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Important Updates Regarding the Revised Emergency Use Authorization, Direct Order, and Reporting Process for REGEN-COV Monoclonal Antibody Therapy

August 5, 2021

The United States Food and Drug Administration (FDA) revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together), authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (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. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus – only after exposure to the virus. You can read more about the FDA’s revision here.

The federal government has developed a process for practitioners and facilities to order directly from the distributor, AmerisourceBergen (ABC). These details and resources are listed below. Facilities that may request resources may include hospitals, skilled nursing facilities, and long-term care facilities.

Process Overview

  • Facilities (based on classes of trade), are able to order REGEN-COV (Regeneron) monoclonal antibodies for their facilities.
  • Facilities will be required to:
    • Provide ABC with a board of pharmacy license or physician letter of authorization.
    • Attest to their designated class of trade and that they will administer the authorized product according to the terms of the FDA issued EUA.
    • Provide utilization data via either TeleTracking or Centers for the Disease Control and Prevention’s National Healthcare Safety Network (NHSN).
  • Facilities can order product based on established minimum amounts; subsequent orders are subject to a maximum amount based on previous orders and utilization.

Required Utilization Reporting

  • Weekly reporting on these therapeutics is required every Wednesday through the United States Department of Health and Human Services (HHS) Protect, TeleTracking, or NHSN depending on facility type.
  • Instructions are included at the bottom of the ABC order form and included here for reference.
    • To improve availability of treatments for Monoclonal Antibody (mAb) therapies for COVID-19 patients across the nation, the federal government requires entities receiving shipments of mAb treatments to provide weekly reports of mAb treatments administered and stocks on hand through one of the following reporting mechanisms:
      • For Hospitals, mAb therapeutic data reporting is included in the COVID-19 hospital data reporting as described in HHS FAQ/Guidance.
      • Skilled Nursing Facilities / Long Term Care Facilities are requested to provide data through the NHSN data system at a future date (guidance forthcoming).
      • All Additional Facilities such as Dialysis Centers, Home Health Services, Oncology, and Infusion Centers, are required to provide the requested data through the United States Health Care COVID-19 Portal.
  • First-time users will receive enrollment and reporting instructions in an e-mail from protect-noreply@hhs.gov with the subject line of 'Invitation: HHS TeleTracking COVID-19 Portal." This email provides step-by-step instructions to access the portal for the first time. If you do not receive an email in the next 48 hours, please contact TeleTracking's Technical Support at hhs-protect@teletracking.com.

Health care providers decide whether these investigational treatments are appropriate to treat COVID-19. Find facilities administering this treatment by using the National Infusion Center Locator.

Weekly Provider Conference Call Information

A conference call regarding HHS / ASPR Allocation, Distribution, and Administration of COVID-19 Therapeutics is held every Thursday, where health care providers can ask HHS questions regarding monoclonal antibodies.

Date: Thursday, August 5, 2021
Time: 2:00 - 2:30pm EST
Zoom Link: https://bit.ly/3rfRv4E

  • Meeting ID: 160 432 9034
  • Passcode: 897674

 

Additional Resources

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