Some neurologists and a consumer watchdog are raising concerns that a direct-to-consumer telehealth platform affiliated with the drug company Eli Lilly — marketed to individuals concerned about memory loss — could lead to misdiagnoses or unnecessary treatment with anti-amyloids.
Lilly, which makes the once-monthly anti-amyloid infusion donanemab (Kisunla), announced in late March that patients would be able to quickly access a neurologist for diagnosis via its telehealth platform, LillyDirect.
The drugmaker said its aim is to “help people experiencing memory and thinking issues to overcome barriers to diagnosis and care.”
Eric Widera, MD, professor of medicine at the School of Medicine at the University of California, San Francisco, said he had doubts about Lilly’s motivation. “They’re a drug company, and they want to sell their drug,” Widera told Medscape Medical News.
As previously reported by Medscape Medical News, the US Food and Drug Administration approved donanemab for early Alzheimer’s disease in July 2024.
Lilly did not report any sales of donanemab until the fourth quarter, when it announced revenue of $8 million. Given the drug’s reported annual cost of $32,000, this suggests that approximately 250 individuals received the drug. In late March, the European Medicines Agency recommended against approving donanemab.
Widera said the telehealth platform could have some benefits, such as potentially earlier detection of dementia or Alzheimer’s disease or earlier referrals to specialists, but added that it wasn’t clear whether the clinicians providing consultations via the Lilly platform would be neurologists or neurologists trained in dementia diagnosis.
Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University School of Medicine, Washington, DC, told Medscape Medical News that telehealth can be useful for follow-up visits or for getting specialist care in remote areas. But it is also becoming “a tool for drug companies to essentially sell their drugs directly to consumers,” said Fugh-Berman, who directs PharmedOut, a Georgetown center that educates healthcare professionals and students about industry marketing practices.
Conflicts of Interest?
Widera and Fugh-Berman both said that the lack of financial details about the arrangement between Lilly and its partner Synapticure, a telehealth and disease management company focused on neurodegenerative diseases, is concerning.
There’s potential for conflicts of interest because Synapticure is being supported by Lilly to potentially offer a recommendation for treatment with donanemab, said Widera.
Researchers from Brown University in Providence, Rhode Island, recently reported in The New England Journal of Medicine that drug company/telehealth partnerships, such as LillyDirect, may violate the federal Anti-Kickback Statute. This law prohibits incentives for referrals or arrangements that could encourage clinicians to provide unnecessary or inappropriate care.
Lilly has reportedly said that it does not receive any compensation from telehealth companies for referrals and does not offer incentives for third parties to prescribe its medications.
A handful of senators, led by Dick Durbin, said Congress wanted answers about the arrangement. They “steer patients toward particular medications and create the potential for inappropriate prescribing that can increase spending for federal health care programs,” the senators wrote to Eli Lilly.
“Synapticure is fully independent of Lilly” and “exercises autonomous clinical judgment,” Eric Anderson, MD, Synapticure’s chief medical officer, told Medscape Medical News. He added that the telehealth company is “not incentivized to prescribe Lilly medications” or to meet any quotas and that the drug maker does not pay its physicians.
With a nationwide shortage of neurologists, Widera wondered how they could be so readily available through Synapticure.
Anderson said that Synapticure’s model is “very attractive” to neurologists. “Being able to be a 50-state specialty provider that is focused on providing access and comprehensive care to people who are hard to reach is a mission and vision that resonates well with neurologists,” said Anderson.
Questions on Diagnostic Accuracy
While Lilly and Synapticure say virtual visits can speed up diagnoses, some question whether those diagnoses will be accurate.
The process of getting in to see a specialist might be easier, “but what is the end result, and is that good for patients” asked Fugh-Berman. “How much of this is really making people who are normally functional into dementia patients?”
Anderson noted that some individuals who use the platform may already have a clear diagnosis of cognitive dysfunction or dementia, while others will have no diagnosis. A care navigator first checks whether the individual’s insurance covers a telehealth visit and asks for any available medical records, imaging, or lab results. If the person has not previously undergone cognitive screening, a trained navigator will administer the Montreal Cognitive Assessment or a similar test.
A Synapticure neurologist or geriatrician experienced in dementia care then reviews the records and tests and determines if the person is eligible for an in-depth evaluation via telehealth, said Anderson.
David Knopman, MD, professor of neurology at the Mayo Clinic, Rochester, Minnesota, said that increasing access to cognitive specialists is laudable. “There’s no question that the access to specialty dementia care is horrible,” Knopman told Medscape Medical News. However, he added, “Getting the right diagnosis is not trivial.”
Knopman said he had concerns about telehealth, especially if it is used for initial diagnosis.
“There’s nothing like a face-to-face, unhurried interview with a patient and informant by a specialist in person,” he said. Knopman said he conducted virtual evaluations during the COVID pandemic and found it “terribly inadequate,” especially for new patients.
“Since you can’t touch the patient or really watch them walk, or do the rest of the neurologic exam, all of the clinical information that would relate to, say, Lewy body disease and the motor disorders that can co-occur with it would be missing,” he said.
In addition, there are other potential pitfalls, said Knopman. He said that at the Mayo Alzheimer’s clinic, roughly half of the individuals evaluated are ultimately not suitable candidates for lecanemab or donanemab, often because they were previously misdiagnosed.
Both Widera and Knopman also wondered how patients who lived in some areas would be able to access PET imaging, an infusion center, or specialty care and follow-up monitoring if they were donanemab candidates.
Anderson said that Synapticure aims to connect patients with all aspects of care, including imaging, infusions, and safety monitoring. If any of these elements are unavailable — perhaps because of the patient’s geographic location — the treatment does not proceed.
Widera and Knopman reported no relevant conflicts.
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