Patchwork system for rationing a Covid drug sends immunocompromised patients on a ‘Hunger Games hunt’

The first thing to know about M. is that for her, there was no pre-Delta surge of optimism. She has multiple sclerosis. Every six months, she gets an infusion to destroy her B-cells-gone-haywire and slow the havoc they’re wreaking on her spinal cord and brain. Those are the same B cells that would normally unleash an army of protective antibodies in response to a vaccine. Without them, her best bet to survive Covid was to avoid it — one long, anxious lockdown, as if nothing had changed since March 2020.

Then, right around Christmas, something did change. There was a new glimmer of possibility — a prophylactic treatment called Evusheld, which might give her six months’ worth of the helpful antibodies her own body couldn’t make. The trouble was getting some. An estimated 7 million Americans with impaired immunity were eligible, but the federal government initially bought enough for only a tenth of them — and then, after an outcry, increased the total order to 1.2 million courses.

The big prestigious hospitals where M. usually got care were no help. She was in the highest priority group, one doctor wrote, but there were “over 3,000 patients in this category and less than 100 doses distributed from the state so far, and it is a closed lottery so I do not know where you are on the list.” Same deal from six other medical centers: Don’t call us, we’ll call you.

Instagram turned out to be more fruitful. Searching for “#Evusheld” brought her to an account showing a sunny, curated Floridian life that looked very different from her locked-down Midwestern one. “Parties, tiny slinky dresses, fake boobs,” she said. The pics were so lushly filtered that M. wondered if this person was real. But the Instagrammer responded to a message: Her immunologist had sent her to get the therapy from a small concierge clinic in Hollywood, Fla., called iCare Mobile Medicine, which says it offers Covid vaccines and treatments, in-home, in-hotel, or on-boat doctors’ visits, and “medical bouncer” coronavirus-testing tables for celebrity shindigs. When M. texted the clinic’s number about Evusheld on a Wednesday in early January, the response came quickly: “Are you able to fly down to Florida to be treated this Friday afternoon?”

It was hardly an isolated invitation. One Facebook group for transplant recipients has become a hub of Evusheld intel: The founder knew of two or three members who flew from out-of-state to different clinics in Florida, another few families who drove 8 or 10 hours from Minnesota or Iowa to get injections in South Dakota, and others who zeroed in on a few pharmacies in Virginia. A Microsoft engineer — on leave from work to care for his wife during her lymphoma treatment — wrote software to scrape a confusing federal database, making doses easier to find.

Lurking behind those DIY projects is a mess on a national scale. While lab-dish studies suggest Evusheld works less well against Omicron than previous strains, immunocompromised patients see it as their best shot at Covid prevention. It’s in short supply, but there’s no national system for distributing it equitably, with the federal government divvying it up among states and states divvying it up among medical centers, and medical centers varying in the criteria they use to determine who should get first dibs. Even academic hospitals, adamant as they are about creating an ethical prioritization framework, don’t always agree on the details.

The patchwork creates a crazed, time-zone-spanning scramble, leaving patients frustrated with the lack of reliable information.  “Having a medicine that might be able to help fills us with hope,” said Rob Relyea, the Microsoft engineer, “but having to hunt it down in a Hunger Games hunt is extremely distressing.”

Doctors, too, worry that Evusheld tourism will favor the affluent and the savvy, undermining the careful frameworks they’ve built. Many wonder why the federal government did not initially purchase as much Evusheld as possible. “Whenever we have these kinds of distribution and availability problems, it just worsens the ongoing disparities we have in this country,” said Dorry Segev, a Johns Hopkins transplant surgeon and epidemiologist.

It’s yet another example of the classic American style of pandemic response: Authorities foisting complex moral and public health decisions onto smaller and smaller jurisdictions until they land thuddingly on the individual. M. felt the weight so acutely that she spoke on condition of anonymity, not wanting to reveal even her home state. She didn’t want to take a dose from a deserving Floridian. Then again, she knew she was eligible — not just eligible, but in her own state’s most vulnerable, highest priority group. Earlier in January, there were 216 Covid cases in her daughter’s school. She was a sitting duck. Again and again, she kept asking, “What am I supposed to do?”

The decision is unenviable — no one wants to be the person denying someone care — and it’s often made tacitly, by virtue of who does or does not have insurance, who does or does not have the time and know-how to navigate the murk of medical bureaucracy. For ethicists, those structural inequities will shape the distribution of something scarce like Evusheld unless institutions actively work against them. “Do not base your decisions on a first-come, first-served basis. That’s something that is really clear,” said Faith Fletcher, a bioethicist at Baylor College of Medicine.

Some hospitals try to take those longstanding inequities into account. At the University of Pittsburgh Medical Center, a patient’s priority for Evusheld gets bumped up a little based on how disadvantaged their neighborhood is. “That is not to put them ahead. That is not to give them an advantage by any means. It’s to make them equal,” explained infectious disease pharmacist Erin McCreary. “Because if you just put everyone into a lottery, and everyone gets one chance, but one of those people that had one chance is five times more likely to get the disease — well, that person’s behind.”

After that attempt at rebalancing the scales, UPMC does what many other hospitals are doing: Prioritizing their patients who stand to benefit most — those who are least likely to be protected by vaccines — and then, within those subgroups, creating a lottery. But even those who agree on the general principles often differ when you get down to details. Mayo Clinic has five tiers. UPMC has three. Some see age as an essential attribute to consider, because being elderly is such an important risk factor for dying of Covid-19; others see that as heightening racial disparities, because white patients are more likely than their Black counterparts to live past 65.

Even the medical categories aren’t always clear cut. A framework might start with those whose cancers or life-saving medications deplete their B cells, for instance, making them unable to produce antibodies, and then proceed to those who are less immunocompromised. But, this being the immune system, the variables can get complex fast. Patients who look similar in their medical history can look different in their blood tests.

“Within each diagnosis, you can have different severity of illness,” explained Akilah Jefferson, an allergist-immunologist and bioethicist at University of Arkansas for Medical Sciences. “Just because you have, for instance, common variable immunodeficiency or CVID, which is a very common antibody-based issue — everyone is not the same who has that diagnosis. So trying to manage that has been fairly difficult.”

To Segev, the surgeon at Hopkins, that’s a sign that prioritization plans for the immunocompromised should involve antibody testing, to take what he calls the “guesswork” out of the algorithm. “If you have zero antibodies, that means that it’s unlikely [you’ll] have any relevant memory that can at least give you some head start before you get exposed,” explained Ali Ellebedy, a Washington University immunologist.

The idea isn’t far-fetched from an immunologist’s perspective — but only if you’re looking at it as a binary, distinguishing those who have some antibodies versus those who have none. “Where people can get into trouble is by trying to determine exactly how much is needed for protection. That is a much tougher question to answer and buyer beware if someone claims otherwise,” wrote Deepta Bhattacharya, a University of Arizona immunologist, in an email.

Other clinicians worry that adding antibody testing might create another barrier in getting Evusheld into arms and buttocks at a time when hospitals are overwhelmed and patients are already saying they’re moving too slowly. In some cases, families are simply heading to places where the rationing is less stringent. Some Evusheld travelers are in their hospital’s highest priority group but are done waiting with no information about when their name might be called. Others may be further down the list, but feel no less urgency. Many have little patience for infectious disease specialists’ protests about concierge clinics or pharmacies with looser guidelines.

“I appreciate the concerns about inequities, but when you’re the person who is facing a disease that is all over the place and can kill you — and you don’t have the same defenses that everybody else, including those infectious disease doctors, have — you’re worried about staying alive,” said Mary Anne Razim-FitzSimons, the mother of a kidney transplant recipient. “They’re talking about inequity in distribution, and yet in the United States we have 50 different ways of distributing a scarce resource.” In fact, because some states leave the rationing up to clinics and hospitals, the number is quite a bit higher.

To Razim-FitzSimons, it wasn’t a hard decision. Her daughter Laura is 23 and has a rare autoimmune condition that attacks the kidneys. Laura needed a transplant shortly after she turned 15, and she got one, her father acting as a living donor. By her Minnesota hospital’s standards, she isn’t at the top of the list for Evusheld; she’s immunosuppressed, but not as thoroughly as more recent transplant recipients, and she’s young, putting her in Tier 4. Yet there’s a possibility that a Covid infection could re-trigger her autoimmunity. There is no cure. “There are transplant centers who will not transplant people with this disease, so it’s not surprising that we are desperate to keep this kidney,” her mother said.

Razim-FitzSimons has felt the risks of the pandemic acutely, a constant anxiety that manifests as nausea. She works as a speech-language pathologist in a school, and has no choice but to be there in person. Every day, she tapes a KN95 to the bridge of her nose and cheekbones in the hope that will seal even the tiniest gap.

She was ready to drive over 20 hours to Florida to get Laura some Evusheld, but someone in a patient Facebook group mentioned a clinic in South Dakota that would provide it as long as you had a doctor’s order. She got one from Laura’s transplant team and faxed it to Rapid City on a Monday night. She called the clinic the next morning, to book an appointment. The next day, they got in the car. She and her husband talked about anything and everything except Evusheld, “for fear that we were going to get there and something was going to go wrong. They were going to say, ‘No, you’re out of state, we can’t do this.’” She popped peppermint Life Savers to try to beat back the nausea. Slowly, farmland gave way to the beginnings of the Black Hills.

When Laura got the injections, that Thursday morning, her mother began to cry. Then, after the hour-long observation period, they hit the road. They were trying to beat a snowstorm, and it would take them eight and a half hours to get back home to Minnesota.

She knows that the treatment isn’t perfect, especially against Omicron. The family had a potential exposure a few days ago. “Evusheld will keep her alive, we hope, and out of the hospital, we hope, but it may not save her kidney. Right now, we’re going for alive,” Razim-FitzSimons said. “It’s hard to explain what that does if you’re not experiencing it, that constant worry. People say you just need to put your mask on and get on with your life. It doesn’t work that way for the immunocompromised or their families.”

The ethical questions cut right to the heart of American medicine. M. texted the appointment-booker at iCare Mobile about her ethical qualms, writing “I also don’t want to take away from people that need it that are on the list in Florida.” The reply did not suggest a many-tiered rationing plan. “We are on the honor system when it comes to your health,” it said. “I don’t think people who don’t need it will line up to receive an experimental drug…”

That jibed with what Nicholas Suite, iCare’s medical director, has told STAT, saying that the clinic “steadfastly and solemnly adheres to the strict criteria”  laid out in the Food and Drug Administration’s emergency use authorization and by the manufacturer, but doesn’t prioritize different groups among those patients. If you’re immunocompromised, he said, “yes, we will accommodate you.”

To infectious disease doctors who’ve wracked their brains trying to fairly divvy up what they have among their patients, that sort of breezy approach is dismaying. “That worries me, that it won’t be given fairly, that it won’t be given to the people who need it most,” said Daniel Kaul, the University of Michigan’s director of transplant infectious disease. “Because it may be given to people who have very minimal immunosuppression and are highly likely to respond to vaccines.”

Suite has told STAT that the clinic has offered the drug to snowbirds, but not more temporary out-of-state visitors. When asked about the fact that M.’s text exchange seemed to suggest otherwise, and presented with Kaul’s concerns, Suite wrote, by text message, “We at iCareMM have given Evusheld to a very small number of highly immunosuppressed and immunocompromised out-of-state patients who have indicated part-time residence in Florida.” He added that his team has long embraced Dr. Francis Peabody’s “beloved exhortation to the physicians: ‘The secret of caring for the patient is in caring for the patient.'”

Some critics agree with bits of Suite’s argument. Academic medical centers often offer the injections only to their own patients — and being on that roster might itself correlate with a certain amount of privilege. Those seen at smaller community hospitals may be out of luck if the place where they got their care didn’t receive any Evusheld, for instance. To many, this is a sign that we need a better, more coordinated prioritization system, not a looser one.

Many patients who legitimately qualify for the treatment sang iCare’s praises. Dan Dickinson, an Illinois transplant recipient who flew down to get an injection there, said he was told the clinic “made the promise they’d get shots in the arm quickly. They did that. Their process was very well organized. Small and agile.” He knew of big hospitals that, at the time when he received his Evusheld, hadn’t started giving out doses at all.

For some, the barrier may be their own physician. “They want to get it, but their primary care provider won’t write the script, and their transplant doctor won’t either,” said Janet Handal, the founder of a 1,700-person Facebook group for transplant recipients and immunocompromised patients. In other cases, she said, because hospitals aren’t reaching out proactively about it, patients may not even know it exists.

Rob Relyea, in spite of his herculean data analysis efforts, still has not secured a dose for his wife, though she is on a B-cell-quashing therapy and is theoretically in a high priority group.

M., the midwestern patient who was considering flying down to Florida, has been on the fence. She made an appointment, then she canceled it. She worried about Covid exposure risks involved in the trip. Then she spoke to someone from the clinic, who informed her that the team was no longer accepting out-of-state patients. She asked if she might be able to use the address of a family member in Florida. The person on the other end said she wasn’t sure, she’d have to talk to the medical director about that.