Monoclonal antibody therapies for COVID-19 from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. are not being used in the amounts anticipated because the medicines are too complicated to administer and must be given at the right time to be effective, a top adviser to the White House said.
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Only as much as 20% of the medicines that have been purchased by the federal government and allocated to U.S. states and territories and some federal agencies, such as the U.S. Department of Veteran's Affairs, are being used, according to Moncef Slaoui, chief scientific adviser for the White House's Operation Warp Speed public-private partnership.
Both the Lilly and Regeneron COVID-19 antibody drugs have received emergency use authorization from the U.S. Food and Drug Administration.
In a Dec. 15 interview with CNBC, Slaoui cited complications with administering the antibody therapies as the reason hospitals and outpatient facilities are not using the medicines.
The drugs, which are infused intravenously, are intended to treat mild to moderate symptoms of COVID-19 in non-hospitalized adults and adolescents as young as age 12 who are at high risk of progressing to severe disease or hospitalization.
The infusion of the medicines takes about one hour and must be followed by an observation of at least another hour.
Facilities that provide the antibody drugs must have a dedicated patient area or isolation rooms available to administer the therapies and provide follow-up patient care in a manner that minimizes infection transmission, the U.S. Department of Health and Human Services stated on its website.
An HHS spokesperson told S&P Global Market Intelligence that Slaoui had accurately portrayed the current utilization data reported to the agency for the Regeneron and Lilly drugs.
"It's important to keep in mind that this week was the first time HHS had requested utilization information from facilities and providers administering the drugs," the spokesperson said. "We will continue working with stakeholders to learn more about their utilization decision."
HHS Sec. Alex Azar also confirmed Slaoui's report during a Dec. 15 appearance on CNBC's "The News with Shepard Smith," saying people are waiting too long to seek treatment and are missing the criteria window for when the medicines are supposed to be used.
The federal government paid Lilly $375 million for 300,000 doses of its COVID-19 antibody drug bamlanivimab in a deal that may be worth over $1 billion for the Indianapolis-based drugmaker if an option to buy up to 650,000 additional doses is triggered.
The government also signed a $450 million contract to obtain at least 300,000 doses of Regeneron's antibody cocktail, casirivimab and imdevimab, also known as REGN-COV2.
The drugs received a lot of attention because of some of the high-profile people who have been treated with them.
President Donald Trump was treated with Regeneron's antibody cocktail, as was his personal lawyer Rudy Giuliani and Ben Carson, the secretary of Housing and Urban Development. Trump's ally Chris Christie, the former Republican governor of New Jersey, was treated with Lilly's drug. The VIP access of the limited drugs by Trump and his associates raised eyebrows with the bioethicist community.
As of Dec. 9, HHS had allocated a total of 337,182 treatment courses of the two drugs to states and territories and the designated federal agencies — 259,920 of Lilly's medicine and 77,262 of Regeneron's therapy.
Lack of resources
There is limited information known about the safety and effectiveness of the drugs in treating COVID-19, the FDA acknowledged.
But based on the data, it was "reasonable to believe" the known and potential benefits of the antibody medicines outweigh their known and potential risks, the agency said.
Erin Fox, senior pharmacy director at University of Utah Health, noted that treatment guidelines from the U.S. National Institutes of Health do not recommend for or against the use of the antibody drugs.
"The data for these products isn't that amazing," Fox told S&P Global Market Intelligence.
But the main difficulty with administering the antibody therapies is a lack of resources, she said.
"Standing up a temporary infusion site isn't that difficult but it is when you don't have enough nurses and you have to work hard to find patients," Fox said. "For example, here at our health system, nurses are being trained to be extenders in our hospital as we face the surge from the holidays."
The other problem Fox said is that patients must be treated with the medicines early.
"For patients that take a COVID test, they may not get results back and [be] in touch with a medical provider who could recommend this treatment," she said. "Test results aren't always communicated back to a patient's primary care provider and many patients don't have one. It's not like we have a national system — it's piecemeal."
Utah has a publicly available website that includes information about the antibody treatments but patients must be proactive and know about it, Fox said.
"Our health systems are working on ways to proactively identify patients who test positive and would benefit most," she said. "You can get a computerized list, but you still have to call the people, see if they want the treatment, get them scheduled, etc. That again takes time and people."
Fox said her health system has been ramping up its ability to provide the antibody infusions and are hoping that by early next week it will be able to do more proactive calls to patients.
"We have also made sure that rural hospitals with space and room in their emergency rooms have product on hand," she said.
Onus on hospitals
But the federal government has put the onus and work on hospitals to "figure out this outpatient drug when hospitals are already stretched very thin," Fox said.
HHS determines the allocation of the medicines based on information it receives from hospitals and states and territories, including the number of confirmed COVID-19 cases in the jurisdiction and the number of hospitalized patients confirmed with the disease.
Those data are collected weekly through HHS Protect tracking system and compared proportionally by the total number of cases in the country for that week, the agency said.
Reporting to HHS about the number of doses that have been administered or are on hand is currently optional but will become mandatory on Jan. 8, 2021, Fox said.
The other complication is that states and hospitals are now focused on preparing to receive and administer the COVID-19 vaccines, "which takes resources," Fox said.
"We are really trying our best," she said.
Addressing the challenges
A Lilly spokesperson told S&P Global Market Intelligence that the company was aware of the HHS data.
"The intravenous administration of therapeutics to patients with confirmed mild to moderate COVID-19 presents unique challenges to the healthcare system," Lilly's Dani Barnhizer said in an email response. "Lilly is partnering with stakeholders to address challenges and ensure patients who need bamlanivimab can get it."
Lilly expects to have a total of 950,000 doses of the drug available by end of January 2021.
Barnhizer noted there are multiple pilot programs underway through the Warp Speed project, including a pilot with CVS Health Corp. for in-home infusions and state product trackers.
"Numerous infusion center setups are emerging around the country, such as new dedicated centers, 'off hours' at existing facilities and large scale public repurposed space," Barnhizer said.
Regeneron spokesperson Hannah Kwagh said the company is partnering with state and federal government authorities to expedite solutions and has provided detailed educational resources on its website.