Update on Monoclonal Antibody Therapy Authorized for Emergency Use
On Nov. 9, the Food and Drug Administration granted emergency use authorization (EUA) to a monoclonal antibody therapy called bamlanivimab, produced by Eli Lilly and Company, for the treatment of mild to moderate COVID-19. The federal government has purchased 320,000 doses through the end of 2020; the first allocation to California will be 4,040 doses. California is expected to receive allocations each week.
AmeriSource Bergen, which distributes remdesivir, will begin distributing bamlanivimab to hospitals as early as today (Thursday) or tomorrow (Friday).
Many hospital leaders have questions about the drug and what they and their patients can expect. CHA has been in regular communication with the California Department of Public Health (CDPH). Here’s what we know so far:
How is it being allocated within California?
For the first phase, the state can direct the doses only to hospitals and their affiliated locations. A second phase is anticipated to allocate the doses to a broader range of settings.
How many doses should hospitals expect to receive?
CDPH will allocate doses among the counties. County Medical Health Operational Area Coordinators will determine how much hospitals in their county will receive. AmeriSource Bergen will then distribute the doses directly to hospitals
What should hospitals to do prepare?
Hospitals should review the EUA fact sheet for health care providers and determine how they might best be able to provide access with the least disruption to other services.
Where can the drug be administered?
This one-hour infusion with at least a one-hour observation for adverse events can occur in a number of settings. In its final outpatient administration playbook for monoclonal antibodies issued by Operation Warp Speed, the federal government notes that, as part of the Centers for Medicare & Medicaid Services Hospital Without Walls initiative, hospitals can provide services outside of standard hospital settings, as long as the alternate site of care is linked to the hospital to allow for reimbursement of medical services.
Who should receive it?
This is for outpatients with mild-to-moderate symptoms of COVID-19. In the clinical trials, the groups that benefited were people 65 and older and people with a body mass index of 35 or more. CDPH is interested in providing access to this medication to people in skilled-nursing facilities and is interested in any ideas hospitals have to help provide this access.
To learn more about the federal government’s allocation plans and EUA, see CHA’s Coronavirus Response article from Nov. 10.