States just got their first shipments of an antibody treatment that could help prevent patients from developing the worst symptoms of COVID-19. But in Utah, the health department is overwhelmed and grappling with the best way to distribute it. Like the rest of the country, it’s battling a devastating surge of COVID-19 cases. Nearly 20 percent of tests done in the state are coming back positive, and hospitals are overcrowded.
“We are not declining allocations of this medication,” Charla Haley, a spokesperson from the Utah Department of Health, said in an email to The Verge. But the health department needs to work through a number of logistical problems before it can organize the treatment, she said. Right now, it has to prioritize other issues, like keeping hospitals running. Other states across the country are navigating similar situations.
The Food and Drug Administration signed off on the drug earlier this month. It’s an antibody treatment called bamlanivimab that’s produced by Eli Lilly. It’s a kind of drug that experts have said for months could be a good way to help patients — a concentrated mix of coronavirus antibodies that could block the virus from replicating, keeping the disease from getting worse. But drugs like bamlanivimab are hard to produce, and even with manufacturing ramping up, there is only a limited number of doses available. Figuring out who could benefit most from the few doses available is also extremely complicated, requiring resources that many health care systems simply don’t have right now.
“This is both the best of times and the worst of times for this therapy to come out,” says Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “We need it because we have so many cases, but on the other hand, everyone is inundated.” The places that have the most cases and could use a treatment the most are also the places with overwhelmed hospitals. “I’m sure it’s a challenge to figure out how this is going to work,” he says.
The first week’s batch of bamlanivimab released by the US Department of Health and Human Services included enough to treat just under 80,000 people. On Tuesday, nearly twice that many COVID-19 cases were reported in the US. The drug is allocated based on the number of cases in each state over the previous seven days. Utah got 1,300 doses in the first weekly batch. It’s averaging over 3,000 cases per day.
“The drug is not making a huge difference for the day-to-day care of the majority of patients, simply because they’re available in such limited quantities,” says Megan Ranney, an emergency physician and associate professor at the Brown University department of emergency medicine. Ranney says the drugs aren’t part of the standard treatment in emergency rooms. There are still some clinical trials running for this and other antibody treatments, so she’s referred a few patients for those. But she says she hasn’t treated patients with antibodies otherwise.
“We don’t have the drug just generally available,” Ranney says.
Remdesivir, an antiviral treatment for COVID-19, was also initially available in very limited quantities. The Utah Department of Health is using its process for distributing that drug — which was based in part on patients’ symptoms — as a template for the antibody therapy. The health department is now convening its scarce resources committee to work through the bamlanivimab issues. The Connecticut Department of Public Health is also using a similar system to the one it used for remdesivir, which allocated the drug to different hospitals based on the types of patients it was treating and the clinical expertise of the doctors working there, a spokesperson told The Verge.
However, bamlanivimab is more complicated than remdesivir, both health departments noted. The drug is for people who aren’t yet sick enough to be hospitalized. “The idea behind it is that it’ll be for patients who are early in the course of the disease, and are at a very high risk of needing to be hospitalized,” Ranney says, for example, older patients. But it has to be given to those patients within 10 days of when their symptoms start — so they have to get tested and get their results back before those 10 days are up.
Timing, then, is everything. Right now, testing often doesn’t happen fast enough to catch people in that window, Ranney says.
In addition, even if a high-risk patient tests positive in enough time to get the antibody treatment, there’s a good chance that there might not be a dose available for them. By the time another batch comes in, 10 days could have already passed since they started having symptoms, Gellad says. “By the time you get to the next week, you’re out of the window when you could benefit,” he says. “I assume that’s going to happen to a lot of people.”
Figuring out where to give eligible patients the treatment is another challenge. Bamlanivimab is delivered in an hour-long infusion, and many sites where IV treatments are given aren’t easy to set up for COVID-19 patients. They’re usually used for things like chemotherapy or other immunosuppressive drugs, and they treat people who are especially vulnerable to the coronavirus. “You can’t just send COVID-19 patients to the same places people are getting chemo,” Gellad says.
Eli Lilly and the other pharmaceutical companies developing antibody treatments are working to scale up production of the drugs. Eli Lilly said it aims to produce 1 million doses this year. Some of the other challenges — identifying patients who will benefit most from the drug, figuring out where the best places are to give infusions — are solvable, Gellad says. But health systems may not have the bandwidth to solve them at the same time that they’re fighting an overwhelming surge of COVID-19 cases. “The question is, are they solved now?” he says. “Or, when the current wave is over, and most of the people that could benefit have already gotten COVID-19?”
Via The Verge Science