Michigan’s current supply of the only antibody therapy that effectively treats the omicron variant won’t be nearly enough for the thousands of COVID-19 patients expected to need the potentially life saving medication in the coming weeks, health experts say.
“Literally at this point in time when it's needed the most, we will lose 80% of our monoclonal antibody treatment options,” said Dr. Bruce Muma, the CEO of Henry Ford Physician Network and director of the system's monoclonal antibodies program.
Clinical data show the three monoclonal antibodies, or mAbs, currently available can be highly effective at preventing hospitalization and death in high-risk patients infected with the delta variant. And they’ve been a crucial tool during Michigan’s current surge: for the last month, 4,000 to 6,000 patients have been receiving monoclonal antibodies each week, according to state data.
But lab tests have shown two of the three types of antibodies on the market (the ones made by Eli Lilly and Regeneron, respectively) aren’t effective against the omicron variant. And while state health officials are stockpiling Sotrovimab, the one antibody that does work, they’ll only have about 4,000 doses on hand before the new year.
“As we see the [omicron] variant increase, though, we know that we will not have enough supply to meet demand for that at this time,” says Michigan Department of Health and Human Services Director Elizabeth Hertel.
Federal officials say they expect to have more Sotrovimab to allocate to states in the first week of January, but reportedly warn it will still be a limited supply.
That’s a devastating blow to Michigan’s health system, which is already stretched beyond capacity.
“I just don't want to think about it because it will bring me to tears,” said Dr. Muma. “But I think about all the people that are going to get infected with omicron. And the ones that are at highest risk, are not going to have access to treatment with the monoclonal antibodies.
“They're going to be afraid. Some of them are going to get sick and end up in the hospital. And when they get to the hospital, they're not going to find any beds. They're going to be waiting in the E.R. They're going to be in the waiting rooms, they're going to be in stretchers, in the hallway. And I just think about the fear and the suffering that is to some extent unnecessary, and it just breaks my heart.”
What was a staffing shortage will now become a supply shortage, too
For months now, demand for monoclonal antibodies has been surging, doctors say. The patient hotline for the treatment at Henry Ford Health System is ringing practically nonstop, said Dr. Muma, but they’re struggling to find enough people to even answer all the calls.
“You look at the volume of calls that we're getting, at Henry Ford we’re getting about 200 calls a day,” said Dr. Muma. “We're infusing about 120 a day. So we have a little bit more than half of the demand [met].”
Until now, the biggest limitation on getting these treatments has been staffing shortages.
Monoclonal antibodies require a lot of work on the back end: figuring out which patients are eligible for the treatment, calling them, getting them scheduled, administering the doses, cleaning the room afterwards, etc.
That’s because mAbs are primarily given via an intravenous infusion, usually over the course of half an hour, followed by a one hour observation period. And they’re only approved for COVID patients with mild-to-moderate symptoms, who are also at higher risk of getting severely ill. (That includes those over the age of 65, and people with diabetes, lung disease, chronic heart conditions, obesity, or who are immunocompromised.)
“The demand has been unattainable,” said Dr. Lindsay Petty, an infectious disease expert and the medical director of Michigan Medicine’s monoclonal antibody program. Like other hospitals, staffing shortages have forced them to ration the treatment, restricting access to only those with the highest risk of hospitalization.
“There are patients that we cannot treat, and that other health care systems cannot treat. Patients who call us, who have called many other places first, seeking it out. Which feels terrible. It’s not how anyone wants to practice medicine.”
Hospitals and EMS teams have tried to make it easier and less-labor intensive, from expanding clinics, to setting up drive-thru treatment, and having EMS teams administer the antibodies to patients in their homes.
That’s how Ellen Mikulski and her husband, Jim, received the treatment in mid-November. They live in a rural part of Lapeer County, and are both over 70. When Jim tested positive for COVID, their doctor put him on the waitlist for monoclonal antibodies. But they were amazed when a young EMT pulled up to their house in a big white ambulance, and told Jim to sit somewhere comfortable.
“We called her our ‘angel of mercy,’” Ellen said. “She hooked him up to this IV. It was really a magical experience. She was so good and so confident.”
Ellen, a cancer survivor with a weakened immune system, was also experiencing COVID symptoms at the time, too. She was scheduled to get a COVID test later that day, but her doctor had already signed her up for the treatment as well. The EMT paged through her list of patient names, Ellen said, but couldn’t find her.
“She said, ‘Well, I’m going to make this work.’ And she…went ahead and hooked me up to an IV in the living room, too…We kept calling her a MacGyver. She wouldn’t know [who that is] because she’s quite young. But she's whipping these cords out and tying up an IV and getting a paperclip and hanging it (to the IV pull). She was amazing.”
Both the Mikulskis still have a persistent cough and feel a bit run down, Ellen said. But they think the treatment may have helped keep them out of the hospital, or worse.
“It could have been much worse. That’s what we keep saying.”
When do you stop treating delta, and start treating omicron?
At a certain point in the coming days or weeks, the predominant strain in Michigan will flip from delta, to omicron. (Petty thinks it’ll be before the new year.)
“The number of labs, including our state lab doing things sequencing on samples is significant,” said Hertel, the MDHHS director. “So we will know when we have reached the point where we can safely say that we believe that it is the dominant variant in the state.”
Until then, health systems are trying to use up as much of the monoclonal antibodies that aren’t effective against omicron as they can. They know time is running out.
“Step one is our decision of when we switch to Sotrovimab only,” Petty said. “And we’ve been reserving it for the last couple of weeks in preparation for this. That's a hard decision, because we know that our data and sequencing variants lag in real time. And the doubling time of omicron is just, it's unreal…
“And so [we will be] making a decision about when we need to switch to make sure that we're giving the most effective therapy to patients, realizing that once we make the switch, we're more likely to have even less infusion slots and less treatment available. It’s a hard decision.”
When supplies are so limited, who gets treated?
The second decision, she said, will be: once supplies are limited to just one type of antibody, who gets it?
“It’s the most difficult emotion that you can imagine for anybody in health care to say: we don't have enough, we have to restrict, we have to ration,” Muma said. “It’s incredibly painful for us and…there's no easy answer here.”
MDHHS is weighing whether to release guidelines for health systems to determine which patients need sotrovimab the most, Muma and Petty said. Currently, Michigan Medicine is including pregnant women in the high-priority category. But Muma said patients who are older, immunocompromised, or have chronic lung disease will likely top the list.
“So most people [in other health systems] have sort of drawn the line there,” he said. “We haven't yet drawn that line. And we're sort of waiting to see what the state's recommendations are and what happens with Sotrovimab. We haven't yet drawn that line, but that's probably where the line will be.”
Looking ahead, Muma is praying that omicron will be less severe than delta — and that maybe, just maybe, Michigan’s health system isn’t further overwhelmed.
“That's kind of the only hopeful thought that I can have at this point, is that even if by some miracle [omicron is less severe and] delta will start to abate, just in time to sort of protect the hospitals and the emergency rooms.”
Because even before omicron fully hits Michigan, hospitals are full.
“We are at a breaking point,” he said. “We’re in a crisis situation. So we don’t have the luxury of allowing any worsening of the surge, or any new surge from omicron, because we just don’t have the capacity to handle it.”
The biggest thing people can do to reduce hospitalizations, health experts agree, is to get vaccinated.
“You don’t want to be in a position where you need monoclonal antibody treatment, and you can’t get it,” Petty said. “And the way you can prevent that is getting vaccinated. That’s our best tool. Certainly social distancing, masking and all that. But if there was ever a reason to get vaccinated, we’re there.”
