Update on Monoclonal Antibody Therapies

Posted on December 23, 2020 by Kari Everson

LeadingAge Minnesota received information this week from the Minnesota Department of Health (MDH) about the status of implementation of monoclonal antibody therapies for COVID-19, and we wanted to share the lates with members.

Background

Monoclonal antibodies are laboratory-made proteins that mimic the immune system and are able to fight things such as viruses.  Monoclonal antibody therapy is a COVID-19 treatment administered through intravenous infusion that, if administered in the early stages of illness, appears to prevent the progression of COVID-19, decrease the length of illness, and may prevent hospitalizations.  Two treatments are now available through FDA Emergency Use Authorizations: Eli Lilly’s Bamlanivimab and Regeneron’s Casirivimab and Imdevimab.  Our focus is on Bamlanivimab (BAM), because it is the treatment currently approved for distribution to non-hospital locations such as long-term care facilities. 

BAM is a monoclonal antibody specifically directed against one of the proteins on the spike of the SARS-CoV-2 virus.  It is designed to stop the virus from attaching onto and entering into human cells.

MDH has established a Therapeutic Options for COVID-19 Patients webpage that complies information on these treatments, including a clinical screening tool to identify eligible individuals for facilities administering the treatment, fact sheets for patients and providers, FAQs, and a Monoclonal Antibody playbook.

Treatment with BAM is most appropriate for individuals with mild to moderate disease early in their infectious stages and who are at high risk for progressing to severe COVID-19 and/or hospitalization.  It is best to treat as soon as possible after confirmed positive test and within 10 days of symptom onset.

Current Status of Implementation

The U.S. government has secured supplies of these therapies and is distributing them to states.  As Minnesota receives shipments, it distributes those doses through our eight Regional Health Care Coalitions to locations where they can be administered.  Here is where things stand currently:

• Minnesota has received 11,000 doses to date, most of which are Eli Lilly’s BAM treatment.
• 90 Minnesota sites have received shipments, and 42 of those are up and running.  1,244 infusions have been completed so far.  MDH expects the number of infusions to grow as more sites become available and as providers and patients become more aware of the treatment’s availability. 
• Initially supplies went only to hospitals, but a small number of skilled nursing facilities have recently received doses for use with residents, including several that are co-located with a hospital. SNFs are receiving only the Bamlanivimab treatment. 
• At this stage MDH is not distributing these therapies to assisted living settings, but that possibility will be considered in the weeks ahead.

Long-term care communities interested in providing Bamlanivimab therapy in their organizations, including both nursing homes and assisted living settings should complete a redcap survey.  Administration of this infusion is clinically complex, and the questionnaire is designed not only to gauge interest but also whether an organization meets a variety of requirements necessary for it to be done safely.  Prior to filling out the REDCAP survey, you should review the Monoclonal Antibody Therapy Playbook and Therapeutic Option for COVID-19 Patients particularly to review a few key aspects of administration.  These include but are not limited to:

• Ensure you have a dedicated space and develop a plan to manage patient flow
• Ensure you have access to a source of supplies including infusion kits, VS monitoring equipment and emergency medications such as epinephrine.
• Have an emergency protocol for allergic/anaphylactic reactions
• Determine if you have sufficient staff to administer therapy
• Prepare for reporting needs for adverse events

For organizations that would like to provide BAM, complete this REDCAP survey.  Once you’ve completed the REDCAP survey, someone from MDH or the Regional Healthcare Coalitions will contact you for further discussion.

On a separate track, the U.S. Department of Health & Human Services has launched a new pilot program for the allocation of monoclonal antibodies called the Special Projects for Equitable and Efficient Distribution (SPEED).

The goal of SPEED is to assist states in identifying non-hospital/non-hospital affiliated facilities that serve priority populations, including long-term care, and allocating monoclonal antibodies for administration.  SPEED is separate yet complementary to the state-based allocation system described above.  Current SPEED programs include home infusion providers dispensing and providing nursing support for administration of monoclonal antibodies in nursing homes and assisted living facilities, and direct allocations to long-term care pharmacies for deployment when cases occur in nursing homes and assisted living communities served by each pharmacy. We will gather additional information about this program and share details with members as soon as possible.

We have shared with MDH leaders that we are very interested in working with them on how to increase long-term care involvement in safely delivering this promising therapy to older Minnesotans, across all of these various treatment distribution tracks.

For questions, please contact Kari Everson at keverson@leadingagemn.org or 651-380-2032.