FDA Zepbound shortage ends, impacts patients, compounding pharmacies

The roughly $1,000 monthly price tag of Eli Lilly‘s weight reduction drug Zepbound put the blockbuster treatment out of reach for Willow Baillies, 29, whose insurance doesn’t cover it.

Baillies, a human resources specialist based in Milwaukee, Wisconsin, has been attempting to shed pounds and coping with chronic autoimmune issues for years, so she turned to a less expensive alternative: a compounded, off-brand version of tirzepatide.

Tirzepatide is the lively ingredient in Zepbound and in Eli Lilly’s diabetes counterpart Mounjaro, that are a part of a category 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 kilos. She said it costs her around $350 monthly.

But soon, compounded versions of tirzepatide could develop into inaccessible to Baillies and other patients who depend on them. Patients and health-care experts said that might force some consumers to stockpile doses, switch to other treatments, or stop receiving care altogether resulting from financial constraints. Others could turn to a potentially unsafe approach to mixing vials themselves. 

That is since the Food and Drug Administration on Thursday announced that branded tirzepatide is not any longer in brief supply — a choice that may largely prevent compounding pharmacies from making and selling cheaper versions of the drug in the following two to 3 months. 

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But drugmakers and a few health experts have pushed back against the practice since the FDA doesn’t approve compounded drugs, that are essentially custom-made copies prescribed by a health care provider to fulfill a particular patient’s needs. 

The FDA’s decision, based on the agency’s comprehensive evaluation of knowledge, could mean that more patients with insurance coverage will give you the option 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 beginning to repay. 

But it’s going to also leave other patients in limbo, closing a distinct segment, lucrative marketplace for compounded tirzepatide that patients say helped fill a niche in care for individuals who cannot afford to pay out of pocket for Zepbound.

Many insurance coverage still don’t cover drugs for weight reduction, and a few 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 even have no less than a yr’s price,” said Baillies, considered one of six patients CNBC spoke with about compounded tirzepatide. “We’re willing to sort of do anything to have this. It is not nearly looks; it’s in regards to the opportunity it gives us to live our lives to the fullest.” 

Many patients and major trade groups query whether the shortage is actually resolved amid reports of individuals still struggling to search out Eli Lilly’s drugs. 

Some medical professionals raised concerns about whether Eli Lilly can meet demand over again patients come off compounded tirzepatide and others start Zepbound for its newly approved use: obstructive sleep apnea. 

It’s unclear what number of persons are on compounded tirzepatide, but one trade group estimated in November that there are greater than 200,000 prescriptions for compounded versions of its principal rival — Novo Nordisk‘s weight-loss drug Wegovy — being filled every month. 

“On this current moment, I trust that the shortage is over,” said Dr. Shauna Levy, an obesity medicine specialist and medical director of the Tulane Bariatric Center in Recent Orleans. “Do I believe the shortage is over eternally? Probably not.” 

In an announcement on Friday, Eli Lilly said the FDA’s decision “reflects the tireless work of our manufacturing and quality colleagues to securely expand our manufacturing capability to bring these medicines to individuals who need them.” The corporate added that anyone marketing or selling “unapproved tirzepatide knockoffs must stop.”

The FDA initially declared the tirzepatide shortage over in October. 

But a trade group called the Outsourcing Facilities Association sued days later, claiming the agency made its determination without proper notice and did not account for continued supply disruptions. That lawsuit pushed the FDA to reconsider and allowed pharmacists to make compounded versions within 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 greatest judgment, it’s going to meet or exceed projected demand.”

The FDA is giving so-called 503A compounding pharmacies until Feb. 18 before it takes enforcement motion that may put a halt to their work. The 503A pharmacies make compounded drugs based on individual prescriptions for a particular patient and are largely regulated by states relatively than the FDA. 

Meanwhile, pharmacies manufacturing compounded drugs in bulk with or without prescriptions — often called 503B outsourcing facilities — get an extra month, with a deadline of March 19. They’re regulated by FDA guidelines. 

Those “off-ramp periods are appreciated” since it gives patients time to change to brand-name tirzepatide, said Tenille Davis, chief advocacy officer for trade group Alliance for Pharmacy Compounding.

However the group’s members are still reporting that “there is 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 could also be allowed to proceed making compounded tirzepatide in certain situations under the law, Davis said. 

That features when a prescriber determines that a compounded version with certain changes will produce a “significant difference” for a patient. For instance, a patient may have a specialized dose or be allergic to the dye in a branded product. 

Davis said meaning compounded tirzepatide won’t be completely eliminated within the U.S., but the dimensions of it’s going to “actually decrease.”

The legal battle between the FDA and the Outsourcing Facilities Association is not over yet, nevertheless. On Thursday, the FDA and OFA jointly said they are going to provide an update in court by Jan. 2 to deal with the “next steps on this litigation.” Additionally they said if the trade group files a preliminary injunction over the following two weeks, the FDA is not going to take motion 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 within the dispute with the FDA.

Many patients who depend on compounded tirzepatide are scrambling to make sure they’ll proceed care. 

That features Amanda Bonello, 36, an Iowa-based account manager who said she is prediabetic. Bonello said taking compounded tirzepatide over the past two months has helped her lose 26 kilos and normalized her blood sugar levels, allowing her to avoid a diabetes diagnosis. 

“If compounded semaglutide goes away as well, then I shall be screwed,” Bonello said. She has launched an online petition demanding that the FDA support access to compounded GLP-1s. The petition has gained greater than 15,000 signatures up to now month.

One other patient, Erin Hunt, 31, a communications analyst based in Maryland, said she may eventually switch to the branded version of tirzepatide. 

Hunt began taking compounded tirzepatide in April after struggling to search out supply of Zepbound, which she took for one month. It has helped her lose around 55 kilos, experience fewer symptoms from her chronic inflammatory conditions and pursue a healthier food regimen and exercise. She said she initially paid $300 monthly for the compound drug and now pays $350 for the next dose.

Hunt’s insurance doesn’t cover Zepbound. But she qualifies for Eli Lilly’s savings card program, which allows commercially insured patients without coverage for Zepbound to purchase a month’s supply for around $650. Under that program, patients whose industrial insurance plan covers Zepbound pays as little as $25. 

“I’m extremely concerned for what it is going to cost,” Hunt said. “This medication has literally modified my life, and it’s probably going to learn me to be on a maintenance dose for all times.”

For Jill Skala, 49, a teacher in western Pennsylvania, the FDA’s decision signifies that she’s going to lose a cheaper option after her insurance drops Zepbound coverage on Jan. 1. 

Her copay for Zepbound has been around $10 monthly since she began the drug in March. Skala said she has lost 52 kilos and noticed “profound improvements” in her mental health, sleep and energy levels. She has stockpiled a three-month supply of Zepbound, she said, and can “do the perfect I can to take care of my weight reduction” once that runs out.

“I do not see myself continuing to get the branded version at this point unless there is a pathway back through insurance or Eli Lilly drops the worth,” Skala said. “I just paid off my student loans. I don’t desire to begin my medical debt problem here.”

Other patients may turn to an underground community Reddit users call “the grey market”: People directly purchase powdered tirzepatide or semaglutide peptides for as little as $50 monthly from certain vendors, including Chinese manufacturers, and blend that with sterile water at home, creating an answer they’ll inject under their skin. 

Reddit users say the community establishes protocols for third-party lab testing of peptides to confirm their purity and promotes secure mixing and dosing practices. 

But Tulane’s Levy said the tactic “seems very dangerous,” noting that mixing homemade medications without proper training “could potentially have real consequences.” 

She said it “highlights people’s desperation to treat the disease of obesity, which is being inadequately met by our current insurance status” for drugs equivalent to Zepbound. 

Some compounding pharmacies equivalent to Strive Pharmacy are operating as usual pending more updates to the legal fight. Strive operates nine 503A pharmacies across the U.S., which supply compounded GLP-1s and other services. 

But Strive will largely stop making compounded tirzepatide by the February deadline if nothing further happens, based on Matthew Montes de Oca, the corporate’s chief clinical officer. He acknowledged that Strive could create compounded versions of the drug for specific prescriptions, equivalent to adding glycine to assist prevent muscle deterioration in a patient. 

Compounded tirzepatide with glycine is what Gina Wright’s doctor will prescribe for her so she will proceed taking the unbranded version, which she gets from a special pharmacy. Wright, 58, a self-employed business consultant in Colorado who’s prediabetic, said she is paying $225 for a five-milligram dose, which she began taking earlier this month. 

She is on her state Medicaid plan, which doesn’t cover Zepbound, so she doesn’t qualify for Eli Lilly’s savings card program. But Wright said she also has sleep apnea, so she is attempting to get insurance to cover Zepbound for that purpose.

De Oca said compounding individual injectable GLP-1 prescriptions for specific patients will make it harder for Strive to be sure that all of its safety procedures equivalent to stability studies are still in place. Strive typically tests its tirzepatide and semaglutide with a third-party analytical company and conducts a months-long “stability study” to ensure the standard and safety of the product before creating batches of as much as 250 vials, he noted. 

Dr. Mace Scott, the owner and medical director of Chronos Body Health Wellness, said the fate of compounded tirzepatide at his Louisiana-based medical spa will rely upon the pharmacies he sources it from and “how they determine to maneuver forward.” His spa relies on each 503A and 503B pharmacies, he said, so some patients may give you the option to proceed compounded tirzepatide with a specialized prescription. 

Scott said he’s attempting to help some patients get insurance approval for branded tirzepatide. He’s recommending that others switch to compounded semaglutide, which is what roughly 75% of Chronos patients are taking, he said. The spa has treated greater than 10,000 patients with branded or compounded GLP-1 medications, based on its website.

“It’s sort of a troublesome road to traverse without delay, so we’re attempting to work out what’s best on a patient-by-patient basis,” Scott told CNBC. 

The American Diabetes Association, a nonprofit organization that promotes diabetes research and advocacy, told CNBC it recommends against the usage of compounded GLP-1s resulting from “ongoing concerns” about their safety, quality and efficacy.

It’s difficult to discern the standard of the product and its distributor, which poses a possible risk to patients, Joshua Neumiller, the association’s president-elect for health care and education, said in an announcement.

Neumiller also pointed to an FDA alert in July about cases of patients measuring and administering incorrect doses of compounded GLP-1s, a few of which resulted in hostile events that required hospitalization. 

But Molly B., an interior designer based in Recent York who asked CNBC to omit her full last name, said compounded GLP-1s are her only option.

She said her insurance denied coverage for brand-name semaglutide twice before she began taking compounded tirzepatide in September. It has helped her lose 23 kilos, she said, and eliminated constant thoughts about food — a game changer for a patient affected by polycystic ovary syndrome, a hormonal disorder that makes it difficult to shed pounds. 

“I even have never been capable of lose this much weight alone, and I’ve tried 100 times,” she said. “This has really modified my life, so I might hope that I can proceed to get it the way in which I’m now.”