HHS Announces Initiative to Help Uninsured and Underinsured Americans Access COVID-19 Monoclonal Antibody Treatment

Efforts will help smooth transition of outpatient treatment bebtelovimab to commercial marketplace

The U.S. Department of Health and Human Services (HHS) today announced a new effort to help uninsured and underinsured Americans access the COVID-19 monoclonal antibody treatment bebtelovimab even after the product became available on the commercial market last month.

Bebtelovimab received FDA emergency use authorization in February 2022. Since then, the U.S. government has purchased more than 750,000 doses of the product. Throughout the pandemic, bebtelovimab, along with other COVID-19 therapeutics, have been provided to states and territories for free. While the federal government has always expected that bebtelovimab and other COVID-19 therapeutics would ultimately transition to the commercial market, the timeline to make the transition for bebtelovimab has accelerated without additional funding from Congress. As a result, the federal procurement and distribution of bebtelovimab began to phase out and the product became available on the commercial market on August 17.

HHS is making 60,000 doses of the product available to support the bebtelovimab product replacement initiative. Through this new initiative, which is effective immediately, 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. Health care providers can use their own established methods for determining uninsured or underinsured status, such as eligibility criteria for existing programs for which a patient may already be eligible. At the current rate of use, the additional doses purchased for this initiative are expected to be available through September 2023.

Approximately 8% of Americans are not covered by a government insurance program such as Medicare or Medicaid or by private insurance. The Medicare and Medicaid programs fully cover all costs for bebtelovimab treatment, and the therapeutic is likely to be covered under most private health insurance plans.

Bebtelovimab is available under emergency use authorization from the U.S. Food and Drug Administration as a treatment product to reduce hospitalization and death among patients who have a positive COVID-19 test and are at high risk for progression to severe COVID-19 and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.