Telehealth companies are split on compounded GLP-1s

Weight loss-focused telehealth companies are examining the pros and cons of using compounded versions of glucagon-like peptide agonist medications.

The rising popularity of branded GLP-1 medicines such as Novo Nordisk's Wegovy and Ozempic have drawn numerous digital health and direct-to-consumer companies into the space. But shortages and costs of these drugs led companies to sell compounded GLP-1s, which use similar ingredients to some of the popular weight loss medications.

Telehealth companies are split on whether to sell compounded GLP-1s. Those offering the compounded drugs say they give consumers greater access and lower costs, while those against them say the drugs are a threat to patient safety.

“Anybody can sell compounded GLP-1s right now. Anybody,” said Brooke Boyarsky Pratt, founder and CEO of weight management company Knownwell. “This is [exactly] what should be giving everybody pause.”

Novo Nordisk and Eli Lilly, which manufacturers branded GLP-1 medications Mounjaro and Zepbound, have pushed back in response to the increase in compounded GLP-1s.

Read more: Ozempic is huge. Here’s who’s jumping into telehealth to sell it.

Novo Nordisk said in a statement it has filed 21 lawsuits and will continue to pursue legal action against entities it claims are unlawfully marketing and selling compounded drugs containing the same ingredients as Ozempic and Wegovy. Eli Lilly said in a statement that compounded GLP-1s are not copies of its branded medications. An Eli Lilly spokesperson said some entities selling compounds have "invented a new, unregulated way to mass-produce unapproved drugs."

While the Food and Drug Administration authorizes compounding GLP-1s during shortages, the long-term viability of this approach remains an open question. Branded GLP-1 drugs are becoming more widely available after over two years on the FDA's shortage list.

Compounding companies defend practices

Hims & Hers announced its intent to sell compounded GLP-1s in May. CEO Andrew Dudum said the company’s decision came after a year and a half of deliberation and vetting various compounding partners. Dudum said Hims & Hers views the business segment as a long-term offering.

“If a company is telling you that they're not [compounding] for a lot of reasons that makes sense. It is very challenging,” Dudum said. “You have to do it with the utmost safety, and it requires large scale, a lot of dollars and an incredible amount of expertise.”

Hims & Hers, which also offers medications and treatments for conditions such as hair loss and mental health, has placed an emphasis on its weight management segment. The company added longtime Novo Nordisk executive Kåre Schultz to its board of directors in July.

Still, there are risks to Hims & Hers' plan, according to Jack Wallace, vice president of equity research at investment and advisory firm Guggenheim Partners. Hims & Hers faces legal and regulatory risks that could prevent its compounding pharmacy partners from manufacturing GLP-1s, he wrote in an analyst note Aug. 6.

Dudum said the company was "very aware" of what is and is not allowed under the FDA's compounding exemption.

Ro, another direct-to-consumer telehealth company selling compounded drugs, is focused on giving customers greater access to medications. Ro co-founder and CEO Zachariah Reitano declined to share specifics on how the company’s offerings might shift as manufacturers ramp up supply of branded medicines. He said the vast majority of Ro's patients want brand-name drugs.

“Compounding is also a great option for [patients] during a shortage to maintain access or, in some instances, if their insurance is unable to cover it," Reitano said. "We have seen compounding in many instances serve to increase health equity and access to these new treatments."

Companies not selling compounded drugs cite safety concerns

Telehealth companies that are not offering compounded GLP-1s cite patient safety as a primary concern. Boyarsky Pratt said Knownwell gets 10 emails per week from companies, primarily located in China, proposing to sell it cheap GLP-1 compounded medications.

“We just think it's super-unsafe,” Boyarsky Pratt said. “There is a reason these drugs go through a really long process in which the manufacturing capabilities of the companies making them, like Eli Lilly and Novo Nordisk, are well-documented and well-monitored.”

Last month, the FDA said compounded drugs pose a higher risk to patients than FDA-approved medicines because they do not undergo the agency's premarket review for safety, quality or efficacy. The agency said compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved medication.

Form Health, which provides telehealth weight loss care to patients through employers and payers, also has no plans to offer patients compounded medications.

"This is extremely questionable from a safety perspective," Form Health founder and CEO Evan Richardson said. "This is a push for them to keep that channel open and keep that line of business open. I think it is quite transparently nothing more than that."