A tiny Florida company got more of a scarce Covid therapy than some big hospitals, raising equity questions

The Covid-19 treatments came as a surprise, care of the Florida Department of Health: six big, mysterious boxes that showed up at Nicholas Suite’s iCare Mobile Medicine clinic near Miami on the morning of Dec. 24. “We were wondering, what’s this? Who sent us presents? Did Santa land on the roof?” he said. “Then we opened it up and thought, ‘This is Evusheld! My goodness!'”

To some infectious disease doctors, that shipment has worrisome implications. When they looked at a government database, they saw that Suite’s tiny private company had gotten more of the federal supply of this scarce therapy than some of Florida’s major hospitals. In fact, iCare Mobile received enough for 264 courses — the most the health department sent to any of the state’s providers in its first shipment of Evusheld.

Evusheld is a precious substance, a cocktail of two monoclonal antibodies that may provide some six months of protection against Covid-19 for people too immunocompromised to mount a strong response to a vaccine, like those undergoing chemotherapy or taking immune-suppressing drugs after an organ transplant, or for the small number of people who’ve had severe adverse reactions to Covid immunizations. The federal government has been portioning out the small supplies it has to states, which have then been sending them to medical centers.

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There isn’t nearly enough for everyone who’s eligible for the therapy. Patients have been clamoring for it. Big academic hospitals have been rationing it.

But here it was at iCare Mobile Medicine which, Suite says, has six full-time practitioners on staff: a medical assistant, two paramedics, two physician assistants, and himself, the only physician. The company had launched during the pandemic to make urgent-care house calls, dealing with issues like burns and bouts of diarrhea, so patients didn’t have to risk going to a hospital. Its services often weren’t covered by insurance, paid for instead with cash or credit card. The team then expanded into giving Covid-19 vaccines and therapies. Sometimes it was hired to set up a coronavirus testing table outside private parties, Suite said, including those of South Beach’s celebrity set.

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“Whoever does not have a negative test does not go in,” Suite said. “So we’re kind of like the medical bouncers.”

Soon after the surprise delivery, the clinic announced it would also provide injections of Evusheld — and the phones have been ringing off the hook. The drug is free to patients and, while insurers may reimburse doctors for administering it, iCare’s priority was to get people injected and it is now working on the billing. Insurance is not a requirement, Suite said.

Yet some infectious disease doctors worry that attempts to fairly distribute a scarce medication to the patients who’d benefit most from it might be undermined if some of the doses are going to private companies that weren’t already caring for transplant and cancer patients.

“It raises really significant questions about the fair and equitable allocation of this therapy,” said Michael Ison, a professor in the infectious diseases and organ transplantation divisions at Northwestern University Feinberg School of Medicine.

“If you think about what is the most efficient way of getting patients a protective product, it’s all hands on deck at this stage. But that has to be balanced against a real caution not to just give it to people who are the most financially able to get it. Otherwise, that flies in the face of the equitable distribution that the hospitals are trying to do — and hopefully, that the state’s trying to do,” said Cameron Wolfe, associate professor of medicine in the infectious disease division at Duke University, who chairs the university’s Covid-19 therapeutics committee.

Wolfe worries that different rationing systems in different places will let some people maneuver around the rules in ways that others can’t. “People with resources find out where it’s available, and they go hunting. I’ve had emails from people from Ohio going, ‘Hey, I see you’ve got this drug, can we drive down to Duke and get some?'”

But Duke doesn’t have nearly enough of the monoclonal antibody cocktail for its own patients who would fit the broad criteria laid out by the Food and Drug Administration. Duke’s doctors treat thousands of people who are immunocompromised; their first allocation of Evusheld included about 300 doses. But there are different levels of being immunocompromised, and Wolfe and his colleagues have taken that into account. One example of who might be prioritized for getting Evusheld are people whose cancer or transplant or autoimmune illness requires them to take medications that have been clearly shown to inhibit the immune system’s response to vaccines.

Medicines like that “directly inhibit your body’s ability to make antibodies. That’s the way they’re designed. And so people don’t make antibodies to vaccines,” Wolfe said, adding that this isn’t necessarily true for everyone who has gotten a kidney transplant or who is on chemotherapy.

At iCare Mobile Medicine, the criteria for this prophylactic treatment are less stringent than those at Duke and other similar centers. Instead, they’re the more general ones the FDA laid out. If you’re immunocompromised, you don’t have Covid-19, and you live at least part of the year in Florida, Suite explained, then you can get Evusheld. “We’re not triaging people to say, ‘Well, you look really sick or you’re really old.’ We are going by the criteria that the government and the manufacturer have set forth and it really boils down to being first come, first served.”

Figuring out a fair system of distribution is complex. Some doctors feel it’s ethically questionable for people who can afford the travel to become Evusheld tourists, though in some cases patients may be in the high priority category even though they live a few states away from their transplant center and so might be traveling without jumping the carefully thought-out line. “We became aware of this because at least two of our patients here in Illinois have flown to Florida to this private clinic to get Evusheld,” said Ison, the Northwestern physician, referring to iCare.

Suite said his clinic does not give the drug to permanent residents of other states, though it does provide it to snowbirds who live part of the year in Florida and part of the year elsewhere. He and his colleagues had pestered the state health department to be able to get Covid vaccines for the patients they were seeing in their homes, and they succeeded. That laid the groundwork for its Evusheld request, Suite said. “Our name was well known in the health department: ‘Oh, yeah, these guys really bug us a lot. They want stuff to help their patients.'” They were surprised that they actually got some of the prophylactic, but thrilled at the thought of being able to help South Florida’s retirees, many of whom have dealt with cancer or transplantation.

Suite agrees that giving the most vulnerable patients top priority is vital, but he isn’t sure that big university-affiliated hospitals are necessarily the best or only route to ensure equitable access. “The one constant current of concern that I perceived was that there are a lot of community oncologists and community physicians that do transplants outside of major academic centers,” he said. Their patients, he continued, “are traditionally marginalized by those same academic medical centers.”

Many hospitals, Suite said, were refusing to give Evusheld to patients who weren’t already receiving treatment from them, as well as to some who were, and iCare became an alternative. “We have patients coming from Orlando, from Daytona Beach, from the west coast of Florida like Tampa, for example: people who were already receiving care for their transplant or for their cancer at major centers around the state of Florida, but they could not get in at even their own facility. Because there was just not enough of a supply,” he said.

When reached by phone on Saturday, a Florida Department of Health official confirmed that iCare had indeed received the state’s largest allotment of Evusheld in the first delivery. How much of the treatment went to each site was determined by the population density of the county as well the number of clinics that would be administering the prophylactic treatment. But a medical center’s readiness is also part of the equation, he explained.

When the federal government allocates a certain number of Evusheld courses to a state — 3,120, in Florida’s case — they don’t all get shipped all at once. Instead, the state reaches out to hospitals and clinics, which then respond to say they are — or aren’t — set to administer the therapy. Only then does the shipment go out. The internal approval can take longer at some medical centers than others. A tiny operation, the official explained, might have less bureaucracy or be less swamped than a behemoth of a hospital. iCare Mobile was especially snappy. “They’ve always just been ready to rock,” he said. As for how patients get chosen to receive the few available doses, he said that that’s up to the FDA’s authorization.

Both Ison and Wolfe see Suite’s point that academic medical centers aren’t always paragons of equity. After all, accessing cancer treatment or a transplant at certain hospitals is often correlated with privilege. They just want to ensure those gaps aren’t made even worse in distributing a scarce resource.

“Giving [Evusheld] to these kinds of concierge services for distribution could be potentially justified to facilitate access to the drugs,” said Ison. But he wondered why not give some to transplant or oncology clinics that may not have gotten any at all, given that their rosters are already full of eligible patients.

“There are definitely going to be people out there who are not well served by academic medical centers. I couldn’t agree more,” said Wolfe. “Hence why I think, What’s the optimal distribution? It’s one where we’re all sort of on the same page as to who is truly in the greatest need. That should be independent of where you see your doctor.”

Editor’s note: This story was updated to include a response from the Florida Department of Health.