Eli Lilly’s recently announced plan to partner with digital health company Ro on its LillyDirect platform marks a new turning point in the direct-to-consumer push among Big Pharma companies.
Ro, which launched in 2017, offers online prescriptions under the “wellness” bucket including drugs aimed at obesity, sexual health and hair loss — a model similar to digital health companies like Hims & Hers.
Under the partnership, Ro is now integrated with LillyDirect — the pharma giant’s DTC platform for diabetes, migraine and obesity — allowing customers to seek out Lilly’s blockbuster weight loss medication Zepound in a new formulation. In August, Lilly released Zepbound single-dose vials at around a 50% discount. Ro now offers the single-dose vials, the injectable pen, as well as Novo Nordisk’s Ozempic and Wegovy semaglutide pens.
At the same time, Ro also competes with the branded versions through compounded semaglutide drugs for weight loss.
Lilly and Novo, the undisputed leaders in the obesity market, have been locked in a battle with pharmacies that make compounded versions of their GLP-1 medications. Under FDA rules, compounded medications are allowed to be sold when the FDA-approved, brand versions are in shortage. And the FDA is currently reviewing a shortage decision on GLP-1s that has kept compounded versions on the market.
The integration reflects how Big Pharma companies are adapting to the DTC trend and seeking market share while simultaneously fighting to take compounded GLP-1s off the market. Lilly’s deal with Ro also comes as lawmakers question whether pharma’s DTC platforms are even legal.
Compounded complications
To strike the partnership, Ro strove to maintain “independent clinical decision making,” according to CEO Zach Reitano, which was also important to Lilly. That independence means Ro will sell compounded semaglutide as long as the law allows.
“We will continue to follow all applicable laws and FDA guidance as it relates to compounding, ” he said. “We believe in the premise of compounding and the role it plays in the healthcare system, and that providers should have access to that tool.”
The FDA is scheduled to update its compounded GLP-1 shortage review Dec. 19, but the agency could delay that decision. In October, the FDA removed Lilly’s Zepbound and diabetes drug Mounjaro from its shortage list, requiring compounding pharmacies to stop manufacturing and selling their versions of the drugs. After a group of compounders sued, the FDA reversed its decision, leading to the current limbo.
Notably, Ro doesn’t sell compounded versions of tirzepatide, the ingredient in Lilly’s GLP-1 drugs, but it does sell compounded semaglutide. Novo’s semaglutide weight loss drug Wegovy was marked as being in a supply shortage on Ro’s website as of Dec. 17.
“These drugs are quite effective. Patients want it, providers want it and the product is also quite scalable."
Zach Reitano
CEO, Ro
Thanks to the discount on Ro, Zepbound single-dose vials also cost closer to what patients pay for compounded GLP-1s from other telehealth providers, and significantly less expensive than the injectable pens, which have a list price around $1,000 per month. Through Ro, the vials cost $399 for the first month’s supply and $549 every month afterward.
“It's the most affordable brand of GLP-1,” Reitano said.
According to Reitano, Ro isn’t targeting patients who want to switch from compounded GLP-1s to the name-brand but less pricey Zepbound vials. Instead, the strategy is to offer branded products and compounded versions based on availability.
DTC expansion
As Lilly seeks a wider market share for Zepbound, Senators have continued to raise questions around the legality of pharma companies selling prescriptions directly to patients through online healthcare providers. Earlier this fall, a group of Senators sent letters to Lilly and Pfizer, which launched its own PfizerforAll DTC platform this year, to determine whether the platforms violate anti-kickback laws.
Lilly and Pfizer recently responded by pointing out that telehealth providers are not being paid to prescribe their medications. Lilly also asked Senators to question compound pharmacies directly, according to Endpoints News.
Pfizer stated it pays a monthly fee regardless of what telehealth providers prescribe.
Lilly and Pfizer are the first Big Pharma companies to launch DTC platforms, but more could be on the way, particularly for drugs targeting obesity.
“Obesity is unique in the sense that the majority of the U.S. population is overweight or obese,” Reitano said. “These drugs are quite effective. Patients want it, providers want it and the product is also quite scalable. [This has] never occurred at the same time for a drug class.”
Digital health companies that offer obesity solutions, including Ro, could also benefit from the incoming Trump administration's planned focus on chronic disease management. Robert F. Kennedy Jr., who was nominated to lead the Department of Health and Human Services, has stated a commitment to reducing chronic disease rates, including obesity, within a few years. He also publicly harped on the high cost of Ozempic in the U.S. compared to other countries.
“I'm optimistic about this new administration. I think that both the current and the new administration, while they don't agree on much … agree on the overwhelming burden of chronic disease in the U.S. and the fact that drug prices are too high,” Reitano said.