Are monoclonal antibodies here? Yes, but not everyone can get them

Monoclonal antibody therapeutics are authorized by the Food and Drug Administration — the same kind of authorization the FDA gave to Moderna and Johnson & Johnson COVID-19 vaccines. The monoclonal antibodies are not yet FDA-approved like the Pfizer vaccine is.

Idaho health officials are working to make the drug available to people at greatest risk of hospitalization. However, they warn: monoclonal antibodies are no substitute for a vaccine. The drugs cannot prevent illness, they're not as effective as COVID-19 vaccination at keeping people out of the hospital, and they're not abundantly available like the vaccines are.

Not everyone can take them, either. They must be given shortly after infection — only to people at risk of being hospitalized, before they need to be hospitalized.

They're also far more costly than the COVID-19 vaccine. Treatments and vaccines are provided at no cost to the patient. But the U.S. government agreed to pay $2,100 per dose for the antibody treatments, according to a Regeneron news release. That's about 80 times the reported price for a dose of vaccine, which also takes less time, space and work to administer than the infusions.

Idahoans with COVID-19 have received thousands of courses of these treatments since December 2020, according to federal data. Their use began slowly in Idaho, with dozens of infusions or injections given each week, then ebbing and flowing.

About a month ago, they took off, and the number rose to hundreds of doses per week.

Idaho pledged $1.8 million to make treatments more accessible

Gov. Brad Little last month announced plans to stand up three state-sponsored treatment centers, in addition to the dozens of hospitals, clinics and infusion centers already giving them to Idaho patients. Two of the new, state-sponsored centers have opened in East Idaho, through Mountain View Hospital in Idaho Falls, and in North Idaho.

A total of $1.8 million in state funds was set aside for the state-sponsored sites, according to the governor's office. The state has awarded the two existing sites $600,000 each, to help cover the costs of staffing, equipment, space and supplies.

The state-sponsored monoclonal antibody centers are expected to serve eligible COVID-19 patients from the community in general, not just patients of a certain hospital or clinic, the governor's office said.

“Monoclonal antibody treatments are one more tool in our toolbox to save lives and reduce hospitalizations," Little said in a news release Wednesday after touring the North Idaho site, operated by Heritage Health and Northwest Specialty Hospital at the Coeur d'Alene Fairgrounds.

The surge in demand, and subsequent need to mete out the supply, came just as Idaho was preparing a state-sponsored monoclonal antibody center for the Treasure Valley. To ensure that existing sites have enough supply, state officials paused work on the Treasure Valley center.

Health care providers in southern and southwestern Idaho still have multiple places to send patients. St. Luke's Health System, for example, has infusion sites from the Magic Valley to Fruitland.

“I would remind everybody that, because of what COVID is doing nationwide, there's a supply crunch," said Idaho Gov. Brad Little on a telephone town hall Tuesday. “And it's a lot easier to get vaccinated, to talk to your doctor and make the choice to get vaccinated, than to wait and take the chance that there may not be monoclonal antibodies (available). As a reminder, the Pfizer vaccine has got full approval, but the monoclonal antibody is still under an emergency use authorization. … We're putting resources into it, but it's not as good as the vaccines."

What are monoclonal antibodies?

The drug REGEN-COV (casirivimab/imdevimab) is “by far the most common to be used," said Dr. Laura McGeorge, an internal medicine physician at St. Luke's Health System and director of the health system's COVID-19 Recovery Clinic.

“When someone gets COVID-19, it takes a little time for their antibodies to kick in, so this is a way that we can kind of synthetically add more antibodies to help reduce the likelihood of their ending up in the hospital," McGeorge said.

So far, the drug remains effective against the delta variant, but that could change. Every time the coronavirus replicates in the human body, it can mutate in a way that makes it easier for the virus to evade the synthetic antibodies.

Where and how do Idahoans get these drugs?

The infusions and injections are available through about 30 health care organizations in the state.

Health and Welfare Director Dave Jeppesen said Tuesday that while the treatments are free for the patient, not everyone can get them.

To be eligible, a person must:

• Test positive for COVID-19, using a PCR test.
• Have risk factors for hospitalization, such as older age, obesity or high-risk chronic health conditions.
• Be early in their course of illness. The drugs only work if they're given within 10 days of the first COVID-19 symptoms.

“So if you think you're a candidate, you need to talk to your doctor immediately after getting a positive test," Jeppesen said.

McGeorge told the Sun that treatment should begin early, “the sooner the better."

But people cannot walk into a center or a hospital to get the treatments. They have to be referred by a doctor or other health care provider, after their positive test and after evaluation of risk factors — but before the 10-day window has passed.

“You cannot self-refer as a patient," McGeorge said.

She urged patients who test positive for COVID-19 and are referred for monoclonal antibody treatments to answer their phones. The infusion schedulers say patients aren't answering their calls or checking for messages and risk missing out on a potentially life-saving medication, she said.

To keep nurses at the bedside, St. Luke's deployed pharmacists to do infusions

St. Luke's began offering the medications to patients as soon as they became available to order, said Scott Milner, St. Luke's senior pharmacy director.

“Everywhere we have a footprint, we've been doing infusions," he said.

The infusions are a challenge, though, especially during a health care crisis. The drugs require a nurse or other qualified health professional to administer. They take time — time for the infusion, plus a long observation period after the infusion. And COVID-19 patients cannot mix with other patients, so the infusion sites must be in their own, isolated space.

As they went into Labor Day weekend and cases surged, the health system realized it needed to ramp up capacity to treat Idahoans, Milner said.

So, they came up with a plan. They found space, and tapped pharmacists to help administer the drugs. The pharmacists now work long shifts, in heavy PPE, but they've managed to treat dozens of patients a day. They opened a clinic in Meridian that “has really been key," Milner said.

St. Luke's went from administering about 60 treatments a week, to treating about 50 patients on a recent Wednesday.

“We feel that this therapy is doing a great service to the community," Milner said. “This is a lifeline. We unfortunately have a limited resource of not only the medication but also the chairs in which to administer it. And so, we are working with our providers to make sure that we are … prioritizing this for the patients that are really at most risk (of hospitalization or death) and making sure we get them in as early" as possible.

That short supply has caused concern.

Ada County Commissioner Rod Beck recently called a meeting to try to find ways for the county to help facilitate a local treatment center. He learned that one of the big issues was the shift in how the medications would be doled out to states.

He wants Ada County to partner with a local health care provider, such as Terry Reilly Health Services, to open a site like the one in North Idaho.

He told the Sun that he agrees with public health experts: vaccination is the best way to protect oneself from COVID-19.

But, he said, the reality is that many Idahoans are forgoing vaccinations, and he wants to have an option to save their lives without them adding to the hospital crisis.

The medications are “particularly helpful now," McGeorge said. “If we think how burdened our hospitals are, anything we can do to reduce the likelihood of someone being hospitalized, that's good."

She reiterated that it's a better idea not to get COVID-19 in the first place.

Getting vaccinated, following public health guidelines and wearing masks can prevent a person from ever needing a monoclonal antibody treatment, McGeorge said.

“It's kind of like, if you have a great car with great airbags, it's still better to avoid the accident in the first place," she said. “So the airbags might reduce the likelihood you're going to end up in the hospital, but still, I think we would all agree, better to not get in the accident in the first place — and especially now that the hospitals are so burdened."

Idaho Capital Sun is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. Idaho Capital Sun maintains editorial independence. Contact Editor Christine Lords for questions: info@idahocapitalsun.com. Follow Idaho Capital Sun on Facebook and Twitter.