HHS to Allocate Doses of Regeneron’s COVID-19 Antibody Therapy

HHS recently announced that it will allocate initial doses of Regeneron’s investigational monoclonal COVID-19 antibody therapy immediately.

Weekly allocations to state and territorial health departments have started based on confirmed COVID-19 cases in each state and territory over the previous seven days.

The federal department is promising to ensure fair distribution of the antibody therapy using a data-driven system. HHS will leverage data from hospitals and state health departments entered into the HHS Protect data collection platform.

“Authorization and distribution of this new Regeneron antibody treatment is another significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by Operation Warp Speed,” HHS Secretary Alex Azar said in the announcement. 

“Federal allocation of therapeutics like Regeneron’s, in cooperation with our state and local government partners, will help ensure that they go to the patients who need them the most, just days after the product is authorized,” he continued. 

The government-owned doses will be available at no cost to patients, but healthcare facilities could charge for administering the drugs. In mid-February, CMS created a billing code for reimbursement of these costs for Medicare providers.

At the beginning of July, HHS and the Department of Defense (DoD) announced an agreement with Regeneron to support large-scale manufacturing of casirivimab and imdevimab.

At the time, the government departments expected between 70,000 and 300,000 doses to become available through the agreement. The federal government stated it would allocate the doses to patients once Regeneron received FDA approval. 

Last week, FDA granted Regeneron emergency use authorization for the antibody cocktail that uses casirivimab and imdevimab to treat non-hospitalized patients 12 years and older, as long as they weigh at least 88 pounds.

Providers may also administer the drug combination to individuals who are at high risk of progressing to severe COVID-19 and to patients 65 years of age or older who have certain underlying conditions. 

But the cocktail is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, as the antibodies may generate worse clinical outcomes, the FDA warned. 

Under the emergency use authorization, the drugs must be administered together by intravenous (IV) infusion and in settings where healthcare providers have immediate access to medications to treat a severe infusion reaction, as well as space to minimize infection transmission.

“We are committed to the equitable and efficient distribution of resources like casirivimab and imdevimab to help prevent hospitalization from COVID-19 as much as possible,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, MD. 

“We are coordinating with Regeneron, its distributor, and state and territorial health departments to get therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic,” Kadlec stated.

Currently, researchers are evaluating casirivimab and imdevimab in an ongoing clinical trial as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, led by the National Institutes of Health with funding and other support from BARDA. 

According to early clinical trial data released in November, the antibody therapy has met primary and key secondary endpoints, significantly reducing viral loads and inpatient medical visits, including hospitalizations and visits to the emergency room, urgent care, and physician offices, including telemedicine visits. 

Specifically, treatment with the antibody cocktail reduced medical visits related to COVID-19 by 57 percent through Day 29 and reduced related medical visits by 72 percent in patients with one or more risk factors.

The treatment is the third COVID-19 therapeutic that HHS has provided allocation oversight. 

The first, remdesivir, gained FDA approval at the end of October and is now widely available. HHS began allocating initial doses of Eli Lilly & Company’s COVID-19 antibody treatment, LY-CoV555, last month.