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Bebtelovimab

Important Information About Bebtelovimab

On February 11, 2022, bebtelovimab received an 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. Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

On August 5, 2022, FDA updated the EUA for bebtelovimab to allow commercial marketing, and bebtelovimab has been commercially available since August 17, 2022. Prior to becoming commercially available, the federal government distributed more than 733,000 treatment courses to jurisdictions nationwide, and significant supplies of this product remain in many jurisdictions. This state-allocated supply should be used to treat patients who are uninsured or underinsured where it is available. On August 23, 2022, HHS launched the Bebtelovimab Product Replacement Initiative to help uninsured and underinsured patients access the product.

Ordering Bebtelovimab

Lilly has established an ordering process for the commercial purchase of bebtelovimab from their distributor, AmerisourceBergen. Commercial ordering opened August 17th (see the HHS update Bebtelovimab Commercial Transition for information on the final allocation of US government supplied bebtelovimab). Additional information on the ordering process for commercial bebtelovimab is included below. A maximum order limit of 270 doses per week per provider site will be imposed. There is 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

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.

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.

Batch Numbers for Bebtelovimab

Government Purchased Batch Numbers Commercially Purchased Batch Numbers
D476887 D534422
D476886
D487999
D480382
D488000
D492098
D494710
D493128
D533218

Bebtelovimab Product Replacement Initiative

On Friday, September 23, HHS launched the bebtelovimab product replacement initiative to help uninsured and underinsured Americans access bebtelovimab.

Since bebtelovimab received emergency use authorization from the FDA in February, HHS has purchased more than 750,000 doses of the product. While the last allocation of bebtelovimab from the federal supply to jurisdictions was made on Sept. 6th, HHS made 60,000 doses of the product available to support the bebtelovimab product replacement initiative. Through this new initiative, health care providers who use a commercially procured dose of bebtelovimab to treat an uninsured or underinsured patient may be eligible to have the dose replaced for free by HHS.

To qualify for a free replacement dose under this initiative, provider sites must meet the following criteria:

  • Have used all of their USG supply acquired through the HHS distribution program;
  • Have purchased commercial bebtelovimab and attest to using a purchased dose to treat an uninsured (has no insurance coverage and cannot afford treatment) or underinsured patient; and
  • Consider waiving or reducing the administration fee for bebtelovimab to be reasonable for that patient.

Health care providers now have three avenues for obtaining bebtelovimab:

  • For patients with Medicare, Medicaid or with private insurance who are not underinsured or for patients who can afford the treatment without insurance, health care providers should use commercially purchased product ordered directly from AmerisourceBergen.
  • For patients who are uninsured or underinsured, where a provider has already depleted their federal supply distributed through the state/jurisdiction and attests in HHS Health Partner Ordering Portal (HPOP) that they have administered a purchased dose to treat an uninsured or underinsured patient with administration fees waived or reduced (not greater than the CMS rate of $350.50/$550.50 for at-home visit), health care providers should use HPOP to request a bebtelovimab replacement dose.
  • For patients who are uninsured or underinsured, where the product replacement initiative is not used (including sites that are not able to purchase commercial bebtelovimab), health care providers should request doses from the supply that the federal government distributed to state/jurisdiction health departments.

Product replacements received under this initiative are indistinguishable from commercial product (have same lot numbers as commercially purchased product) and can be used to treat any patient. Payment is allowable for product received under this initiative.

Replacement only applies to commercially purchased product. The replacement dose is commercial supply and can be used on any patient, regardless of insurance status. Payment is allowable for doses received through this initiative.

At the current rate of use, HHS expects bebtelovimab to be available for the underinsured and uninsured through the replacement initiative through September 2023.

In addition to the bebtelovimab product replacement initiative, please note that of the more than 733,000 free doses of bebtelovimab that HHS has distributed to administration sites, a considerable amount remains available for free nationwide. Providers should use these free doses for uninsured and underinsured patients before requesting product replacements through the product replacement initiative.

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 bebtelovimab.

Bebtelovimab Frequently Asked Questions

The human 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/or 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 used to treat COVID-19.

FDA granted EUA for use of bebtelovimab in adults and children (ages 12 years and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19 and/or hospitalization and for whom alternative COVID-19 treatment options approved or authorized by the U.S. Food and Drug Administration (FDA) are not accessible or clinically appropriate.

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

Eli Lilly and HHS are working together to facilitate access to bebtelovimab for the underinsured and uninsured populations. 

As of September 19, 2022, approximately 530,000 doses of bebtelovimab have been administered to patients, which means that a considerable amount of free product remains in the field available to states and jurisdictions to treat uninsured and underinsured patients. In addition, all doses in the final allocation of the product on September 6, 2022, can be used to support sites of care that are serving underinsured and uninsured patients. State and territorial health officials manage that supply.

Additional product is available to health care providers through the Bebtelovimab Product Replacement Initiative specifically to replace commercially-purchased product that was used to treat an underinsured or uninsured patient.

There are three ways for administration sites to access bebtelovimab. Use the following decision tree for product access guidance.

decision tree image

Through the Bebtelovimab Replacement Initiative, healthcare providers treat their eligible uninsured or underinsured COVID-19 patients using the bebtelovimab the provider has purchased through commercial channels.

Using the Health Partner Ordering Portal (HPOP), the provider attests that the product has been provided to an uninsured or underinsured patient, and HHS sends a dose to replenish that used stock.

Providers can use their own established methods for determining uninsured or underinsured status, such as eligibility criteria for existing initiatives for which a patient may already be eligible (examples may include eligibility criteria used for the Advanced Premium Tax Credit (APTC) or for the State/Territory’s AIDS Drug Assistance Program (ADAP).

There are several different measures that could be used to determine if a patient in these categories is underinsured for the purposes of this initiative.

A patient is likely underinsured for the purposes of this initiative if any one of the following applies:

  • the patient has a household income less than $69,000 a year AND a deductible greater than $3000
  • the patient has household income less than $109,000 a year AND a deductible greater than $5000
  • Using the table below, if the patient’s health insurance deductible (Column C) is higher than the corresponding amount for household income (Columns A and B)
  • Using the table below, if the patient’s total out-of-pocket spending for medical care over the past 12 months (Columns D, E), including the cost of this treatment, is higher than the corresponding amount for household income. Out of pocket spending can include copays, deductibles, coinsurance, and the cost of the COVID-19 treatment bebtelovimab. Out of pocket spending generally does not include insurance premiums.

Table 1: Out-of-Pocket Amounts by Household Income

COLUMN A COLUMN B COLUMN C COLUMN D COLUMN E
Annual Household Income, ($) Monthly Household Income, ($) Is your deductible higher than: (Household Size of 1-2 people) (Household Size of 3 or more people)
Are your total out-of-pocket expenses for medical care over the past 12 months including the cost of this treatment, higher than:
$10,000-$19,000 $800-$1,600 $500 $500 $500
$20,000-$29,000 $1,700-$2,400 $1,000 $1,000 $1,000
$30,000-$39,000 $2,500-$3,300 $1,500 $3,000 $1,500
$40,000-$49,000 $3,300-$4,100 $2,000 $4,000 $2,000
$50,000-$59,000 $4,200-$4,900 $2,500 $5,000 $2,500
$60,000-$69,000 $5,000-$5,800 $3,000 $6,000
$70,000-$79,000 $5,800-$6,600 $3,500 $7,000
$80,000-$89,000 $6,700-$7,400 $4,000 $8,000
$90,000-$99,000 $7,500-$8,300 $4,500 $9,000
$100,000-$109,000 $8,300-$9,100 $5,000 $10,000
$110,000-$119,000 $9,200-$9,900 $5,500 $11,000
$120,000-$129,000 $10,000-$10,800 $6,000 $12,000
$130,000-$139,000 $10,800-$11,600 $6,500 $13,000
$140,000-$149,000 $11,700-$12,400 $7,000 $14,000

No. However, provider sites should consider waiving or reducing the administration fee for bebtelovimab to be reasonable for the patient being treated.

Yes; you will need to establish an account within the Health Partners Ordering Portal (HPOP). To do so, contact your state or territorial health department. If you need assistance identifying the appropriate contact, please contact us at COVID19Therapeutics@hhs.gov.

Only HPOP users have access to the Bebtelovimab Product Replacement Initiative at this time. Any provider not currently in HPOP should register through their state or territory to gain access for bebtelovimab ordering. If you need assistance identifying the appropriate contact, please contact us at COVID19Therapeutics@hhs.gov.

Each of the COVID-19 therapeutics and vaccines have unique paths and timelines to commercialization.

We do not currently expect to replicate this specific initiative for other therapeutics nor for vaccines. However, we do continue to work with each of the drug manufacturers to ensure there are specific plans in place to address anticipated gaps in access.

As we get closer to the commercialization transition for each product, we will share the details for those specific programs.

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