Tennessee officials are trying to raise awareness about monoclonal antibodies, a potentially life-saving treatment designed to keep high-risk COVID-19 patients with mild to moderate illness out of the hospital.
In November, the U.S. Food and Drug Administration authorized the use of two different monoclonal antibody treatments, bamlanivimab and casirivimab/imdevimab. The latter, developed by the biotech company Regeneron, rose to fame when President Trump received - and praised - the experimental drug after he was diagnosed with COVID-19 in early October.
The drugs work by mimicking the antibodies that target the coronavirus, preventing it from spreading throughout the body, but must be given early in the disease process and aren't for use in hospitalized patients.
During a news briefing last week, Gov. Bill Lee touted the drugs and urged Tennesseans age 65 and over and those with multiple chronic conditions to ask their medical provider about monoclonal antibodies upon receipt of a positive COVID-19 test.
"So many folks don't contact their health care provider in order to ask about monoclonal antibodies," Lee said. "They're very effective, particularly in this period of time before we get our elderly population vaccinated."
Tennessee Health Commissioner Dr. Lisa Piercey echoed Lee's remarks, calling the drugs effective at preventing progression to severe disease.
"Not only does this help individual patient outcomes, this helps hospital demand, as well," Piercey said. "We have not used our entire inventory - nowhere close to that - and so we really are trying to get the word out to seek treatment early."
The treatment itself is not commercially available and is distributed to states by the federal government free of charge.
USA Today reported Thursday that the same issue is playing out across the nation after a briefing where Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, said the federal government has shipped more than half a million doses to more than 3,700 locations across the country.
The U.S. Department of Health and Human Services has already agreed to purchase more doses and has the option of buying millions more, according to USA Today.
"And yet, we're not seeing full utilization," said Woodcock, saying a lack of public awareness is partially to blame for the limited use.
However, some leading scientific agencies, including the National Institutes of Health, say there's limited evidence that the therapy is effective, which is likely causing hesitancy among some providers to refer their patients for treatment.
"In patients at increased risk bamlanivimab is a reasonable treatment option if, after informed decision-making, the patient puts a high value on the uncertain benefits and a low value on uncertain adverse events," according to treatment guidelines from the Infectious Diseases Society of America.
Dr. Todd Rice, an associate professor of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, agreed that more public awareness around monoclonal antibodies is needed, but there are many other hurdles that prevent easy access to the drug.
"It's an IV infusion, so it's not like I can call it a prescription at CVS thinking you can go pick up a pill and take it," Rice said, adding that officials probably underestimate the logistical issues that presents.
Dr. Jay Sizemore, an infectious disease specialist at Erlanger Health System, said via email that because the treatment is given through IV infusion, the hospital had to develop special protocols to safely administer the drug.
"The hospital decided it wouldn't be a good idea to take COVID-19 positive patients into an infusion center where you have immunocompromised patients there for chemotherapy, etc.," Sizemore said, adding that Erlanger decided that the emergency department was the best place to administer the drug.
For these reasons, the treatment isn't widely available, and patients often have to go through the effort of finding a place that offers it themselves.
If you test positive for COVID-19 and meet the following criteria, you may be eligible to receive a monoclonal antibodies infusion:
- Your COVID-19 test comes back positive- You are not hospitalized- You are less than 10 days since onset of mild to moderate symptoms- You have high-risk factors that include: >65 years old, obesity with body mass index >35 (adults), diabetes, chronic kidney disease, immunosuppressive disease, or on immunosuppressive therapy- >55 years old AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease / other chronic respiratory diseaseSource: Tennessee Department of Health
In Hamilton County, the treatment is available at Erlanger, CHI Memorial Hospital and Chattanooga Kidney Center on Highway 58.
Across Southeast Tennessee, Athens Regional Medical Center, Rhea Medical Center and Southern Tennessee Regional Health System in Winchester offer the drug, according to a list on the Tennessee Department of Health website.
Although the drug itself is free, there's still a cost of administering it, meaning cost could be a barrier to some patients depending on their insurance status.
Spokespeople from both Cigna and BlueCross BlueShield of Tennessee said the insurance companies cover all aspects of the treatments, but people without health insurance or with policies through different insurers could still wind up paying out of pocket for the drug to be administered.
In addition to the logistical challenges and potential cost barriers, Rice said patients must sit for the hour it takes to administer the infusion and then wait another hour after to make sure they don't experience an allergic reaction.
"That's what's made this hard and it's made it so that we're not using as much of this as we have available," he said.
Despite the challenges, he thinks it's worth the effort.
"I think a lot of people don't even know that it's out there available and that they might be helped by it," Rice said.
Bill Christian, a spokesperson for the Tennessee Department of Health, said in an emailed statement that Tennessee had provided more than 5,000 monoclonal antibody treatments as of last week. Christian did not respond to multiple inquiries as to how many treatments the state now has on hand.
Contact Elizabeth Fite at efite@timesfreepress.com or follow her on Twitter @ecfite.