UnitedHealth Group and Eli Lilly are teaming up to further study the effects of the drugmaker's antibody therapy in high-risk COVID-19 patients.
The drug, bamlanivimab, which is administered via infusion received emergency use authorization from the Food and Drug Administration (FDA) in November to treat patients with mild or moderate COVID-19 symptoms who are at high-risk for severe symptoms or hospitalization.
UnitedHealth will enroll 500,000 Medicare Advantage members who are diagnosed with COVID in the study, and follow them through their treatment via daily symptom tracking and in-home testing. For those who need bamlanivimab, the drug will be administered via home infusion.
Ken Ehlert, chief scientific officer, UnitedHealth Group and chief executive officer, OptumLabs, told reporters on a call that the companies do not expect all of the patients included in the study to need bamlanivimab, and estimated about 5,000 doses or so are expected to be needed.
Patients who volunteer for the study will be directed to download Optum's ProtectWell app and complete questionnaires each day. Those with symptoms will take an in-home test for COVID-19, and those who are positive will be contacted by an Optum infusion nurse to schedule a treatment.
For the study, patients will receive the therapy with no copay for the drug or infusion services, Ehlert said on the call.
“Intercepting the disease before it escalates may help to keep people out of the hospital and reduce the overwhelming burden on the healthcare system," Ehlert said in a statement. "By bringing together UnitedHealth Group’s expertise in science, clinical research, and technology, with Lilly’s expertise in pharmaceutical development, we can responsibly and safely accelerate research on this new potential COVID-19 treatment.”
Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said on the media call that UnitedHealth Group's size and diversity make it an optimal partner for research on this scale.
Skovronsky said that while Lilly conducted enough research into the drug's efficacy to secure the emergency use, the ongoing study allows for a greater body of data on how it works and allows the company to examine its impact on specific populations, such as people of color.
The doses included in the study are not a part of the 950,000 purchased by the federal government to date for distribution. The Trump administration announced this week that it had purchased an additional 650,000 doses of the therapy.
The Department of Health and Human Services (HHS) also enlisted CVS Health for a separate pilot to administer the drug through home infusion.