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Federal officials are urging healthcare professionals and patients to use monoclonal antibody treatments to help stave off more severe COVID-19 illness, and have now set up three federally supported infusion sites.
In its push, the government also has posted an online locator for sites offering the therapies and is encouraging use at long-term care facilities and other alternative locations.
The United States has spent $375 million on Eli Lilly's bamlanivimab and $450 million on Regeneron's casirivimab plus imdevimab cocktail, and just agreed earlier this week to spend as much as $2.6 billion more on up to 1.25 million doses of that cocktail.
But almost 80% of the 660,000 doses that have been delivered by the two companies are still sitting on shelves, federal officials said in a press briefing Thursday. Doubts about efficacy, lack of resources to start up and staff infusion centers, questions on how to secure reimbursement, a lack of awareness, and no place to refer patients for infusions have all been barriers, said Janet Woodcock, MD, therapeutics lead on Operation Warp Speed, in the briefing.
Criteria for use might also be confusing. The therapies are urged for high-risk patients — anyone older than 65, and those age 12-65 years who have underlying conditions — and must be given "early" in the illness.
When asked to define "early," Woodcock said, "we don't have actual data on this," but said from previous knowledge of viral illnesses, the earlier the better. With COVID-19, that means within 10 days of symptoms and testing positive. Woodcock acknowledged that in some places it takes 3-4 days to get test results, which may delay diagnosis and thus treatment. "In that case we would expect maybe you could not prevent hospitalization," she said.
"The speed of testing — getting the test results and getting the referral going to an infusion center — has been one of the bottlenecks," Woodcock said.
New Federal Sites, Clearinghouse
The federal government has in the last few weeks helped three hospitals set up infusion centers in the West, where COVID-19 has been raging: El Centro Medical Center in El Centro, California; Tucson Medical Center in Tucson, Arizona; and Sunrise Hospital, in Las Vegas, Nevada.
Officials worked with hospitals to set up dedicated areas — in tents outside two of the hospitals, and in an observation wing of the other, said John Redd, MD, chief medical officer in the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The sites are being temporarily staffed by medical professionals from the National Disaster Medical System. Federal officials will turn over the sites to the hospitals at the end of January, if the centers are still needed, said Redd.
"These diverse sites provide models for each of these communities to show how infusion centers can work," he said.
Meanwhile, few hospitals or infusion centers around the US have decided to take on the challenge of administering the monoclonals. HHS is directing patients to its combatcovid.hhs.gov website to find out more about the therapies and to link to the new online locator for treatment sites.
Physicians and patients can also use the National Infusion Center Association's locator to find sites, said officials.
Effective, but Also Some Concerns
In Michigan, fewer than 2000 of 21,000 doses of monoclonals have been used, said William Fales, MD, medical director at the Michigan Department of Health and Human Services, during the briefing. Every hospital received doses but, in a surprise, most have been used by smaller, rural facilities, he said.
The health department's early analysis of 1500 patients shows that the treatment has been largely safe — with only 5% having any infusion-related issues — and effective, with about 5% going on to be hospitalized.
Wes Hoyt, MHA, chief of operations at the Hutchinson Regional Medical Center near Wichita, Kansas, told reporters that his center has administered monoclonals to 425 patients. "We've embraced their use as a key part of our treatment protocols," he said.
Patients are often referred by the large multispecialty medical practice across the street, which has a close relationship with the medical center. "Our patients are very happy to have an option," and motivated to avoid the hospital, said Scott Pauly, MD, a family medicine specialist at that practice, the Hutchinson Clinic. The therapies have also been well tolerated, he said.
But it was not all smooth sailing at Hutchinson. "The supply chain was not consistent in the beginning," said Hoyt, noting that he would only get 20 doses at a time and would sometimes have to wait 5 or 6 days for the next batch of 20.
And even though the government is paying for the cost of the drug, hospitals face many other costs. Reimbursement codes are not fully in place for administration, Hoyt said.
"We're in the hole over $100,000 for these infusions while we wait for codes to be entered into the governmental systems," he said. "I can absorb that for a little while, but if you're a smaller facility and you would like to do this, you can't afford to do so."
The Infectious Diseases Society of America (IDSA) meanwhile, recommends against routine ambulatory use of bamlanivimab and has issued similar caution for the Regeneron cocktail. Celine Gounder, MD, an infectious diseases specialist and member of President-elect Joe Biden's COVID-19 advisory board, said, "We do have concerns at the IDSA about what the impact could be in terms of putting genetic pressure for the virus to mutate to escape or evade the monoclonal antibodies."
Gounder spoke during a Johns Hopkins University webinar and said the Biden administration wanted to expand treatment emphasis beyond monoclonals.
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