Telehealth companies and patients are grappling with the potential loss of access to cheaper, alternative versions of Eli Lilly’s popular GLP-1 weight loss drug tirzepatide after the FDA said its shortage has been resolved.
During the time that brand-name versions of tirzepatide, including Lilly’s Mounjaro and Zepbound, and the GLP-1 semaglutide, made by Novo Nordisk, have been in shortage, compounding pharmacies have been permitted to make copies of the drugs.
Hordes of telehealth sites, med spas and clinics jumped at the opportunity to prescribe the compounded versions, which aren’t FDA-approved but are often sold at prices significantly lower than their branded counterparts. Patients lacking generous coverage for weight loss shots flocked to them.
Novo’s drug semaglutide remains in shortage — and has been the preferred molecule for many of the biggest telehealth companies marketing the drugs. But there were also many pharmacies making versions of Lilly’s tirzepatide, as well — and one of the biggest telehealth companies had planned to do so.
Now, patients on compounded versions of the drug may face a choice: Switch to a pricier brand-name shot, opt for a cheaper, less effective obesity drug — or forego treatment.
“I suspect plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this,” Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in an email. “They are being cut-off cold-turkey, their prescription no longer fillable.”
Brunner added that it’s possible tirzepatide could be pushed back into shortage if many patients switch to FDA-approved versions of the drugs.
Lilly, which has pursued compounders with lawsuits and cease-and-desist letters, said Thursday that “entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately.” It has described compounded GLP-1s as risky and has said its own tests on the alternatives have revealed high levels of impurities.
Not stopping — yet
For now, though, some pharmacies and telehealth providers say they’re continuing to serve patients on compounded tirzepatide.
Arsenio Aaron, the owner of Fifty 410, a telehealth company in Dallas with 25,000 weight loss patients, told Endpoints News that he expects to be able to continue shipping compounded tirzepatide for several months before he can no longer provide the drug.
In anticipation of the tirzepatide shortage ending, and to provide a smooth transition for patients, Aaron said Fifty 410 switched from working with a 503A compounding pharmacy to a 503B outsourcing facility, which he said he believes has more time before it must stop providing compounded versions of brand-name drugs.
The FDA regulates 503B compounding pharmacies more strictly than 503A facilities by requiring 503B sites to adhere to current good manufacturing practices.
According to an August article by law firm Frier Levitt, neither type of compounding facility can make a copy of a commercially available drug, but 503B outsourcing facilities have a 60-day grace period in which they can continue filling existing orders. There is no grace period for 503A facilities, according to the firm.
After that 60-day period, Aaron said he expects some of Fifty 410’s patients — around two-thirds of whom are on tirzepatide — will lose access to weight loss treatment; others may switch to another drug. The company has also started prescribing brand-name GLP-1 medication and taking insurance to provide another avenue for access.
Another telehealth provider, Lavender Sky Health, said early Thursday that “consults, follow-ups, and refill requests for tirzepatide have been placed on hold” until it receives more information from its pharmacies, according to an email to a patient reviewed by Endpoints. But a memo posted to its patient portal said that after communicating with pharmacy leadership, it would still be able to fulfill orders, except in the case of one compounding facility.
The memo said Lavender Sky was “getting overrun with emails and refill requests as a result of the shortage concerns.” The company did not respond to requests for comment.
Some prominent telehealth providers, such as Hims and Ro, have prescribed only compounded semaglutide, which remains in shortage. Hims in the past has said it planned to provide compounded tirzepatide in the future. The company also previously told analysts that it expected to be able to continue offering compounded GLP-1 drugs under an exception that it says allows pharmacies to address patients’ clinical needs through compounding even outside of a shortage. Hims’ stock $HIMS was down 10% on Thursday.
“Whenever we bring a treatment to our platform, our first consideration is how accessible it will be for the large majority of customers and accessible means consistently available at a reasonable price. Through that lens, right now we’re focused on offering semaglutide and our oral therapies,” a Hims spokesperson told Endpoints.
Editor’s note: Zachary Brennan contributed reporting.