Eli Lilly has struck a deal with the federal government to provide 300,000 doses of a drug that's designed to keep people infected with COVID-19 out of the hospital. The cost per dose: $1,250.
The federal government plans to distribute the 300,000 doses at no cost, but that doesn't mean treatment will be free.
The Lilly drug, a type of monoclonal antibody, is given by intravenous infusion. Those infusions, typically given in hospitals or standalone clinics, can cost well over $1,000. People with health insurance are often required to pay hundreds of dollars in copayments.
"Our goal is zero out-of-pocket expenses, wherever possible, for any patient receiving a Lilly COVID-19 antibody treatment," said CEO Dave Ricks. However, his statement acknowledged that "health care facilities may charge a fee for the product's administration."
The Food and Drug Administration is considering whether to grant emergency use authorization for this drug, along with a similar product developed by Regeneron. The Lilly deal is contingent on the FDA clearing the medicine for emergency use.
President Trump received the Regeneron treatment shortly after he was diagnosed with COVID-19. He has told Americans they, too, would get it at little or no out-of-pocket cost. However, the federal government has not addressed the issue of infusion costs.
The Lilly drug was tested on people who had been infected with the coronavirus but weren't sick enough to go to the hospital. As outlined in a paper published online Wednesday by the New England Journal of Medicine, 1.6% of people who got the drug ended up in the hospital or at the emergency room, compared with 6.3% of people who got the placebo.
That translates to $125,000 in upfront drug costs to prevent five trips to the emergency room or hospital, or $25,000 a piece. But adding in infusion costs could double the expense.
Since only a small percentage of people who are infected with the coronavirus require hospitalization, taking a drug to reduce that risk would be a judgment call. Is it worthwhile to go to the emergency room for an infusion, and possibly face a substantial copayment, in order to reduce the risk of having to go back to the hospital later with COVID-19?
"A lot of people are already reluctant to get infusions of antibodies," Dr. Scott Gottlieb, former FDA commissioner, said Tuesday on a webcast. Compared with pills, he said, "people inherently look at an infusion as more invasive, as potentially more risky."
Ultimately drug companies hope to make antibodies available as injections rather than infusions, but the first-generation products need to be given in large quantities, so they require infusions.
One decision the FDA will need to make is about the proper dosage. The study reported in the New England Journal of Medicine found that the dose that appeared most effective required 2,800 milligrams of the drug. However, Lilly is arguing that 700 milligrams would be sufficient – in fact, that's the dosage that it has sold to the federal government.
Lilly says it has requested that the drug be made available specifically to those at higher risk – older Americans and people with obesity. Its study in the New England Journal of Medicine shows greater benefit for that at-risk group: 4% of the people in that group ended up in the hospital, compared with 15% of people over 65 or with obesity in the placebo group. However, the study was not designed to look at this subgroup, so this could be a statistical fluke.
That at-risk group still represents a large population. In August alone, the Centers for Disease Control and Prevention reported more than 164,000 cases of coronavirus in Americans over 60. Obesity affects 40% of US adults, so that could translate into another 300,000 people a month potentially eligible for this treatment. So, the 300,000 doses the government has purchased could be used up quickly if demand is high. Lilly hopes to produce up to a million doses by the end of 2020, and intends to make it available worldwide.
Supplies could last longer if the FDA also grants emergency access to the Regeneron antibodies. That product is a combination of two antibodies. The company says its treatment is most effective in people who have been infected but who have not yet developed their own antibodies (those usually appear in the blood about a week after infection). If the FDA restricts the use of that product to people who have tested negative for coronavirus antibodies, the two products could target somewhat different populations.
The federal government announced in July it would purchase up to 300,000 doses of the Regeneron antibodies.
Late Wednesday, Regeneron announced it has submitted more data to the FDA, bolstering its case that the company's monoclonal antibodies reduce the amount of virus in patients.
"These viral reductions are associated with a significant decrease in the need for further medical attention and lessen the need for medical care," Dr. George Yancopoulos, the company's president and CEO, said in a statement.
You can contact Richard Harris at firstname.lastname@example.org.
DAVID GREENE, HOST:
The Food and Drug Administration has given its thumbs up to a drug that's designed to prevent people with mild to moderate COVID-19 from getting sicker. This drug will be available to people over 65 or with underlying health conditions. The FDA has not fully approved it, but it has authorized it for emergency use. NPR science correspondent Richard Harris is here to talk about this. Good morning.
RICHARD HARRIS, BYLINE: Good morning, David.
GREENE: So tell me more about this drug.
HARRIS: Well, it's called a monoclonal antibody. And this one is made by Eli Lilly. President Trump got a similar medication from a company called Regeneron, but that product is still under review at the FDA. Now, these are synthetic antibodies that block the virus and prevent it from infecting cells. And the idea is to give people who have mild to moderate illness but aren't sick enough to be in the hospital, keep them out of the hospital, and that's really the goal of this drug.
GREENE: And does it seem to work pretty reliably?
HARRIS: Well, here's the thing - most people with mild to moderate COVID never end up in the hospital, so most people won't actually benefit from this in an obvious way. The FDA wants to restrict it to people who have a higher risk, like a 10% chance of needing hospitalization. And in that population, they figure the hospitalization rate would drop to about 3%. So looked at another way, if you give this to 100 people, it could theoretically prevent seven hospitalizations. So, basically, improves the odds a bit.
GREENE: But if you think you might be eligible, I mean, is this something you would get from your doctor? Or how would you get access to it?
HARRIS: That's one of the big challenges of this drug because it needs to be given by IV infusion, and that isn't simple. Dr. Walid Gellad at the University of Pittsburgh predicts that it's going to be chaotic figuring out how to administer the drug.
WALID GELLAD: We don't want people running to the emergency room to get this therapy. We don't want people running to infusion centers, where there are patients with cancer. And we don't want them running necessarily to their primary care doctor's office that are not set up for these infusions. It is not clear at all where the infusions are going to happen.
HARRIS: Maybe hospitals will set up tents. But in any event, he says it raises all sorts of questions about fair and equitable access to this drug.
GREENE: I mean, at a moment when we're seeing, you know, record-high new cases in this country, which begs the question - I mean, could we reach a point where there's just not enough of this drug to go around?
HARRIS: Well, there clearly won't be enough, at least not in the short run. Eli Lilly says it hopes to have a million doses by the end of the year, which sounds impressive, but considering that every day there are tens of thousands of new coronavirus cases in the United States, even that big-sounding supply really won't stretch. So that could be one reason the FDA has decided to limit its use to people at highest risk - those people over 65 and with underlying health conditions, including obesity.
The federal government has agreed to purchase 300,000 doses and distribute them to the states. And the drug costs more than $1,200 per dose, so it's a relief that the government has at least picked up the tab, at least for that initial supply.
GREENE: So during his campaign, President Trump promised seniors that they would get access to these kinds of antibodies at little or no cost, just like he was able to. You mentioned that he got something like this. Will that be the case here?
HARRIS: Well, even though the drug itself will be free, the treatment won't be. I talked to health care economists, who figured out the cost to seniors could end up somewhere between $50 and $300 per treatment, depending upon the Medicare plan and whether a person has reached the annual deductible and so on. Medicare says hospitals can volunteer to waive their fees, but that's unlikely to happen. Commercial insurers, on the other hand, have been providing coronavirus treatments at no cost, so we'll see if that extends to the monoclonal antibodies. And the uninsured could face hefty bills here.
GREENE: So big picture, Richard, how does this fit into the larger sort of picture of coronavirus treatment?
HARRIS: Yeah, there is an antiviral drug called remdesivir, which is given to hospitalized patients, and studies shows that it shortens hospital stays, but it hasn't been proven to save lives. Another drug, dexamethasone, is a lifesaver and is used in patients who are seriously ill. The monoclonal antibodies fill a different niche, basically keeping people out of the hospital. Of course, you may recall that strategy didn't work for Trump...
HARRIS: ...Who ended up in the hospital anyway after his treatment with monoclonal antibodies.
GREENE: All right. NPR science correspondent Richard Harris. Richard, thanks as always.
HARRIS: Pleasure to be with you. Transcript provided by NPR, Copyright NPR.