Monoclonal antibodies (mAbs) are still underutilized in long-term care but there are efforts underway to change this. For instance, in a recent letter published in the Journal of the American Medical Directors Association(JAMDA), a group of physicians observed, “MAb awareness, access, and administration remain significant challenges in post-acute and long-term care facilities.” They stressed, “In this rapidly evolving paradigm, it remains imperative to make mAb treatment available for appropriate PALTC residents when indicated.”
In August, the U.S. Food and Drug Administration (FDA) revised the emergency use authorization for the REGEN-COV mAb (casirivimab and imdevimab, administered together). The authorization allows REGEN-COV to be used as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 80 pounds) who are at high risk for progression to severe COVID-19, including hospitalization or death.
Prophylaxis is appropriate if the resident is at a higher risk for progression to severe COVID-19 due to key factors including older than 65 years, weight (obesity), and/or the presence of various diseases or conditions such as cardiovascular disease, chronic lung or kidney disease, or diabetes.
Additionally, mAb treatment of COVID-19 infection is considered well-suited for the long-term care population where:
- Resident has a documented positive viral test for COVID-19 (either rapid or PCR)
- Resident has mild to moderate COVID symptoms that started within the last 10 days
“Offering the treatment in place circumvents the need for transportation from the PALTC community to an outpatient infusion center and potential transmission of COVID-19 to all those in the path to the infusion center and back,” said the physicians in the JAMDA letter urging the appropriate use of mABs in long-term care. At the same time, FDA stresses that “prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19.”
While mAb use is encouraged, long-term care clinicians nationwide are having trouble accessing the product, due to a recent change in federal distribution policy. As demand for mAbs increased with the Delta variant, the Department of Health and Human Services issued restrictions that limit distribution to state health departments, in an effort to fairly allocate limited supplies. Long-term care industry advocates sent a letter to the White House’s policy adviser on October 20, detailing the problem and asking for a federally coordinated program to ensure mAbs access.
Read more here or, to read about efforts to manage mAb availability, click here.
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