treating mild-to-moderate COVID-19 in certain high-risk patients. • Healthcare providers should discontinue the use of bebtelovimab and consider alternative treatments for COVID-19 that remain effective against current variants. • MaineCare coverage for bebtelovimab infusions ended on November 30, 2022, coinciding with the FDA's revocation of the EUA.

The Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorization (EUA) for bebtelovimab (175mg) on November 30, 2022. This decision was based on data indicating that bebtelovimab is no longer effective against certain emerging variants of COVID-19. Eli Lilly's bebtelovimab, a monoclonal antibody infusion treatment, had been authorized for use in treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

Impact on Treatment Protocols

With the EUA revoked, healthcare providers should immediately cease using bebtelovimab for COVID-19 treatment. Alternative therapies that retain efficacy against current variants should be considered. The FDA regularly updates its guidance on authorized treatments for COVID-19, and healthcare professionals are encouraged to consult these resources for the most current recommendations.

MaineCare Coverage

In conjunction with the FDA's decision, MaineCare ended coverage for bebtelovimab infusions on November 30, 2022. This includes codes Q0222 (Injection, bebtelovimab, 175 mg), M0222 (Intravenous injection, bebtelovimab, includes injection and post administration monitoring), and M0223 (Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence). These codes were active from August 15, 2022, to November 30, 2022.

Considerations for Providers

Providers with questions about the revocation or alternative treatment options are encouraged to contact their Provider Relations Specialist. It is crucial to stay informed about evolving COVID-19 treatment guidelines to ensure optimal patient care.
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Reference News

[1]
Emergency Use Authorization (EUA) Revoked for ...
maine.gov · Dec 22, 2022

The FDA revoked the Emergency Use Authorization for bebtelovimab, 175mg, effective November 30, 2022. This monoclonal an...

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