Regeneron, Lilly COVID-19 drugs' use plagued by reimbursement, staffing, testing

The use of monoclonal antibody therapies from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. to treat COVID-19 is being bogged down in the U.S. by reimbursement, staffing and testing problems, health officials said.

Only about 25% of the two companies' medicines that have been purchased by the U.S. government under the White House's Operation Warp Speed project are being used, officials told reporters during a Jan. 14 briefing.

The drugs, which are infused intravenously, are intended to treat mild to moderate symptoms of COVID-19 in nonhospitalized adults and adolescents as young as age 12 who are at high risk of progressing to severe disease or hospitalization. They are authorized in the U.S. for emergency use during the pandemic.

The Trump administration has purchased about 1.5 million treatment courses of Regeneron's antibody cocktail casirivimab and imdevimab, also known as REGN-COV2. Warp Speed signed a $450 million contract in July 2020 to obtain at least 300,000 doses of Regeneron's COVID-19 therapy, and on Jan. 12, it bought another 1.25 million treatment courses for $2.63 billion.

The Trump administration in October 2020 paid Lilly $375 million for 300,000 doses of its COVID-19 antibody drug bamlanivimab and bought another 650,000 additional doses Dec. 2, 2020, for $812.5 million.

The government could purchase up to 3 million doses in total from Lilly if needed, said John Redd, chief medical officer at the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

"So there is sufficient supply of these medications," Redd told reporters.

The drugs are available at no cost to U.S. patients — since taxpayers already footed the bill — though healthcare providers can charge for administering them and for the visits associated with their use, he said.

As of Jan. 13, about 660,000 treatment courses of both drugs had been assigned to states and territories, with about 500,000 of those delivered, Redd said.

Awareness

The reasons hospitals and outpatient facilities are not using the antibody therapies are "multifactorial," said Janet Woodcock, principal medical adviser to the U.S. Food and Drug Administration commissioner and Warp Speed's therapeutics lead.

"Some of it is public awareness," said Woodcock, who stepped aside in May 2020 from her role as director of the FDA's Center for Drug Evaluation and Research to join Warp Speed. She is expected to lead the FDA in an acting capacity once President-elect Joe Biden takes office while his yet-to-be-named pick for commissioner goes through the confirmation process.

Woodcock acknowledged the purpose of the Jan. 14 call with reporters was to promote the use of the Regeneron and Lilly COVID-19 drugs to the public and make people more aware of their availability. It is unusual for a high-level U.S. regulator to promote the use of specific medicines.

Staffing

The chief problem in administering the COVID-19 antibody drugs is the lack of staffing at hospitals and outpatient facilities, Woodcock said.

Because COVID-19 patients receiving the antibody medicines are infectious, facilities must have dedicated isolation rooms available. The infusions take about one hour and must be followed by an observation period of at least another hour.

Facilities "have to take nurses and other health care personnel who are working in the hospital, perhaps, and put them in a separate site where the infusions can be done," Woodcock said.

She noted that it takes "a lot of effort" to ensure people with COVID-19 receiving the antibody therapies are isolated from other patients, particularly at infusion centers where cancer patients and those with autoimmune diseases are being treated.

"Those are not the kind of people you want to mingle with infectious COVID patients," Woodcock said.

The federal government has put the onus and work on hospitals to "figure out this outpatient drug when hospitals are already stretched very thin," Erin Fox, senior pharmacy director at University of Utah Health, told S&P Global Market Intelligence in December 2020.

Hospitals are required to report to HHS the number of COVID-19 antibody therapy doses the facilities have administered or have on hand — another time-consuming burden the institutions must handle while simultaneously dealing with vaccinating people against the disease, Fox said.

Reimbursement

Reimbursement is a major issue that hospitals and infusion centers face in administering the COVID-19 antibody therapies, said Wes Hoyt, chief of operations at Hutchinson Regional Medical Center in Kansas.

"If you're not willing to accept a community benefit approach, then you may have to look at it from a financial aspect that says if I'm going to get reimbursed and the codes aren't in the system to get reimbursed, you're going to eat all of that cost until they get it figured out and that could be significant," Hoyt told reporters. "Right now for us alone, we're in the hole over $100,000 for these infusions while we wait for codes to be entered into the governmental system. I can absorb that for a little while, but what if you're a smaller facility that would like to do this but you can't afford to do so?"

Testing

Another problem is COVID-19 patients must be treated with the antibody drugs early in their illness, and they are often unable to get test results back in time, making it too late to receive the medicines, Woodcock acknowledged.

"From everything we know about viral respiratory illnesses and about virus neutralization, the earlier you intervene, the better," she said. "We've heard from some regions and areas that testing may take three or four days and that may get them out of the 10-day window from their symptoms or make them very late, in which case, we would expect maybe you could not prevent hospitalization."

"The speed of testing and getting the test results back and getting the referral to go to an infusion center has been one of the bottlenecks," Woodcock said.