The FDA has declared an finish to the scarcity of a preferred weight problems drug. The implications for customers are sophisticated.
SCOTT SIMON, HOST:
The drug Zepbound won’t have the identical title recognition as Ozempic, however it’s one other within the class to deal with weight problems and Kind 2 diabetes. And like Ozempic and Wegovy, Zepbound has been in brief provide due to excessive demand. The Meals and Drug Administration declared it resolved final week. NPR prescription drugs correspondent Sydney Lupkin joins us. Sydney, thanks a lot for being with us.
SYDNEY LUPKIN, BYLINE: Yeah. Hello, Scott.
SIMON: However I collect the ending of a drug scarcity is eliciting blended emotions.
LUPKIN: Yeah. And, you realize, in most circumstances, it will be celebrated throughout. However on this case, many individuals will find yourself spending extra to handle their weight problems. Here is what’s occurring. Tirzepatide is the lively ingredient in Eli Lilly’s Zepbound for weight problems and Mounjaro for diabetes. Specialised pharmacies, known as compounding pharmacies, have been legally allowed to make what are primarily copies of tirzepatide, as a result of the brand-name medication had been in scarcity. And the compounded variations of the medicines had been lots cheaper. A number of hundred greenback a month for sufferers in contrast $1,000 or extra for the brand-name medication.
SIMON: That is an enormous distinction.
LUPKIN: Yeah. So the stakes are excessive. In October, FDA first stated the scarcity was over, however a commerce group for the most important compounding pharmacies sued the FDA, difficult that dedication. The compounders stated there was no manner the scarcity might be over, as a result of many sufferers nonetheless could not fill their name-brand prescriptions, they usually alleged that the FDA hadn’t decided how many individuals would want to make the swap from the compounded to the name-brand medication both. So the FDA took one other look and for a second time, declared the tirzepatide scarcity resolved.
SIMON: Why does the FDA suppose the scarcity is over this time?
LUPKIN: The company says it took a take a look at many components, together with the drug producer’s stock information, projected demand. It says it additionally spoke to sufferers, well being care suppliers and compounding pharmacies. Backside line, the company stated it thinks Eli Lilly could make sufficient. Lilly stated in a press release that the FDA choice displays the corporate’s exhausting work to increase its manufacturing capability and meet affected person wants. So compounding pharmacies might want to cease making and promoting the compounded variations in February or March, relying on their measurement.
SIMON: However, Sydney, aren’t lots of people taking compounded weight problems medication already?
LUPKIN: Sure, although the precise quantity is tough to pin down. I’ve heard from a number of sufferers who take into account them a lifeline. And that is as a result of many well being insurers will not cowl the medication for weight reduction. Medicare, as an example, is banned from protecting medication for weight reduction due to an outdated regulation written at a time when having weight problems was thought of extra of a private failure than a well being situation. Meaning folks with out protection should pay the complete sticker value for the name-brand medication, and that is unaffordable for lots of people who’ve turned to the cheaper, compounded variations of the medication.
SIMON: What are these sufferers going to do?
LUPKIN: Some are stockpiling the compounded medication, you realize, whereas they’ll. I checked in with Mary Striewski, an Arizona girl, who instructed me just a few weeks in the past about how she misplaced 50 kilos up to now on compounded tirzepatide. She says she and her nurse practitioner settled on a plan to purchase sufficient tirzepatide to get her by till about April. And after that, she is not positive. However she says she must discover a strategy to hold taking the drugs.
MARY STRIEWSKI: I am a modified particular person. And it is primarily as a result of it has modified me essentially in the best way I’m going about life every single day.
LUPKIN: Her well being is best, and she or he says she’s freed from the nervousness that got here with consuming. She’s enthusiastic about what she needs to perform in 2025.
SIMON: May insurance coverage protection for the name-brand Zepbound get higher now that the compounded variations are off the desk?
LUPKIN: You already know, it might, as a result of the FDA simply accepted Zepbound as the primary drug therapy for average to extreme obstructive sleep apnea in sufferers who’ve weight problems. Obstructive sleep apnea is a situation during which somebody briefly pauses respiration of their sleep as a result of their higher airway collapses. It’s extra frequent amongst individuals who have weight problems. The brand new approval might open the door for Zepbound protection by Medicare and Medicaid as a result of it isn’t only a weight reduction drug anymore. So whereas that is not going to unravel everybody’s insurance coverage issues right here, it might assist lots of people.
SIMON: NPR prescription drugs correspondent Sydney Lupkin. Thanks a lot.
LUPKIN: You wager.
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