Bebtelovimab is available under an emergency use authorization, and the HHS is making doses available to those who are uninsured and underinsured.
The Department of Health and Human Services (HHS) is launching an effort to help uninsured and underinsured Americans access the COVID-19 monoclonal antibody treatment bebtelovimab.
Developed Eli Lilly, bebtelovimab received FDA emergency use authorization in February 2022 to reduce hospitalization and death among patients who have a positive COVID-19 test and who 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.
The U.S. government has purchased more than 750,000 doses of the product, HHS said in a news release.
“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,” HHS said.
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.
Eli Lilly and Company said in a news release in July that it will supply an additional 150,000 doses of bebtelovimab.
Now, HHS is making 60,000 doses of the product available to support the bebtelovimab product replacement initiative. Through this new initiative — 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, the agency said.
“Healthcare 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,” HHS added.
At the current rate of use, the additional doses purchased for this initiative are expected to be available through September 2023.
HHS initiated the program because around 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,” HHS said.
Laboratory data has indicated that bebtelovimab retains efficacy with a broad range of COVID variants, including omicron BA.2, Blue Cross said in an April notice.