With agency report
The United States will this week begin distributing Eli Lilly and Co’s LLY.N COVID-19 antibody treatment to state health departments, Department of Health and Human Services (HHS) Secretary Alex Azar said on Tuesday.
Early treatment may help people avoid disease progression and avoid hospitalization,” Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said on a conference call along with Azar.
The FDA on Monday gave emergency use authorization to Lilly’s antibody for anyone over age 65 who is recently diagnosed with mild-to-moderate COVID-19, and for patients age 12 and older who have an underlying health condition putting them at risk for serious illness. The agency said the treatment should not be used in patients already hospitalized with COVID-19.
HHS will distribute the drug, bamlanivimab, using a system developed over the summer to allocate supplies of remdesivir, an antiviral drug developed by Gilead Sciences Inc GILD.O, which is approved for use in hospitalized COVID-19 patients.
Bamlanivimab allocations to states and territories will be based on their number of hospitalized COVID-19 patients and the number of overall cases, government officials said on the HHS call.
Woodcock explained that some states may have more people with underlying risk factors, such as obesity and diabetes. “Those are the people we are trying to target,” she said.
A one-time infusion of bamlanivimab has been shown to reduce the risk of hospitalization and emergency room visits.
The U.S. has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.
Drug distributer AmerisourceBergen Corp ABC.N will initially deliver the biotech drug to hospitals, but the aim is to widen distribution to outpatient infusion centers.
Officials said out-of-pocket costs for patients covered by the government Medicare program but without supplemental insurance would be $60. That represents a 20% co-payment for the $300 infusion fee.
Uninsured patients and those on Medicaid would have no financial responsibility, they said. Commercial insurance plans each have their own coverage terms.