As of Friday, the Biden Administration has secured a supply of a recently authorized COVID-19 therapeutic treatment, with the U.S. Department of Health and Human Services and the Department of Defense collaborating to purchase 100,000 courses of a second treatment from Eli Lilly and Company.
The treatment uses two monoclonal antibodies, bamlanivimab and etesevimab, to treat non-hospitalized, high-risk COVID-19 patients.
The U.S. Food and Drug Administration issued emergency use authorization for Eli Lilly's therapeutic of bamlanivimab and etesevimab on February 9. The treatment is administered through an intravenous infusion and is intended for nonhospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high risk for severe symptoms and hospitalization. The treatment uses a single dose for each patient.
The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Army Contracting Command to provide $210 million for the initial purchase of up to 100,000 treatment courses of the bamlanivimab and etesevimab therapeutic.
The agreement includes flexibility to purchase additional treatment courses as needed, up to a total of 1.2 million through November.
WHAT'S THE IMPACT?
Eli Lilly developed the bamlanivimab and etesevimab treatment without federal support. The two monoclonal antibodies that make up the combination therapeutic were identified from blood samples taken from patients who recovered from COVID-19.
Monoclonal antibodies, which mimic the human immune response, are produced outside of the body by a single clone of cells or a cell line with identical antibody molecules, and then delivered to patients by infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
This adds to the list of products available in the fight against the COVID-19 pandemic, including Lilly's single monoclonal antibody therapy, bamlanivimab, and Regeneron Pharmaceuticals' therapeutic that uses casirivimab and imdevimab. Both received emergency use authorization in November 2020.
To help states and territories identify and allocate the treatment courses to nonhospital facilities that serve priority and underserved populations, HHS initiated the Special Projects for Equitable and Efficient Distribution (SPEED) program.
Eligible facilities include nursing homes, assisted living facilities, federally qualified health centers, correctional facilities and dialysis centers, as well as other settings.
HHS also implemented a direct-ordering system for healthcare facilities to order any of the available therapeutics, and all three remain free of charge to receiving sites.
To help patients and healthcare providers find possible treatment locations for any of the available antibody therapeutic treatments, HHS created a treatment locator that provides information on where the medicines have been delivered.
In issuing EUAs for the monoclonal antibody therapeutics, the FDA noted the potential for adverse events or side effects of bamlanivimab alone, or when administered with etesevimab and in administering Regeneron's casirivimab and imdevimab.
THE LARGER TREND
Then-Health and Human Services Secretary Alex Azar said in December that doctors have not been prescribing COVID-19 treatments as often as they should, and said patients over 65 or with comorbidities should ask their doctor about whether they can be put on the drugs. Azar said they can prevent hospitalization and severe consequences, and in some cases can shorten hospital stays.
That's exactly what HIMSS TV contributor, entrepreneur and patient advocate Kate Milliken did recently upon contracting the coronavirus. Milliken, who lives with multiple sclerosis, told HIMSS TV this month that she had to convince her primary care physician to recommend monoclonal antibody treatments.
"Twenty-four hours later my fever dissipated and I felt remarkably better," she said.