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​Bebtelovimab

Important Information About Bebtelovimab

Bebtelovimab has received Emergency Use Authorization (EUA) allowing healthcare providers to administer bebtelovimab for outpatient treatment of mild to moderate COVID-19 in adults and children age 12 years and older, who are at high risk for progressing to severe COVID-19 and/or hospitalization and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Emergency Use Authorization of Bebtelovimab

On Feb. 11, 2022, Eli Lilly and Company received an EUA from the U.S. Food and Drug Administration (FDA) for its COVID-19 monoclonal antibody therapeutic bebtelovimab. Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Ordering Bebtelovimab

Lilly has established an ordering process for purchase of bebtelovimab with their distributor, AmerisourceBergen, that opens the week of August 15 (see the HHS update Bebtelovimab Commercial Transition for information on the final allocations of US government supplied bebtelovimab). Additional information on the ordering process for commercial bebtelovimab is included below and will be distributed to all sites of care that have previously ordered the product. A maximum order limit of 270 doses per week per provider site will be imposed. There will be no minimum order quantity. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Please note that to limit the potential for overstocking, no returns will be accepted for bebtelovimab.

To ensure your site has immediate access to purchase bebtelovimab, please see the ordering guidance below:

Existing AmerisourceBergen Accounts:

AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long term care facilities, clinics, etc. However, retail pharmacies will be excluded.

For any questions regarding product access, please contact c19therapies@amerisourcebergen.com

Sites Without an AmerisourceBergen Account:

To purchase bebtelovimab, your site must have a fully-vetted commercial account with AmerisourceBergen. To initiate the account creation process, please contact AmerisourceBergen at the following email address: asdaccountsetup@amerisourcebergen.com.

If you have any questions regarding the commercial purchase of bebtelovimab, please contact AmerisourceBergen at c19therapies@amerisourcebergen.com.

HPOP Reporting for Bebtelovimab

To maintain visibility on access to bebtelovimab and to keep the therapeutic locator up to date for the US population, reporting of ordering and utilization of commercially purchased product is desired. Details about how to report commercially purchased product inventory and administrations are still in development and will be shared when available.

Note that reporting inventory and administration of all US government-procured and distributed supply of bebtelovimab remains a requirement until all US government-procured bebtelovimab is consumed (a provider site's inventory is depleted). Please continue to log into your HPOP account to report twice each week, at minimum.

Payment and Cost Sharing

US Government-Procured Supply

Note that for government-procured supply, providers should only bill for the administration of the drug and should not include the monoclonal antibody product codes on these claims. If a site received the product for free, and internal systems require a product code to bill for the administration, sites should enter $0.01 for the billed amount.

Commercially-Procured Supply

For bebtelovimab product purchased commercially, sites should continue to use HCPCS codes:

  • Q0222: Injection, 175 mg for the product
  • M0222: Intravenous injection, includes injection and post administration monitoring
  • M0223: Intravenous injection, includes injection and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the covid-19 public health emergency
HCPCS Code HCPCS Short Descriptor Labeler Name National Payment Allowance Effective for Claims with DOS on or after 05/6/2021 National Payment Allowance Effective for Claims with DOS through 05/5/2021 Effective Dates
Q0222 Bebtelovimab 175 mg Eli Lilly $2,3941,2 Code not active during this time period 02/11/2022 – TBD
M0222 Bebtelovimab injection Eli Lilly $350.503 Code not active during this time period 02/11/2022 – TBD
M0223 Bebtelovimab injection (home) Eli Lilly $550.503 Code not active during this time period 02/11/2022 – TBD
  1. Providers shouldn't bill for the product if they received it for free through the USG-purchased inventory.
  2. Payment rate effective for dates of service on or after August 15, 2022. Providers should only bill Medicare for commercially-purchased products.
  3. These rates will be geographically adjusted for many providers. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for monoclonal antibody administration are included in the “Additional Resources” section below. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

No cost sharing (no copayment/coinsurance or deductible) for monoclonal antibody therapies to treat COVID-19 for people with Medicare fee-for-service and Medicare Advantage beneficiaries will be required for the duration of the calendar year in which the COVID-19 public health emergency ends.

For more information, please visit the following CMS sites:

Medicaid will pay for the cost of the bebtelovimab and its administration without the requirement for cost sharing through the last day of the first calendar quarter that begins one year after the last day of the Public Health Emergency. Under the American Rescue Plan Act of 2021 (ARP), state Medicaid programs cannot charge cost sharing on drugs to treat COVID-19 through the last day of the first calendar quarter that begins one year after the day that the PHE ends.

Bebtelovimab FDA EUA Resources

Bebtelovimab

 

Bebtelovimab

Hello, I am Dr. Michael Anderson.

I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID-19 therapeutics as well as focus on a pediatric response agenda. I want to talk about one of the therapeutics that can help people infected with COVID-19—bebtelovimab.

What is bebtelovimab?

Bebtelovimab is a monoclonal antibody used to help fight the coronavirus infection by blocking the virus from attaching to the body’s cells. This reduces the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for bebtelovimab?

Bebtelovimab is for adults and children 12 and older who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization or death. For more information about who is at high risk, please see the resources provided in the description.

Bebtelovimab is for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. Bebtelovimab is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 7 days of symptom onset.

How is bebtelovimab administered?

Bebtelovimab is given as an IV, or intravenous infusion. Patients however should be observed for 1 hour after infusion for any rare side allergic effects.

What are the limitations of use for bebtelovimab?

Bebtelovimab is not for everyone. It is not appropriate to start bebtelovimab if you are already hospitalized for COVID-19. Bebtelovimab is not for patients who require oxygen therapy due to COVID-19 or have an increase in their baseline O2 requirement. Drug-drug interactions for bebtelovimab are unlikely.

Bebtelovimab is one of several COVID-19 therapeutics. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

In this video, Michael Anderson, MD, MBA, senior advisor at ASPR, discusses the use of the monoclonal antibody b​ebtelovimab.

Bebtelovimab Frequently Asked Questions

Your body naturally produces proteins called antibodies to fight infections such as SARS-CoV-2, the virus that causes COVID-19. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens, such as viruses. Monoclonal antibodies prevent and treat COVID-19 by targeting the spike protein of SARS-CoV-2 to block the virus’ attachment and entry into human cells. Bebtelovimab is a COVID-19 monoclonal antibody.

The FDA granted EUA (Emergency Use Authorization) for the bebtelovimab COVID-19 therapy for adults and children (age 12 years and older weighing at least 40 kg) with mild to moderate COVID-19 symptoms and who are at high risk for progression to severe COVID-19.

Yes, a prescription from a qualified healthcare provider is required to be treated with bebtelovimab.

Lilly and the US government are actively engaging to develop a path forward for ensuring access of bebtelovimab for the under- and uninsured populations during the transition to commercialization. Clinical sites with an excess of bebtelovimab starting the week of August 15, 2022, should prioritize the US government-supplied drug for the under- and uninsured patients at their sites and use the commercially available supply for those with Medicare, Medicaid and private insurance.

While a full plan for under- and uninsured drug coverage is under development, a final allocation of USG-supplied bebtelovimab will be made available on September 6 to jurisdictions on a pro rata population basis. This supply can be shipped to state and territorial health departments for further distribution or direct shipment to clinical sites in their jurisdictions administering drug to under- and uninsured patients.

Thank you for your continued partnership in helping to ensure critical COVID-19 therapeutics reach communities across the country. We will keep you informed as additional details develop regarding the commercialization of bebtelovimab.