COVID-19 monoclonal antibody therapy gets even harder to find in Michigan from The Detroit Free Press

The supply of monoclonal antibodies has grown increasingly tight in Michigan as the omicron coronavirus variant spreads, pushing some health care systems to further restrict eligibility for a treatment that reduces the risk of hospitalization and death from COVID-19.

“The demand still dramatically outpaces the supply,” said Dr. Bruce Muma, president and CEO of the Henry Ford Health System Physician Network.

When the Detroit-based health system’s stock of monoclonal antibodies dwindled to about 550 doses on Monday, he said Henry Ford had to further prioritize who could get treatments to ensure they wouldn’t run out.

“We are counting every dose,” said Muma, who is clinical leader of the health system’s monoclonal antibody program. “We are counting every patient scheduled and we’re balancing it out across all of our infusion sites.”

The supply crunch comes as the state broke a pandemic record for new single-day cases this week. An average of 12,929 confirmed cases were reported for both Tuesday and Wednesday. The previous record was set Nov. 20, 2020, when 9,779 new daily cases were reported, according to a Free Press analysis of state data.

Henry Ford had been following state health department guidelines for prioritizing which  patients should get the treatments, but had to further clamp down on even the most narrow “red level” recommendations to stretch its remaining doses of sotrovimab, the monoclonal antibody product made by Vir Biotechnology and GlaxoSmithKline.

Sotrovimab is the only monoclonal antibody therapy on the market in the U.S. that’s shown in lab studies to be effective against the omicron variant. The treatment must be given by infusion within seven to 10 days of the onset of COVID-19 symptoms for it to work.

Both Henry Ford and Michigan Medicine have stopped using monoclonal antibodies made by Eli Lilly and Regeneron because evidence suggests that while they were effective in treating the delta variant of the virus, they are less potent against omicron.

For that reason, and because the omicron strain is gaining prevalence quickly in the U.S., the federal government announced last week it will pause future shipments of the Eli Lilly and Regeneron monoclonal antibodies — further tightening an already pinched market.

It’s hard to get an accurate real-time measurement of how widespread the omicron variant is in Michigan right now, said Chelsea Wuth, a spokesperson for the state Department of Health and Human Services. That’s because only a very small number of coronavirus test samples undergo genetic sequencing to determine variant type — a process that can take more than a week to complete.

“Some of the dominance questions are complicated to answer because we have a 1-2 week lag on sequencing, plus the CDC’s tracking tool is based upon a modeling approach,” she said. “The models may be correct, but it will take a bit of time to know based on real-world sequencing.”

As of Wednesday, the state health department had confirmed 75 Michigan omicron cases through genetic sequencing. However, that is estimated to be only a small fraction of the total number of cases of the strain in the state.

The U.S. Centers for Disease Control and Prevention reported that as of Dec. 25, the omicron variant accounted for about 59% of all new cases nationally.

As of Wednesday, the state health department continued to report that the delta variant remained dominant in Michigan, and had not yet broadly recommended hospitals limit monoclonal antibody therapy to only sotrovimab.

Michigan Medicine did not answer questions from the Free Press asking it to quantify its supply of sotrovimab or detail how long that supply might last. Nor did the Ann Arbor-based health system detail its criteria to qualify for treatment.

However, spokesperson Mary Masson issued the following statement:

“Due to rising circulation of the omicron variant locally, Michigan Medicine switched last week to using Sotrovimab. At Michigan Medicine, we have been using more restrictive eligibility criteria prior to this drug limitation due to patient demand far exceeding the capacity for treatment slots. Over the coming week, we plan to develop further eligibility restrictions using the NIH (National Institutes of Health) guidance, given even higher demand driven by omicron. We are regularly reassessing our limited supply of Sotrovimab.”

At Henry Ford, Muma said it had to move this week to what it calls “restricted red criteria.”

“We did that out of the sheer critical status of our supply of monoclonal antibody. … That would be a disaster for us to fully run out, so hopefully that won’t happen.”

That means at Henry Ford, only the people who are at the very highest risk for severe disease from COVID-19 are eligible for an infusion of sotrovimab. That includes people who:

• Are pregnant
• Have a chronic lung disease requiring supplemental oxygen
• Have a body mass index of 40 or higher
• Are taking particular drugs that case the highest levels of immunosuppression
• Are 65 or older
• Are on dialysis

In addition, people who are unvaccinated or partially vaccinated are at higher risk of severe disease or death from the virus, Muma said. That means they may also qualify for monoclonal antibody treatment if they have:

• Cardiovascular disease
• Diabetes
• Stage 3 renal disease

The hope, Muma said, is that a new shipment of sotrovimab will arrive early next week to bolster supply. But he acknowledged there’s no guarantee if or when more will come.

“We don’t know what our supply is going to be,” Muma said.

Munson Healthcare is continuing to use all three monoclonal antibody treatments “until we receive more regional data on the prevalence of the Omicron variant,” said Dianne Michalek, the Traverse-City-based health system’s chief marketing and communications officer, in a statement to the Free Press.

“We currently have strict criteria to prioritize high-risk groups for these therapies and have supply for two to four weeks should no other additional supply arrive. However, this continues to be a fluid situation with availability of supply and guidance on use of these therapies changing frequently.”

Still, Dr. Christine Nefcy, Munson’s chief medical officer, said hard choices have to be made.

“The availability of monoclonal antibody just in general is limited,” she said. “We have to order it on a week-to-week basis. Sometimes, we get what we ask for. Sometimes we don’t.

“We’re seeing limitation across the country and especially as we see surges in other parts of the country, the demand there goes up. … Supply chain issues are big. We are going to be further prioritizing who can get those monoclonal antibody treatments.”

Last week, the federal government distributed 55,000 doses of sotrovimab to states. Michigan’s most recent shipment included 3,228 doses, Wuth said.

An additional 300,000 doses — to be split up among all the states and territories — are to be distributed in January, federal health officials said, though it is not clear how much will be allotted to Michigan.

Spectrum Health also is continuing to use all three available monoclonal antibody therapies, but with some caveats, said Dr. Gordana Simeunovic, an infectious disease specialist for the Grand Rapids-based health system.

“We are well aware that omicron is predominant in the U.S. It is predominant in the whole Midwest region. But in our area here … it is estimated omicron is still less than 25%,” she said of the western side of the state.

“If we use Regeneron or Lilly monoclonal antibodies, we still believe that three out of four treated patients may benefit from treatment rather than not offering anything.

“We are still using it. We can use up supplies that we have on hand and when we run out, then that’s it.”

Spectrum had only a few hundred doses of sotrovimab as of Tuesday.

“Under normal circumstances, we use several hundred (doses) in one week,” Simeunovic said. “So we are really trying at this point to prioritize patients and to give the sotrovimab to the patients who are highest possible risk for severe disease.

“Simply, we have to prioritize. There is not enough medication for everybody.”

Patients with severely compromised immune systems are getting top priority for the sotrovimab at Spectrum, she said. Other patients who qualify for monoclonal antibody treatment because they have other underlying health conditions are getting the remaining stock of Eli Lilly and Regeneron monoclonal antibodies, Simeunovic said.

“We are trying to make sure that the monoclonal antibodies are still active, so we are calling patients randomly after 36 to 48 hours … to check how they’re doing,” she said. “If somebody is not doing well, that could be the sign that the therapy is not working.”

As of Tuesday, none of the patients from Spectrum Health who’d gotten Eli Lilly or Regeneron antibodies reported worsening COVID-19 symptoms, she said.

“The majority of patients were feeling significantly better,” Simeunovic said. “That’s what we expect to see. And a few of them were feeling the same, but none of the patients that we called were feeling worse or needed ER admission or hospitalization.”

Unvaccinated patients also get priority when there is limited supply of antibodies under NIH guidelines, she said, because they are more likely to be hospitalized or die from COVID-19 than vaccinated people.

“It is not up to me to judge if somebody is not vaccinated,” Simeunovic said. “If somebody is sick, I still have to treat them and I still have to assess the risk objectively. I cannot tell them: ‘You are unvaccinated. I will not treat you.’ And unvaccinated patients are definitely at higher risk for severe disease than vaccinated people.”

If Spectrum were to switch to treating patients with only the sotrovimab monoclonal antibody therapy, “we would probably run out in a few days,” Simeunovic said.

“Since we are really trying to balance risk and give the sickest patients with highest risk sotrovimab and everybody else the other monoclonal antibodies, and make sure they are still doing well, we’ll have supply for probably a few weeks.”

While monoclonal antibodies have been shown to work, Simeunovic said they’re not a substitute for vaccination.

“Until the majority of us gets vaccinated, this won’t end,” she said. “The ticket to get out of pandemic is to get everybody vaccinated.

“We have all the needed tools now to fight this and we are just not choosing them. … It is not over. We know that it is not over. My hospital is full. We are in a red zone and people are walking around like nothing is happening, unvaccinated and without masks.

“We should learn something from the last two years. This is everybody’s responsibility. Get vaccinated. Wear a mask. Minimize exposure. We really have to work together. … Everybody’s responsible. The pandemic is not over, not even close.”

Read, “COVID-19 monoclonal antibody therapy gets even harder to find in Michigan” from the Detroit Free Press.

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