SCOTT SIMON, HOST:
The drug Zepbound might not have the same name recognition as Ozempic, but it's another in the class to treat obesity and Type 2 diabetes. And like Ozempic and Wegovy, Zepbound has been in short supply because of high demand. The Food and Drug Administration declared it resolved last week. NPR pharmaceuticals correspondent Sydney Lupkin joins us. Sydney, thanks so much for being with us.
SYDNEY LUPKIN, BYLINE: Yeah. Hi, Scott.
SIMON: But I gather the ending of a drug shortage is eliciting mixed feelings.
LUPKIN: Yeah. And, you know, in most circumstances, it would be celebrated all around. But in this case, many people will end up spending more to manage their obesity. Here's what's happening. Tirzepatide is the active ingredient in Eli Lilly's Zepbound for obesity and Mounjaro for diabetes. Specialized pharmacies, called compounding pharmacies, have been legally allowed to make what are essentially copies of tirzepatide, because the brand-name drugs were in shortage. And the compounded versions of the medicines were a lot cheaper. A few hundred dollar a month for patients compared $1,000 or more for the brand-name drugs.
SIMON: That's a big difference.
LUPKIN: Yeah. So the stakes are high. In October, FDA first said the shortage was over, but a trade group for the largest compounding pharmacies sued the FDA, challenging that determination. The compounders said there was no way the shortage could be over, because many patients still couldn't fill their name-brand prescriptions, and they alleged that the FDA hadn't determined how many people would need to make the switch from the compounded to the name-brand drugs either. So the FDA took another look and for a second time, declared the tirzepatide shortage resolved.
SIMON: Why does the FDA think the shortage is over this time?
LUPKIN: The agency says it took a look at many factors, including the drug manufacturer's inventory data, projected demand. It says it also spoke to patients, health care providers and compounding pharmacies. Bottom line, the agency said it thinks Eli Lilly can make enough. Lilly said in a statement that the FDA decision reflects the company's hard work to expand its manufacturing capacity and meet patient needs. So compounding pharmacies will need to stop making and selling the compounded versions in February or March, depending on their size.
SIMON: But, Sydney, aren't a lot of people taking compounded obesity drugs already?
LUPKIN: Yes, though the exact number is hard to pin down. I've heard from lots of patients who consider them a lifeline. And that's because many health insurers won't cover the drugs for weight loss. Medicare, for instance, is banned from covering drugs for weight loss because of an old law written at a time when having obesity was considered more of a personal failure than a health condition. That means people without coverage will have to pay the full sticker price for the name-brand drugs, and that's unaffordable for a lot of people who've turned to the cheaper, compounded versions of the drugs.
SIMON: What are those patients going to do?
LUPKIN: Some are stockpiling the compounded drugs, you know, while they can. I checked in with Mary Striewski, an Arizona woman, who told me a few weeks ago about how she lost 50 pounds so far on compounded tirzepatide. She says she and her nurse practitioner settled on a plan to buy enough tirzepatide to get her through until about April. And after that, she isn't sure. But she says she needs to find a way to keep taking the medicine.
MARY STRIEWSKI: I'm a changed person. And it's primarily because it has changed me fundamentally in the way I go about life every day.
LUPKIN: Her health is better, and she says she's free of the anxiety that came with eating. She's thinking about what she wants to accomplish in 2025.
SIMON: Could insurance coverage for the name-brand Zepbound get better now that the compounded versions are off the table?
LUPKIN: You know, it could, because the FDA just approved Zepbound as the first drug treatment for moderate to severe obstructive sleep apnea in patients who have obesity. Obstructive sleep apnea is a condition in which someone temporarily pauses breathing in their sleep because their upper airway collapses. It is more common among people who have obesity. The new approval could open the door for Zepbound coverage by Medicare and Medicaid because it's not just a weight loss drug anymore. So while that's not going to solve everyone's insurance problems here, it could help a lot of people.
SIMON: NPR pharmaceuticals correspondent Sydney Lupkin. Thanks so much.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.
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