Long-term care clinicians have asked the federal government to delay allocating monoclonal antibody therapy to nursing homes until further study — and to collaborate with facility medical directors when they do.
Antibodies help the body mount an immune response to thwart severe disease. Two drug candidates have shown promise in treating COVID-19. Their makers, Regeneron and Eli Lilly, have applied for federal emergency use authorization to allow the drugs to be given to certain high-risk patients while late-stage trials are ongoing.
With approval predicted in the coming weeks, the question of who should receive this treatment and how it will be provided is an open question, said AMDA-The Society for Post-Acute and Long-Term Care Medicine.
In a Friday letter to Health and Human Services Secretary Alex Azar, the organization argued that these therapies require more testing to ensure safety and effectiveness in frail, elderly populations. In addition, the drugs are meant to be given intravenously within days of a positive test result. Nursing homes currently are not prepared to administer infusion therapy, AMDA said.
“This is the right therapy, but it needs more study for us to understand its effects in the nursing home population, and it needs engaged medical director oversight and supervision,” AMDA’s Executive Director Chris Laxton told the McKnight’s Clinical Daily.
Furthermore, using these medications widely in the nursing home setting would remove potential subjects from needed clinical studies, AMDA’s letter stated. “Without these trials we cannot be sure what the potential risks or harms to our patients might be,” the organization said.
Questions at the state level
AMDA has asked that HHS offer national guidance on how the therapy will be prioritized, administered and paid for. And its concerns are being echoed on the state level.
The National Governors Association last week published a “need to know” document about the drugs, prompting state health officials to help develop guidance for “efficiently targeting limited resources to populations who are most likely to benefit, and address potential barriers to access for populations at highest risk of serious outcomes from COVID-19.”
NGA also recommended that state officials assess the capacity for delivering monoclonal antibodies to COVID-positive patients in various healthcare settings, including nursing homes.