The federal government will begin distributing Eli Lilly’s coronavirus antibody treatment this week, but supplies will be limited and getting the drug into infected patients will be a challenge, officials said.
The drug itself is administered through an IV infusion that takes more than an hour and requires another hour of observation afterward, officials said.
Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, told reporters during a conference call that they don’t want infectious COVID-19 patients mingling with cancer patients at traditional infusion centers.
Woodcock said the agency has been speaking with hospital systems, infusion providers and other stakeholders and anticipates that there will be challenges administering the drug.
“There are probably going to be multiple different solutions depending on the setting, [such as] community health centers, home IV, health infusion companies, nursing homes,” she said.
The Department of Health and Human Services (HHS) will distribute the drug to state health departments using the same system developed to allocate supplies of remdesivir.
Woodcock said the agency and Eli Lilly developed playbooks for local health systems to use to navigate the process.
“We’ll see how well the health care system is able to absorb this and how well they’ll be set up to deliver it,” Woodcock said.
HHS Secretary Alex Azar said distribution of the drug will be based on a states’ number of hospitalized COVID-19 patients and the number of overall cases.
The FDA issued an emergency authorization of the experimental drug on Monday for people newly infected with COVID-19 and who are seen as at risk of developing a severe form of the disease.
Officials on Tuesday emphasized the evidence shows it works only when administered early in the disease progression, and is not meant for hospitalized patients.
The U.S. already committed last month to 300,000 doses of the experimental drug, paying Eli Lilly $375 million.
The government has an option to buy an additional 650,000 doses next year, but Woodcock said she hopes the initial doses will “kick-start” the health care system into saving patients from being hospitalized with COVID-19.
Most patients will be able to receive the drug with no out-of-pocket costs. However, officials on Tuesday said people who have Medicare without supplemental insurance will have a $60 co-pay, which is 20 percent of the $300 infusion fee.