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PW special report: A treatment for COVID-19…and a giant information gap 

Many North Carolinians who could benefit from a COVID-19 therapy lack information and access

Treatment with special proteins called monoclonal antibodies is keeping some COVID-19 patients out of hospitals and is likely saving some lives. But North Carolina has huge information and delivery gaps to fill before many people who might qualify for the therapy know about it and can get it.

Monoclonal antibodies are made in labs. They work like proteins the body makes, attaching to virus particles to keep them from infecting cells. The FDA in late November gave emergency use authorization [1] to a mix of antibodies made by Regeneron Pharmaceuticals. That’s the therapy former President Donald Trump received when he fell ill with COVID-19 last year.

Duke Health [2] publicized the therapy offered at one of its clinics back in April.

Federal officials began discussing the therapy at White House briefings as early as January. At a White House press briefing last week [3], Dr. Anthony Fauci called monoclonal antibodies “a much-underutilized intervention for COVID-19.”

[4]

(This map shows locations that have received shipments of monoclonal antibody therapeutics. Source: U.S. Department of Health and Human Services) 

The FDA said the therapy can be used for people 12 and older who have mild-to-moderate symptoms and are at risk of serious illness, hospitalization, or death from COVID-19. A study that has not yet been peer-reviewed [5] found that the therapy reduced hospitalization and death by about 70% when given within 10 days of initial symptoms.

A few weeks ago, the FDA revised the rules, saying Regeneron can also be used by people 12 and older who are exposed to the virus, are not fully vaccinated, and are at risk of severe illness.

Gaps in service to rural residents, communities of color, non-English speakers, and people without doctors

Hospitals, clinics, pharmacies, and infusion centers around the state offer monoclonal antibodies [6]. But a map of available locations shows gaps in rural areas.

For example, someone living in Roxboro, about an hour north of Raleigh, would have to travel about 40 miles round trip to get to the closest locations offering the therapy. The trip would be even longer for someone living in the Moore County town of Carthage.

None of the state’s federally qualified health centers, which provide health care to underserved areas statewide, offer the therapy yet.  That means that patients in Durham, for example, can go to Duke locations for the therapy, but not to Lincoln Community Health Center, located in a historic Black community in the city.

Few locations offering the therapy are in the heart of Black communities.

[7]

(Antibody treatment centers near Raleigh, Source: U.S. Department of Health & Human Services, 2020 Census redistricting file via ESRI Living Atlas) 

On its website, the state Department of Health and Human Services advises people to call their health care providers to see if they qualify for the treatment. But many people in the state, some with jobs that put them at higher risk of becoming infected, don’t have primary care doctors.

DHHS is considering ways to get the information to people who may not have doctors, speak English as their first language, or spend much time online.

Information about the therapy had not made it out to a vaccination clinic in Tarboro last week, set up outside El Manantial tienda y taqueria. The store is a popular spot on Fridays because workers go there to cash their checks. The event started in late afternoon, a time convenient for people to stop by after work.

The Association of Mexicans in North Carolina, or AMEXCAN, organized the event where people could get a shot, pick up packaged food, hand sanitizer and masks, long-sleeved shirts, and health information. Dr. Karyn Hargett, director of the Old North State Medical Society’s COVID-19 Health Equity Project, administered the injections.

AMEXCAN has a state grant to work in 11 counties to increase vaccine access. It had no information about monoclonal antibody therapy, however.

One of the AMEXCAN workers at the site said she’d never heard of the therapy. “We mostly try to just get the community to be vaccinated, especially with the Delta variant going around,” said Marlene Castillo, director of disaster relief at AMEXCAN. “We’re trying to raise awareness, especially in rural areas.”

  

[8]

(Antibody treatment centers in Durham, Source: U.S. Department of Health & Human Services, 2020 Census redistricting file via ESRI Living Atlas) 

State officials look to expand efforts

Amanda Fuller Moore, a pharmacist in the NC Division of Public Health, said in an interview Monday that the state is planning to add six community-based sites that patients can use without going through a medical provider. The agency is not, however, ready to announce the locations, she said. The federal government will help staff those sites.

The antibodies themselves are free, though providers may charge for administration. Medicare is picking up those charges for its patients. Fuller Moore said Medicaid and most private insurers are also covering the administration charge, and providers can be reimbursed for treating people without insurance.

The therapy is taken by IV or as a shot. Patients must be monitored for an hour afterward.

The state doesn’t direct distribution of monoclonal antibodies as it did COVID-19 vaccines when they were first available. Providers order the shipments on their own.

But the state Department of Health and Human Services plays a central role in disseminating public health information. State health officials have been discussing the treatment a lot more in the last month. Even so, Fuller Moore said the state has focused on making sure people know the importance of COVID-19 vaccines. The antibody therapy is not a substitute for vaccines, she said.

“Vaccination is our best option,” she said. “We really wanted to be clear about that early on.”

[9]

(Antibody therapeutic centers near Winston-Salem are located in neighborhoods with low shares of Black residents. Source: U.S. Department of Health & Human Services, 2020 Census redistricting file via ESRI Living Atlas) 

COVID-19 cases are surging again, and some people who are vaccinated are testing positive.

The health agency is continuing to encourage vaccinations and is also telling people who have tested positive “that monoclonal antibody treatment could be an option,” Fuller Moore said.

The state has asked labs when they notify people who test positive for the virus to include information about monoclonal antibody therapy and where it is available. DHHS plans to more prominently place a mention of the therapy on its website. The department is using social media to spread the word, and this month it published fliers about monoclonal antibody therapy in English and Spanish.

The state is also paying for 600 community health workers who provide health education and connections to medical care and other essentials to people in underserved communities. Community health workers started going into neighborhoods with information and aid last year. The program is expected to last until June 30, 2022.

Community workers on a LATIN-19 Zoom call Wednesday talked about challenges of gathering large quantities of information about COVID-19 vaccinations, booster shots, and testing locations for children who may have been exposed to the virus at school.

LATIN-19 [10] is a network of doctors, community workers, health officials and others working to provide COVID-19 information and resources to Latino communities.

North Carolina has drawn national praise [11] for its tracking of vaccination demographic data and using it to reduce racial inequities. The state has asked providers for racial data on patients receiving monoclonal antibody treatments. Fuller Moore said the agency has not yet decided whether it will be made public. The collection just started, and the quality of the data is unknown. In the first week of the survey, when providing the information was optional, most providers selected “missing.”

Jason Williams, founder and director of W.A.R.4Life [12], or We Are Ready For Life, a Durham-based nonprofit that drove mobile vaccination vans to underserved communities, said he has received no official information on monoclonal antibodies, though he does know people who have had the therapy.

“We haven’t gotten any guidance from the state or anyone else,” he said.

Chris Shank, president and CEO of the North Carolina Community Health Care Association [13], which represents the state’s federally qualified health centers, said the group received information about offering monoclonal antibodies last week. They had a meeting recently to see if any of the centers want to offer the therapy, and several are interested, she said. A complication is the lag in Medicare payments for infusions, Shank said in a text message. Medicare does not reimburse health centers for monoclonal antibody infusions until the end of the fiscal year.

On Monday, DHHS told agencies that do COVID-19 testing to start spreading the word about monoclonal antibody therapy, said Jenie Abbotts, a quality improvement nurse at the association.

“I’m excited to see it get out there and start to be administered more broadly,” she said. “I’m excited to have that as something to use to try to reduce hospitalization for people.”