An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City on Dec. 11, 2023.
Brendan McDermid | Reuters
The roughly $1,000 monthly price tag of Eli Lilly‘s weight loss drug Zepbound put the blockbuster treatment out of reach for Willow Baillies, 29, whose insurance does not cover it.
Baillies, a human resources specialist based in Milwaukee, Wisconsin, has been attempting to lose weight and dealing with chronic autoimmune issues for years, so she turned to a cheaper alternative: a compounded, off-brand version of tirzepatide.
Tirzepatide is the active ingredient in Zepbound and in Eli Lilly’s diabetes counterpart Mounjaro, which are part of a class of highly popular medications called GLP-1s.
She said compounded tirzepatide has helped change her life dramatically since she began taking it in June, alleviating pain from her autoimmune issues and helping her lose about 52 pounds. She said it costs her around $350 per month.
But soon, compounded versions of tirzepatide could become inaccessible to Baillies and other patients who rely on them. Patients and health-care experts said that could force some consumers to stockpile doses, switch to other treatments, or stop receiving care altogether due to financial constraints. Others could turn to a potentially unsafe method of mixing vials themselves.
That’s because the Food and Drug Administration on Thursday announced that branded tirzepatide is no longer in short supply — a decision that will largely prevent compounding pharmacies from making and selling cheaper versions of the drug in the next two to three months.
During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient’s needs.
The FDA’s decision, based on the agency’s comprehensive analysis of data, could mean that more patients with insurance coverage will be able to access Zepbound after months of limited supply. It also suggests that Eli Lilly’s multibillion-dollar effort to ramp up manufacturing for tirzepatide is starting to pay off.
But it will also leave other patients in limbo, closing a niche, lucrative market for compounded tirzepatide that patients say helped fill a gap in care for those who can’t afford to pay out of pocket for Zepbound.
Many insurance plans still don’t cover drugs for weight loss, and some patients said prices under Eli Lilly’s savings program and for its half-priced vial versions are still too high.
“I’ve stockpiled 10 compounded vials at home, so I have at least a year’s worth,” said Baillies, one of six patients CNBC spoke with about compounded tirzepatide. “We’re willing to kind of do anything to have this. It’s not just about looks; it’s about the opportunity it gives us to live our lives to the fullest.”
Many patients and major trade groups question whether the shortage is truly resolved amid reports of people still struggling to find Eli Lilly’s drugs.
Some medical professionals raised concerns about whether Eli Lilly can meet demand once more patients come off compounded tirzepatide and others start Zepbound for its newly approved use: obstructive sleep apnea.
It’s unclear how many people are on compounded tirzepatide, but one trade group estimated in November that there are more than 200,000 prescriptions for compounded versions of its main rival — Novo Nordisk‘s weight-loss drug Wegovy — being filled each month.
“In this current moment, I have confidence that the shortage is over,” said Dr. Shauna Levy, an obesity medicine specialist and medical director of the Tulane Bariatric Center in New Orleans. “Do I think the shortage is over forever? Probably not.”
Eli Lilly did not immediately respond to a request for comment.
sued days later, claiming the agency made its determination without proper notice and failed to account for continued supply disruptions. That lawsuit pushed the FDA to reconsider and allowed pharmacists to make compounded versions in the meantime.
In its decision announced Thursday, the FDA concluded based on data from Eli Lilly, patients, providers, compounders, and other sources that “Lilly’s supply is currently meeting or exceeding demand and that, based on our best judgment, it will meet or exceed projected demand.”
The FDA is giving so-called 503A compounding pharmacies until Feb. 18 before it takes enforcement action that would put a halt to their work. The 503A pharmacies make compounded drugs according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.
Meanwhile, pharmacies manufacturing compounded drugs in bulk with or without prescriptions — known as 503B outsourcing facilities — get an additional month, with a deadline of March 19. They are regulated by FDA guidelines.
An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York on March 28, 2024.
Shelby Knowles | Bloomberg | Getty Images
Those “off-ramp periods are appreciated” because it gives patients time to switch to brand-name tirzepatide, said Tenille Davis, chief advocacy officer for trade group Alliance for Pharmacy Compounding.
But the group’s members are still reporting that “there’s a real lack of availability” of tirzepatide, she said. That trade group represents compounding pharmacies and hybrid pharmacies that also dispense regular drug prescriptions.
Still, 503A pharmacies may be allowed to continue making compounded tirzepatide in certain situations under the law, Davis said.
That includes when a prescriber determines that a compounded version with certain changes will produce a “significant difference” for a patient. For example, a patient may need a specialized dose or be allergic to the dye in a branded product.
Davis said that means compounded tirzepatide won’t be completely eliminated in the U.S., but the scale of it will “certainly decrease.”
The legal battle between the FDA and the Outsourcing Facilities Association isn’t over yet, however. On Thursday, the FDA and OFA jointly said they will provide an update in court by Jan. 2 to address the “next steps in this litigation.” They also said if the trade group files a preliminary injunction over the next two weeks, the FDA will not take action against its members for continuing to make compounded tirzepatide until the court resolves the case.
That pending litigation further “adds to the confusion of the status of compounded tirzepatide after February and March,” said Dae Lee, a partner at law firm Frier Levitt who represents pharmacies, none of which were involved in the dispute with the FDA.
normalized her blood sugar levels, allowing her to avoid a diabetes diagnosis.
She said she “absolutely cannot” afford branded tirzepatide since her insurance does not cover it, so she will consider switching to compounded semaglutide. That is the active ingredient in Wegovy and its diabetes counterpart Ozempic, Novo Nordisk’s two GLP-1s that are still on the FDA’s drug shortage list.
Many compounding pharmacies make unbranded versions of semaglutide, which has been on the U.S. market — and in short supply — for much longer than tirzepatide. But an end to the shortage may be imminent, with the FDA announcing in late October that all doses of semaglutide are available.
“If compounded semaglutide goes away as well, then I will be screwed,” Bonello said. She has launched an online petition demanding that the FDA support access to compounded GLP-1s. The petition has gained more than 15,000 signatures in the past month.
