Federal health agencies will depend on input from clinicians — including long-term care medical directors and physicians — during the rollout of Eli Lilly’s intravenous antibody therapy for high-risk COVID-19 patients, officials announced Tuesday.
The new drug bamlanivimab received emergency use authorization from the Food and Drug Administration on Monday. It is indicated for non-hospitalized adults and children aged 12 and older with mild to moderate COVID-19, and appears to work best early in the disease course to prevent severe outcomes.
The goal is to treat high-risk individuals shortly after diagnosis, Department of Health and Human Services officials said in a Tuesday press briefing. This includes adults over age 65 with comorbidities.
Phase 1 deliveries of bamlanivimab began this week to prioritized states and territories based on COVID-19 hospitalization numbers and overall cases. The states will allocate the drug to healthcare settings with infusion capabilities: hospitals and hospital-affiliated facilities.
Since infusion center patients should not mix with anyone diagnosed with infectious disease, HHS is now looking into alternative outpatient administration sites for phase 2 of its distribution plan. But the agency also must gauge the success of phase 1 implementation before it moves ahead, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, at the Tuesday briefing.
And that’s where clinician input will come in, said John Redd, M.D., MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS.
“Medical directors and physicians and other professionals who care for patients in long-term care facilities are a crucial part of our reachout as we expand the delivery of these new therapeutics,” he told the McKnight’s Clinical Daily in an email. “We intend to engage them with every phase of the rollout, and are looking forward to hearing from the hospital-associated long-term care facilities that are part of the initial distribution.”
Wait for nursing home trial data, clinicians say
While there seems to be general agreement that antibody treatment for COVID-19 looks promising, long-term care clinicians have advised a delay in delivering bamlanivimab to facility residents until more study data arrives. Eli Lilly currently is awaiting the results of a bamlanivimab trial set in nursing homes, for example.
“I am concerned about the impact that rushing this therapy would have on nursing homes and other long-term care settings, such as assisted living,” said Kevin W. O’Neil, M.D., chief medical officer of ALG Senior, a senior living provider based in Hickory, N.C. “I feel that we should await the results of such studies in order to determine if this treatment has benefits that outweigh the risks in the long-term care population,” he told the McKnight’s Clinical Daily on Tuesday.
Few long-term care providers have the resources to administer infusions and would require outside companies to provide that service, O’Neil explained. “At a time that COVID-19 cases are spiking nationally, that creates a risk for introducing the virus into the community.”
In addition, bamlanivimab infusions require monitoring not only during a one-hour infusion period, but for two hours afterward, O’Neil said. “That could put a great strain on the staffing.”
The role of antibody therapy
Monoclonal antibodies such as bamlanivimab are likely to be important weapons against the SARS-CoV-2 virus, added O’Neil. They attack the spike protein on the surface of the virus, preventing it from attaching and entering cells. However, they are likely to provide only short-term protection and are not seen as effective against severe disease, he said.
“Hopefully ongoing studies will demonstrate that they are effective for prophylaxis in high risk individuals, such as the elderly and those with multiple medical conditions, when exposed to the virus.”
Federal health officials meanwhile view therapeutics alongside vaccines “as two complementary parts of our plan to combat COVID-19,” said Dr. Redd of HHS. “This therapeutic is intended to treat patients with COVID-19 risk factors who are early in their disease, which includes the majority of residents of long-term care facilities.”