COVID-19 Monoclonal Antibody Treatments

Frequently Asked Questions

I’m interested in providing monoclonal antibodies at my office. Is there a tool to help me estimate staffing needs and scheduling?

HHS in conjunction with John Hopkins university created a calculator to help potential sites identify staffing needs.

https://www.phe.gov/Preparedness/Pages/mabcalctool.aspx

Which monoclonal antibodies can be given subcutaneously?

At this time only REGN-COV2 may be given subcutaneously. A 1-hour observation period is required following administration of this product.

Is there a resource for REGN-COV packaging?

Yes, Regeneron has a number of resources available on their webpage.

https://www.regencov.com/Content/pdf/packaging-piece.pdf

Has the expiration date on the products in my inventory been extended?

The best source of information regarding extension of expiration dating is:

Please contact the manufacturer of your product if you have lot specific questions or are unable to find the information needed on the phe.gov webpage.

Can I give REGEN-COV or Bamlanivimab and eteseveimab as post-exposure prophylaxis?

Due to supply constraints, NIH recommends the prioritization of monoclonal antibodies for treatment of COVID-19 over post-exposure prophylaxis. Providers should consult the NIH treatment guidelines for further information regarding the prioritization of patients while supplies remain limited.

https://www.covid19treatmentguidelines.nih.gov/therapies/updated-statement-on-the-prioritization-of-anti-sars-cov-2-mabs/

Setting Up Your Facility to Provide Monoclonal Antibody Treatments

  1. Review the Health and Human Services checklist for Administering Monoclonal Antibody Treatments For COVID-19 in Your Facility and the U.S. Government’s Monoclonal Antibody Therapeutics Playbook for your site’s readiness.
  2.  Contact the state at COVID.Therapeutics@state.nm.us to receive registration information

Monoclonal Antibody Provider Required Reporting

Reporting of Monoclonal Antibody Inventory and Utilization

  • All sites are required to report their inventory and utilization weekly on Wednesday. The data impacts the states allocation from the federal government. The data is also used to ensure equitable allocation between facilities.
    • Non-hospital sites shall report monoclonal antibody inventories to both the federal government (utilizing their HHS Protect account) AND the state (utilizing ReadyOp Form). Reporting is conducted weekly on Wednesday from 8am to 12pm. Please note submissions before or after this time frame are not captured.
    • Hospitals shall report monoclonal antibody inventories to both the federal government and to the state utilizing their EMResource account. Reporting is conducted weekly on Wednesday and must be completed by noon.

Reporting Adverse Events

Reporting of serious adverse events and medication errors is required by the FDA.

Report serious adverse events to FDA MedWatch: https://www.fda.gov/media/76299/download

Monoclonal Antibody Distribution

Monoclonal antibodies are currently under allocation. The federal government allocates a portion of the available supply to each state on a bi-weekly cycle.

https://www.phe.gov/emergency/events/COVID19/therapeutics/distribution/Pages/data-tables.aspx

New Mexico Department of Health allocates product to participating facilities based on their reported utilization and inventory. Shipments are received by facilities once every two weeks.

How do I find a location offering monoclonal antibody treatments?

  • If you are being treated by a healthcare provider for COVID-19, please discuss treatment with them.
  • If you do not have a provider and are positive for COVID-19, contact the hospital in your community to inquire about treatment or use the COVID-19 Infusion Site Locator: https://covid.infusioncenter.org  

Providers: Claim, Add or Edit Your Infusion Center

Administration of Monoclonal Antibodies

Monoclonal antibodies must be administered in accordance with their current Emergency Use Authorizations (EUAs):

Directory of Monoclonal Antibody Sites

Patients can access available monoclonal antibody therapy providers by searching covid.infusioncenter.org

Claim your site:

  1. Upon receiving inventory, your site should be searchable on https://covid.infusioncenter.org/. Search for your site utilizing your zip code. Click the claim this location button and follow the directions.
      • You will be asked to provide your location name, website, phone number, fax number, website URL (if applicable), hours of operation, practice type & specialty, languages spoken, acceptance of external referrals, insurance plans accepted and available medications.
  2. If you are unable to find your location listed, please email covid19@infusioncenter.org the following information:
      • your location name, website, phone number, fax number, website URL (if applicable), hours of operation, practice type & specialty, languages spoken, acceptance of external referrals, insurance plans accepted, and available medications.
  3. Refer to the NICA Provider information sheet for more information. http://infusioncenter.org/wp-content/uploads/2021/03/How-To-Use-NICA-Locator_Providers_LinkedVersion.pdf

Billing of Monoclonal Antibodies

Emergency Monoclonal Antibody Orders

Emergency orders are available only to existing COVID-19 monoclonal antibody providers.

If a facility is at risk of running out of monoclonal antibodies between allocation cycles, an emergency request can be placed by contacting COVID.Therapeutics@state.nm.us. Please provide your location, current inventory, and daily utilization rate. The state emergency stock is small. Hospitals will be given priority for emergency medication orders. Emergency requests will be provided based on priority and availability of current inventory in the state emergency stock.

Weekly HHS Office Hours

New information regarding these therapeutics, administration and their distribution is provided weekly by the federal government. If you are interested in joining, please email COVID19Therapeutics@hhs.gov to request Zoom links.

 The Biweekly calls take place on Tuesdays (2:00 – 3:00PM ET) and Thursdays (2:00 – 3:00PM ET)

Additional Resources

Health and Human Services (HHS) has numerous toolkits with information ranging from administration resources, clinical evidence summaries, patient education resources, COVID-19 variant proportion data, and frequently asked questions to payment resources. These tools are available through the HHS Public Health Emergency webpage:

https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx

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