Monoclonal antibodies have emerged as a powerful tool for reducing hospitalization and death from COVID-19, but recently published studies suggests that the lab-created proteins are going to those who need them less — patients with the fewest chronic conditions — while usage in hospital outpatient clinics has followed a persistent pattern of racial and ethnic disparities.
Researchers analyzing more than 2 million Medicare claims for monoclonal antibodies found that individuals with no chronic illness were five times more likely to receive monoclonal antibody treatment than those with six or more chronic conditions, who represent more than 1 in 3 Medicare enrollees.
“By far, the largest disparity was that the healthiest people got monoclonal antibodies,” said Michael Barnett, a physician and health policy professor with Harvard T.H. Chan School of Public Health in Boston. “Basically, those that most need it were actually the least likely to get it. It’s not surprising that this played across racial lines as well.”
But there has been pushback by conservatives in states that have adopted the Food and Drug Administration’s guidance of considering race and ethnicity as factors — though not the only or most important ones — when deciding who to prioritize for treatment.
Like most states, Florida does not target distribution of monoclonal antibodies by race, ethnicity or poverty, though those factors can greatly affect an individual’s access to care — and the likelihood that they will survive a bout with COVID-19. According to the Centers for Disease Control and Prevention, the risk of infection, hospitalization and death is higher for people of color compared with white, non-Hispanic persons.
Those most in need are least likely to get them
If states want to address such persistent inequities in health, which have been exacerbated by the pandemic, then public health officials must confront racial and ethnic disparities head on, said Barnett, who co-authored a Feb. 4 research letter published in the Journal of the American Medical Association based on an analysis of nearly 2 million Medicare claims for monoclonal antibody treatments from November 2020 to August 2021.
“Expecting something different without doing anything different is foolish,” said Barnett.
A separate report published by the CDC on Jan. 14 found racial and ethnic disparities in the use of COVID-19 treatments at hospital outpatient clinics between March 2020 and August 2021.
Sonja Rasmussen, a pediatrician and epidemiologist at the University of Florida College of Medicine, co-authored the CDC report and said one of the biggest barriers for patients to receive monoclonal antibodies is awareness — recognizing symptoms early and then knowing when and where to seek treatment.
And even then, there can be barriers. Monoclonal antibody treatments are free for patients, regardless of where they receive them, but not everyone knows that.
“You might hear about these medications but then think, ‘I don’t have health insurance and I’m really worried that if I go there, they’re going to ask me for money’,” she said.
On Friday, Florida’s health department updated its online database of treatment providers to make it easier for residents to find therapies nearby, though most patients will still need to consult a healthcare provider to get the drugs.
Rasmussen acknowledged that “it’s hard to tell the reasons why” the CDC report found racial and ethnic disparities in COVID-19 treatments, which also include antivirals and steroids, at hospital outpatient clinics. The data could not be adjusted for age or clinical factors that might be correlated with race and ethnicity.
But persistent disparities in health and health insurance coverage among people of color and low-income individuals predate the pandemic, and public health officials must make an effort to reach those populations they know are more likely to be at risk of severe illness from COVID-19, Rasmussen said.
“How do we figure out the barrier?” she said. “If I’m Black and poor, what’s my barrier to that access? Because if I have diabetes — and we know those risk factors are higher in minority populations — it’s even more important to have medications available. What is the state doing? Are infusion sites in poor communities?
“There needs to be that active outreach,” she said. “And how do you make sure people know that there’s this medication, and if you’re at high risk that something can be done?”
A key part of Florida’s pandemic response
In August 2021, Florida opened a series of state-funded treatment sites for eligible people who had been infected or exposed to the virus that causes COVID-19.
Those sites closed in January, after the FDA announced that the two most common types of monoclonal antibodies — ones manufactured by Regeneron and Eli Lilly — were no longer effective against the omicron variant and rescinded authorization for their use. That led the federal government to stop distribution of the two medications over the objections of Gov. Ron DeSantis, who had promoted the treatments and made them central to Florida’s pandemic response.
Between August 2021 and January, the state-funded sites administered more than 212,000 total doses of monoclonal antibodies, said Jeremy Redfern, press secretary for the Florida Department of Health, which coordinates statewide distribution of monoclonal antibodies.
Redfern said DOH relied on indicators of COVID-19 community spread when deciding where to open state-funded monoclonal antibody treatment sites, which included locations in Miami-Dade, Broward and Palm Beach counties where case counts have exceeded other areas of the state during pandemic surges.
“The plan when we had set up for distribution was looking at case rates and positivity rates,” he said. “We would push those medications and those treatments down to those areas where you have the highest case rate, because you are trying to bring down the chance of overwhelming hospitals.”
Florida doesn’t use race, ethnicity in deciding treatments
Redfern said Florida’s strategy for distributing monoclonal antibodies does not use race or ethnicity as a factor and that the state did not have demographic data on those patients who received monoclonal antibodies at state-funded sites or how many people received treatment more than once.
But he added that the state Department of Health prioritizes older individuals in congregate settings, such as nursing homes and other long-term care facilities, for monoclonal antibody treatments.
“Our big priority has always been the same, which is we are focused on those we know by the data are more likely to benefit from the treatment, which is people 65 and older,” he said.
Though nursing homes rely on pharmacies as their first resort for COVID-19 medications, Redfern said Florida’s health department will dispatch “strike teams” to administer the therapies at long-term care facilities that are unable to get the drugs.
Redfern said he did not know the number of times strike teams have been dispatched to a Florida nursing home because he had not yet received a response from the other state agencies that partner with DOH to provide monoclonal antibody treatments at long-term care facilities.
Now that the federal government has stopped shipping the two most common types of monoclonal antibodies, Redfern said DOH is prioritizing the remaining treatments that still work against omicron for people aged 65 and older and living in congregate facilities.
“That is the biggest signal in the data that we can find, and those are going to be the remaining group of people that we are going to target,” he said.
The state’s Agency for Health Care Administration, which regulates healthcare facilities, also sent periodic reminders to nursing home administrators advising them of the availability of vaccines and monoclonal antibodies for residents. But the most recent alert regarding monoclonal antibodies was issued in November, before the omicron wave.
Racial, ethnic groups make up small portion of treated
One of the vendors providing monoclonal antibody treatments at state-funded sites is CDR Maguire, a healthcare logistics firm that managed 11 locations in Florida.
Steve Vancore, a CDR spokesman, said in an email that about 135,000 people received monoclonal antibody treatments through the sites managed by the company between August 2021 and January.
Vancore said CDR tracked patients for treatment eligibility under the FDA guidelines and required them to complete a registration form, which he likened to “pre-registration paperwork typical to any primary care doctor’s office visit.”
CDR did not track underlying medical conditions or how many people received treatment more than once, Vancore said. But the company’s aggregated data shows that racial and ethnic minorities made up a small portion of the total treated.
Among the roughly 135,000 people who received monoclonal antibody treatment at a CDR site during the six-month period, 26% identified their race and ethnicity as belonging to a minority group or declined to answer the question, Vancore said.
By age, about 48% of patients were 50 or older, and 66% were 40 or older. Vancore said “0.0008% of treatments provided” experienced an adverse reaction, which would factor to about 105 people if all patients received only one treatment.
Vancore added that CDR has provided 895 monoclonal antibody treatments at Florida nursing homes and other long-term care facilities during the same time period in partnership with the state’s “strike teams.”
‘It’s not going to happen by default’
Though health and healthcare disparities are often examined through race and ethnicity, they also occur due to socioeconomic status, age, geography, language barriers, gender, disability status and other factors.
Prioritizing distribution of COVID-19 therapeutics by age and congregate living facilities makes sense, but states also need to focus on racial and ethnic disparities, said Barnett, who co-authored the research letter analyzing Medicare claims for monoclonal antibody treatments.
Barnett said researchers adjusted the Medicare claims data for factors beyond race and ethnicity to include underlying medical conditions and age, and also found that, “Basically, white patients were the most likely to get the antibodies.” But he added that, “the difference wasn’t quite as stark” as what the CDC’s report showed.
The more stunning find, Barnett said, was that healthy people were far more likely to receive monoclonal antibodies than those who had any of the medical conditions considered to place a person at high risk of hospitalization and death from COVID-19.
“For every single chronic condition where the CDC says, ‘This is a marker for high risk of progression for COVID-19,’ those with that condition were less likely to get monoclonal antibodies,” he said.
Barnett said he suspects the reason is that “the process is so much easier for people who are healthier and have more functional and cognitive reserves to just manage than people who are sicker.”
That’s why Florida needs more than a network of free sites with a first-come, first-served policy, and a distribution strategy that relies on providers to request monoclonal antibodies or the health department to send medications to places where cases are rising, Barnett said.
“Having a color-blind or need-blind strategy, where you think people will ask proportionate to their need, that is just going to result in the status quo being maintained,” he said.
Barnett said states need to find more ways to deliver monoclonal antibodies to patients at home, or proactively reach out to people who are at high risk of severe illness and make it easier for them to schedule an appointment and get to an infusion center. States can also open infusion centers in areas that don’t have them, he said, or provide mobile services.
“Nobody is trying to exclude anybody,” he said, “but there’s still a lack of recognition of the work and the energy necessary to overcome these structural barriers that have been in place for decades. It’s not going to happen by default.”
Barnett said Medicare fee-for-service claims data showed that Florida was “above average, but not that far” in use of monoclonal antibodies. About 9% of patients in Medicare who tested positive for COVID-19 in Florida received treatment compared with the national average of 7%. Rhode Island had the highest use, with 25% of infected Medicare patients receiving the medications.
‘An extremely complex phenomenon’
Dr. Kartik Cherabuddi, an infectious disease physician with the University of Florida Health System, said hospitals have struggled to balance appropriate use of monoclonal antibodies with equitable access to the drugs.
He said some healthcare systems have mined ZIP code data for demographic information while others have used a lottery to determine who gets the scarce medications.
Methods can vary, he said, but they should focus on what’s relevant for the community.
“You start with understanding the population you’re catering to first, and try to understand how you can make the process more inclusive. Reach out to partners in the area that you’ve worked with traditionally over the years. Build a consensus,” he said.
In Florida, that means considering culturally diverse populations, targeting urban and rural areas, and overcoming socio-economic challenges, such as transportation and work schedules, Cherabuddi said.
“You’re dealing with limited resources in a very wide area that has rich geographies. Each town has different demographics, different access to care, poverty levels,” he said. “It’s an extremely complex phenomenon.”
UF created a “hub-and-spoke model,” Cherabuddi said, that uses mobile vans and partnerships with community health centers to increase access to monoclonal antibodies, vaccines and testing.
But reaching people where they live and work is just the start, he said.
Cherabuddi said it’s “an extremely tough process” for doctors and healthcare professionals to educate patients to recognize symptoms and get treatment within three to five days, when monoclonal antibodies are most effective. The drugs are not authorized for use in patients hospitalized due to COVID-19.
For many Floridians, particularly those who lack health insurance or adequate healthcare facilities in their neighborhoods, scheduling treatment early can be more difficult than just waiting until the disease becomes severe enough to go to the emergency room, Cherabuddi said.
“That’s where the more hurdles a community faces, the less likely they are to receive medication like monoclonal antibodies,” he said.
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