By After recent moves by weight loss companies WW and Noom into telehealth prescribing, drugmaker Eli Lilly is starting a service that will connect people needing medications for obesity, diabetes and migraine to virtual medical care and says it will deliver medications directly to their homes.
The new service, LillyDirect, marks the first time a pharmaceutical company has become so involved in care coordination and delivery of its products. It comes on the heels of the US Food and Drug Administration’s approval of its weight loss medication, Zepbound, in November.
Lilly says it has no financial relationships with the telehealth providers it has partnered with: 9amHealth, Forum and Cove. Clinicians engaged through the services are free to prescribe any medications, but if they prescribe certain drugs made by Lilly, patients will be eligible to get them delivered to their homes directly from the company, ensuring “consistent access,” Lilly said in a news release Thursday. Lilly’s drug discounts will also be automatically applied for those who qualify.
In addition to Zepbound, Lilly will offer certain kinds of insulin through the service as well as its monoclonal antibody for migraine, Emgality.
Zepbound mimics the actions of two hormones released by the gut after eating. It increases the production of insulin and slows the passage of food through the stomach and intestines, which may help a person feel full for longer. It also acts on the brain to turn down appetite and cravings. In clinical trials, it helped people lose an average of 20% of their starting weight after more than a year on the medication.
The active ingredients in Zepbound and a similar drug, Wegovy, went into shortage in 2022 after celebrities began openly discussing their weight loss on the drugs.
Zepbound is approved for adults who are obese, with a BMI of at least 30. It’s also approved for people who are overweight with a BMI of at least 27, who also have a weight-related medical condition such as high blood pressure or high cholesterol.
Lilly said Thursday that it “stands against the use of its medicines for cosmetic purposes.”
“Mounjaro and Zepbound are indicated for the treatment of serious diseases; they are not approved for – and should not be used for – cosmetic weight loss,” the company said in a news release.
It also cautioned about the safety risks of using compounded tirzepatide, the active ingredient in both Mounjaro, which is approved for diabetes, and Zepbound. Compounding involves mixing or altering the dosage of drugs to make medications tailored to the individual needs of patients. When drugs go into shortage, the US Food and Drug Administration allows compounding pharmacies to sell copycat versions to help fill in the gaps. Both tirzepatide and semaglutide, the active ingredients in Zepbound and Wegovy, are listed as being in shortage in the FDA’s database.
“Lilly is extremely concerned that some of the compounded tirzepatide that Lilly has tested has contained high amounts of impurities, and in at least one instance, was actually nothing more than sugar alcohol,” the company said.
Wall Street responded positively to the LillyDirect announcement, but researchers and patient advocates had questions.
“The idea that you have pharmacists and doctors who are devoted, in effect, to Lilly products does not seem in the best interest of patients,” said Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.
“I mean, what if, for some reason, the best drug for a patient was a non-Lilly drug? Do we really think that these telehealth providers are not going to push them towards the Lilly version?”
Lurie said it will be interesting to see how the FDA reacts. The agency regulates drug marketing and takes a broad view of what promotion looks like, counting things like medical conferences as within its purview. On the other hand, the FDA steers clear of weighing in on the practice of medicine.
LillyDirect seems to exist on the line between drug marketing and the practice of medicine, Lurie said.
“I think from a practical point of view, they’d be reluctant,” he said. “It does seem like it’s on the border, though.”
When manufacturers, packers, distributors or their representatives promote prescription drugs to consumers and health care providers, the FDA says, it requires these communications to be truthful, balanced and not misleading. The agency said its authorities may apply to telehealth providers and websites, depending on what activities they undertake and how they are structured. States also have laws that address prescribing and dispensing drugs.
Dr. Bree Holtz, an associate professor at Michigan State University who studies telemedicine, said she sees both benefits and risks in the new service.
“I think in rural populations, where educators and specialists are difficult to access, it could be good,” she said. In her work in diabetes, it is sometimes “nearly impossible” to find an endocrinologist within 50 miles, “so it could be great to have this extra resource.”
Holtz said she wonders about how coordinated care will truly be, though.
Electronic medical records systems typically don’t do a great job of sharing information with each other. If a person starts a drug through this service, she asked, “how is that information going to be relayed to a person’s primary care?” If they go to a pharmacy, will the pharmacist see their prescription and be able to advise about drug interactions? How much will insurance cover?
For the most part, Holtz said, she’s optimistic about the idea.
“Anytime people who can get care who aren’t now getting care, I think, is an addition and can help health care quality in the long-term,” she said.
