November 7, 2020

HHS: 'Imminent' EUA for COVID-19 Antibody

In a special call on Friday, Nov. 6, the HHS announced that they anticipate an ‘imminent’ Emergency Use Authorization (EUA) for the Lilly COVID-19 antibody. 

This medication will be limited for individuals with confirmed COVID-19 disease, early in the course of their infection (likely within 7-10 days).

In phase 1, patients who have confirmed COVID + risk factors (such as age or BMI cut offs) will be eligible to receive an infusion of the antibody. The infusion is given via a standard IV over 1 hour in a monitored setting and patients will then need to be monitored for an additional hour, according to the HHS.

The amount of drug, distributed similarly to remdesivir, will be determined based on the number of hospitalizations and the number of positive tests in a state as reported to the HHS Protect database. The state will then distribute the drug to individual hospitals and hospital systems. Weekly shipments will begin as quickly as possible after the EUA. 

Reimbursement for the drug and infusion has not been fully decided, but it is likely the drug will be free, according to HHS officials. The infusion administration can be billed and information will be available on the CMS COVID page under FAQs. 

In phase 2, it is likely the drug will be available for all confirmed infected patients.

Many hospitals already have infusion sites Monday though Friday, however emergency departments may need to serve some role in these infusions. Pharmacies and other sites may be used, especially in the second phase. 

ACEP recommends that it would be prudent for emergency departments and hospitals to begin discussions about the appropriate site for these infusions. 

ACEP leaders remain in ongoing conversations with the HHS and will continue to update our members as new clinical information emerges.

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