On Friday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) allowing the use of Gilead Sciences’ Remdesivir to treat COVID-19. Remdesivir is an antiviral drug that inhibits how a virus replicates. The drug has received this special authorization because it’s shown in an initial clinical trial to shorten the recovery time for severely impacted hospitalized patients with a confirmed or highly probable COVID-19 diagnosis. It does not prevent the disease and is not a vaccine.
What does the emergency use authorization mean?
The EUA allows for Remdesivir to be distributed in the U.S. and administered intravenously by health care providers to treat adults and children hospitalized with severe COVID-19. The EUA does not replace the normal FDA drug approval process that is required for Remdesivir.
How will the drug supply and distribution be managed?
The government will coordinate the donation and distribution of Remdesivir to hospitals in cities most heavily impacted by COVID-19. Hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of Remdesivir.
What steps is the drug manufacturer taking?
Gilead has donated the entirety of its existing supply of finished and unfinished product to help address the urgent medical needs posed by this pandemic. Gilead’s donation of 1.5 million individual doses of Remdesivir equates to more than 140,000 treatment courses that will be provided at no cost to treat patients following potential emergency authorizations and regulatory approvals. The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required.
What will Remdesivir cost?
The cost information is still unknown. According to Reuters, Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up.
What is the status of other possible treatments for COVID-19?
The FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). This status of other possible therapies can be viewed at the CTAP website.
What should employers do?
Continue to follow Remdesivir developments. We’ll learn more about the drug’s efficacy and Gilead’s pricing in the coming weeks. In the meantime, talk with your PBM about the steps they are taking to manage Remdesivir and other COVID-19 related drug costs.