As Eli Lilly, compounders battle over weight loss drugs, patients are caught in the middle

At issue is easy and affordable access to medications

Glass vials

By Elaine Chen

Oct. 11, 2024

National Biotech Reporter

There’s a war brewing over blockbuster weight loss medications — and patients are now getting caught in the crossfire.

Last week, the Food and Drug Administration declared an end to the shortage of Eli Lilly’s tirzepatide, sold under the brand name Mounjaro for diabetes and Zepbound for obesity. The move was a clear warning to compounders that they can no longer make copycat versions of the drugs — a process that is only permitted when the medications are on an official agency shortage list.

On Thursday, Lilly, which has long warned about the risks of knockoff products, also ramped up its fight against compounders, sending hundreds of cease-and-desist letters telling them and telehealth platforms to stop making their versions.

At the same time, despite the FDA’s declaration, pharmacies are still having trouble getting Lilly’s treatment in stock. And even if they had supplies, many patients still can’t afford the branded drugs, which carry a list price of over $1,000 a month and are not widely covered by insurers. Lilly last month introduced what it called discounted vials of Zepbound, but they’re only offered at the lowest doses and some patients say they’re still too expensive.

“There’s a whole cohort of individuals who are finding success in using compounded tirzepatide to treat obesity, and those are the individuals who are at highest risk of losing those health benefits with the end of this shortage and the enforcement of the patent form of the medication,” said Beverly Tchang, an obesity medicine doctor at Weill Cornell Medicine. Tchang has not personally prescribed compounded products, but she’s an adviser for Ro, a telehealth platform that does.

Many patients, Tchang and other experts said, now face a near-impossible situation, with their access to both compounded and branded versions uncertain.

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That could bring health risks if patients suddenly stop taking tirzepatide because they run out. Not only could they regain weight, but they could also see the return of conditions that had been addressed by the treatment — such as high blood pressure or blood sugar. Some research also suggests that weight cycling, the process of losing and then regaining weight, can in itself introduce health risks.

Experts also fear some patients may turn to dangerous alternatives. On online forums, users have indicated they may start stockpiling and rationing compounded supplies, which could present health risks if they use the treatments past their expiration dates. Some users have said that they plan to lose as much weight as they can before they run out of the drugs, but jumping to higher doses too quickly could lead to more severe vomiting and other gastrointestinal side effects than they would otherwise experience on the treatments.

Meanwhile, counterfeit drugs and what some websites have advertised as “research chemicals” that are not regulated, present further risk.

For now, the compounding of semaglutide, the scientific name of Novo Nordisk’s Ozempic and Wegovy, is still permitted, as the branded versions are still on the FDA shortage list. Some patients who have been using tirzepatide may be directed to use that drug instead. But it would take time for patients to get a new prescription, and semaglutide is not as potent as tirzepatide.

And as the current situation foreshadows, semaglutide could come off the shortage list at any time, leaving patients with even fewer options.

“A lot of people don’t understand how temporary those compounding allowances are,” said Erin Fox, a pharmacist at University of Utah who tracks drug shortages. “It seems like people really started to rely on those products that were never — they were always kind of doomed.”

Supply of branded drugs still uncertain

Even though the FDA said the tirzepatide shortage has been resolved, pharmacies around the country say it’s still difficult to get ahold of the treatment. A drug shortage database managed by the University of Utah Drug Information Service still lists the medication in shortage, since it continues to get reports from pharmacies and patients, Fox said.

Mark Boesen, founding partner of law firm Boesen & Snow, which represents compounders and traditional pharmacies, said that a pharmacy in Utah he represents tried to order several hundred doses of the branded product recently. But the pharmacy’s wholesaler, Cardinal Health, told them it would take six months to supply them that amount.

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As of late Wednesday, the Cardinal distribution center with which the Utah pharmacy places its orders had in stock only a range of 29 to 67 boxes for each dose of Zepbound and a range of 88 to 308 boxes for each dose of Mounjaro, according to Boesen. One box contains just one patient’s one-month supply, and the distribution center covers pharmacies across multiple states — Utah, Nevada, Idaho, and Wyoming, Boesen said.

In Arizona, where Boesen is based, pharmacies are not allowed to order more than two boxes a day and more than 12 boxes a week. One of Boesen’s clients in the state orders from the distributor McKesson, which still has one of the higher doses of Mounjaro on backorder, he said.

For Boesen, it’s also a personal issue. He himself takes Zepbound, and over the past few months, he was able to get it since he knows all the local pharmacists. But he said that, ever since last week, when the FDA said the shortage was resolved, none of the pharmacies he called has been able to get the drug for him.

Boesen started taking Mounjaro in 2022, before Zepbound was approved. He had a body mass index of 46 and had pre-diabetes, sleep issues, and intense knee pain. After starting Mounjaro and then eventually switching over to Zepbound, he’s lost 60 pounds. His BMI is now 37, his blood sugar and blood pressure are under control, and he’s no longer considering knee surgery.

“Now I’m scared that all of those gains, if you will — losses rather, good losses — are going to go away,” he said.

When the FDA said the shortage was resolved, it noted that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain.” But Boesen, who worked as a long-time pharmacist before focusing on his law firm, said the agency’s approach seems to deviate from how it has handled drug shortages in the past.

“Traditionally, the FDA had been very conservative in making sure that there was enough to go around before they pulled [a drug] off the shortage list,” he said.

In a statement Thursday, the agency told STAT that it considers a shortage resolved “based on an evaluation of the entire market, assessing whether all backorders have been filled and supply is meeting or exceeding demand.”

Meanwhile, Lilly referred to the FDA’s website that says patients may not be able to immediately fill prescriptions “due to factors like ordering practices and incentives, cold chain logistical considerations, and retailer capacity constraints.”

For now, however, it’s not clear whether tirzepatide is off the FDA’s shortage list for good. As doctors try to get more patients onto the branded product, a surge in demand could cause the branded treatments to fall back into severe shortage.

Tchang, the obesity doctor at Weill Cornell, said she’s cautious about prescribing Zepbound to patients for that very reason.

“Before I get someone started on this pathway, I want to feel more confident in the supply,” she said. Otherwise, “we’re just creating more problems for the patient.”

Branded drug financially out of reach

Even if there is enough supply to go around, patients may still not be able to switch to the branded drugs due to their high price.

Many insurance plans either don’t cover obesity drugs or have in place strict guardrails that often prevent patients from getting approval for coverage.

Lilly,in a statement to STAT, put the burden on insurers, saying that the best way to ensure patients get access to “safe and effective” branded medicines is to increase coverage. Plans have balked at the price of the drugs, though, and some have even decided to drop coverage due to the costs.

Lilly recently started offering Zepbound in vials for a lower list price of $399 and $549 a month, depending on the dose, but critics said this move didn’t actually make the drug much more accessible.

Doctors noted that the price of the vials, equivalent to an average monthly payment on a used car, will still be out of reach for many patients, and only the starter doses will be offered in the vials, not the higher doses that many patients need to achieve significant weight loss.

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Additionally, not all patients will be able use the vials; they will only be available to patients who are paying for their own medication without insurance and who exclusively order through Lilly’s online direct-to-consumer portal.

Patients who use the branded drugs from Lilly are getting the gold standard versions that have been vetted by the FDA. Compounded medications, meanwhile, are not individually assessed by regulators, though the pharmacies’ practices are regulated by state boards or the FDA.

The FDA acknowledges the risks, too. “Although compounded drugs can serve an important medical need for certain patients, they also present a risk because compounded drug products are not FDA approved,” the agency said. “Generally, we recommend patients use the FDA approved drug when available.”

The availability of compounded weight loss drugs has been a major source of growth for some telehealth providers. Critics, however, have questioned whether patients who use the platforms are getting the same level of care that they would in a traditional clinic.

In a perfect world, there would be a more standardized system of regulating compounding pharmacies, with ratings given to indicate the level of quality of their products, said Tchang, the Cornell doctor. Still, for now, compounding “plays a role in meeting a niche that is unfulfilled,” and there are patients who are willing to take on some level of risk to be able to access medication.

“If all compounders suddenly stop making it, then we are going back to an era where the access to the medication is determined by how much you can pay out of pocket… [a patient’s] specific socioeconomic level, and what insurance determines we can access,” she said. “That doesn’t feel good either.”

Joshua Sharfstein, a former principal deputy FDA commissioner who is now a vice dean at Johns Hopkins University, said if supply of the branded drug is back up, it makes sense that compounders shouldn’t be able to make copycat versions anymore, because that would disincentivize drugmakers from continuing to make innovative medicines. But it’s also the case that branded drugs can be too expensive to be widely accessible.

“Two things can be true at once,” he said. Ultimately, “I think the best answer is for the authorized medicines to be more affordable.”

Elizabeth Cooney contributed reporting.