HHS and DoD Buy 100K Eli Lilly Combo Monoclonal Antibody Treatments, with Option to Buy 1.1 Million More

The Biden administration has secured 100,000 doses of Eli Lilly’s combination monoclonal antibody (mAB) treatment to be delivered through March 31, with an option to buy an additional 1.1 million doses through November of this year. But will hospitals and outpatient centers even use them?

So far, they’re not.

Currently, less than 30 percent of available monoclonal antibody doses allocated nationally are infused into arms, according to Vizient, a group purchasing organization that negotiates contracts for medicines on behalf of about 3,000 hospitals and healthcare facilities in the U.S. As a result, an excess of both the Lilly and Regeneron monoclonal antibody products sit unused.

Steve Rudner, director of pharmacy network contracting for Vizient, said there are two primary barriers to increasing use of monoclonal antibodies, which are the only therapy authorized by the FDA so far that ’s aimed at preventing patients from being hospitalized in the first place. The first barrier is operational.

“These products are complicated to compound and must be infused to the patient within 10 days of the onset of symptoms,” he said. “Providers are challenged to identify patients within this time frame and then identify an appropriate clinical setting for them to receive treatment without spreading the virus.”

The second barrier, he said, is provider awareness and supporting clinical data.

“Some providers are not fully aware of the benefits of mABs and those that are have said they are unsure there are enough clinical data to support the effort to overcome the operational challenges,” said Rudner.

It takes about an hour to complete infusion of a monoclonal antibody treatment, and the patient must stay on for an hour of observation. The patient must also be isolated so others aren’t exposed to COVID-19. Logistically, it’s challenging for hospitals that are already busy and crowded with patients experiencing acute complications of COVID-19, said Pieter Cohen, an associate professor at Harvard Medical School and a physician with the Cambridge Health Alliance Respiratory Clinic.

“Monoclonal antibodies require significant healthcare resources to deliver,” he said, “and during the pandemic we often have to make difficult decisions, such as should we be using available resources to get COVID vaccines into our patients or bring infectious patients into healthcare centers to receive novel treatments?”

Regardless, forward motion on the treatment option continues.

HHS and the Department of Defense (DOD) are jointly providing $210 million for the purchase of Eli Lilly’s combination treatment using bamlanivimab (700 mg) and etesevimab (1,400 mg) together, the company said.

The combination of the two antibodies received Emergency Use Authorization (EUA) in early February for the treatment of recently diagnosed, mild-to-moderate COVID-19 in patients who are at high risk of clinical progression.

Also, the National Institutes of Health (NIH) recently updated its COVID-19 treatment guidelines to recommend Eli Lilly’s combination monoclonal antibodies for the treatment of outpatients with mild-to-moderate COVID-19 who are at high risk of the disease progressing.

The U.S. government had already committed to buying a total of 1.45 million doses of Eli Lilly’s bamlanivimab alone, which includes more than 1 million doses that have already been delivered and an agreement to deliver 450,000 additional doses by March 31. Bamlanivimab got an EUA from the FDA in November of last year.

The U.S. government has said it will provide the antibodies at no cost to patients, but hospitals and outpatient could charge fees for administering it.

In other monoclonal antibody-related news, Regeneron’s COVID-19 treatment was recommended by the European Medicines Agency’s Human Medicines Committee (CHMP) for approval prior to a conditional marketing authorization for the treatment of COVID-19 patients who don’t require supplemental oxygen and who are at high risk of progressing to severe disease. Regeneron’s combination therapy, REGN-COV2, includes casirivimab and imdevimab.

In parallel, a rolling review by EMA of the combination of antibodies casirivimab and imdevimab, which started on Feb. 1, is ongoing. Once finalized, it will be the basis for an EU conditional marketing authorization for that combination therapy. — Suz Redfearn