Federal officials on Tuesday plan to begin shipping thousands of doses of the monoclonal antibody drug made famous when President Donald Trump praised it after his COVID-19 recovery. But experts worry the drug could be out of reach for some of the people it could most help, and may even exacerbate the pandemic's racial and economic disparities.
When Trump praised the experimental drug made by Regeneron Pharmaceuticals in October, he promised it would be widely available for free. But widespread distribution isn't possible because of limited manufacturing of the newly developed drug.
"It is quite possible that inequities in access to monoclonal antibodies and other novel therapies will increase already well-documented health care disparities," wrote Robert Goldstein and Rochelle Walensky, infectious diseases doctors at Massachusetts General Hospital, in a Nov. 11 Journal of the American Medical Association article, noting that millions lost their employee-sponsored health insurance this year, including some who remain uninsured. That is likely to have worsened inequality in coverage for Black and Latino people.
The treatment, a combination of casirivimab and imdevimab, was authorized on Saturday for emergency use during the COVID-19 pandemic. That follows an emergency use authorization and similar government distribution plan for bamlanivimab, a separate monoclonal antibody drug manufactured by Eli Lilly & Co., two weeks ago.
Both treatments are being distributed to states each week proportional to their share of national cases over the prior seven days, Operation Warp Speed announced Monday. But this week's supply — 30,000 courses of the Regeneron drug and 50,000 courses of the Eli Lilly drug — will be far outstripped by cases, which have approached 200,000 per day this week.
The drugs have similar, tongue-twisting names and work in a similar way, according to Food and Drug Administration official Janet Woodcock, who leads the development of drugs for Operation Warp Speed, the Trump administration's initiative to spur the development of COVID-19 treatments and vaccines. The antibodies were identified and replicated for their potential to neutralize the novel coronavirus. The drug is administered in an outpatient setting via infusion to people who are still in the mild or moderate stages of the disease, but whose medical histories or age make them more susceptible to getting worse.
Little is known from Eli Lilly and Regeneron press releases about which patients the drug is most effective in. But experts have emphasized that it should go to the people most vulnerable to severe disease.
"We need to provide the drugs to the people who have been most affected, and as it's been said many, many times, that's disproportionately racial and ethnic minorities and the poor," said Rajesh Gandhi, a Harvard Medical School professor of medicine who helps write the Infectious Diseases Society of America's COVID-19 treatment guidance. "It's important that as the drugs are administered, data is being collected on how they're being used so that corrections can be made if we do see inequitable distribution."
The National Institutes of Health, while saying more evidence is needed to recommend the drug, says "efforts should be made to ensure that communities most affected by COVID-19 have equitable access."
In deals worth hundreds of millions of public dollars, Operation Warp Speed reserved 300,000 vials of Eli Lilly's drug and up to 300,000 doses of the Regeneron drug, so many patients don't have to directly pay for the drug itself. But depending on their insurance, some patients will pay for the drug's administration, and that could cost $300 or more, according to Operation Warp Speed.
There are a number of unresolved challenges to making the drug widely available. The drugs are the only treatments available for non-hospitalized patients, but must be administered at a hospital or infusion center with adequate staff, supplies, and medication if there is a severe adverse reaction, and infection control procedures.
That means that people in the best position to get monoclonal antibodies are likely to have insurance, regular access to the health care system and a medical provider with knowledge of the latest treatments, and access to a car.
"If I don't have a car, if I'm mildly symptomatic, how do I get my monoclonal antibody infusion? If I’m going to get on a bus…, that could also spread it to other people in the community," said Adarsh Bhimraj, a Cleveland Clinic infectious disease specialist who also helps write IDSA treatment guidelines.
Asked whether monoclonal antibody treatments could increase racial and economic disparities, Operation Warp Speed officials stressed that uninsured patients should be able to seek the treatment without a copay under the Provider Relief Fund created earlier this year, which the Trump administration has said should be used to ensure free COVID-19 treatment for uninsured patients.
But the fund has been plagued with obstacles, as it's far from clear hospitals have prioritized these patients for COVID-19 care or universally informed them about this option.
The IDSA is exploring financial incentives for hospitals and other providers to "do the right thing" and prioritize poor patients, according to Bhimraj.
Woodcock told reporters Monday that people without a primary care physician could access the drug at emergency departments. She said administration officials could not yet release a list of locations that would make the drug available because they need more information.
"The COVID-19 pandemic has disproportionately affected racial minorities and people of low socioeconomic status. Those are the neighborhoods where it might be more difficult to deliver the monoclonal antibodies," Bhimraj said.