Alzheimer’s sufferers slow to pursue newly approved drugs
Obstacles include cost, infrastructure, patient hesitancy
A host of hurdles are slowing the adoption of the new Alzheimer’s drug Leqembi, experts involved in the treatment of patients said, from complicated logistics to the fact that many people don’t recognize that their memory loss is a disease soon enough.
some patients still grapple with whether they want to be diagnosed, even though a treatment exists, the experts said, speaking during a recent sTAT virtual event.
“Even the word for dementia does not always exist in every culture and in every language,” said hollis day, chief of geriatrics at Boston medical center and a professor at Boston University’s medical school. “And so just getting people to accept that memory loss is not normal aging necessarily is a big barrier to getting people into diagnosis early enough to benefit from these treatments.”
When the Food and drug Administration granted full approval to Leqembi nine months ago, it was a triumph decades in the making. The medicine is the first treatment approved to combat the buildup of plaques of a substance called amyloid in the brain, a hallmark of Alzheimer’s, and it slowed patients’ functional decline during a large clinical trial.
But uptake of the drug has so far been sluggish, according to financial reports by Eisai and Biogen, the drug’s
makers. In its most recent quarterly report, Cambridge-based Biogen reported Leqembi sales of $19 million, triple that of the previous quarter — but still far short of forecasts by Wall Street analysts that say the medicine could eventually generate sales of billions of dollars a year. A similar medicine from Eli Lilly, donanemab, is awaiting FDA approval and will go before an advisory panel on June 10.
The three experts participating in the virtual event agreed that the problem of diagnosing patients with early stage Alzheimer’s disease was a major obstacle in getting them treatment. But it was only the first.
For instance, Day said, it is very difficult to explain to patients that Leqembi is not a cure for Alzheimer’s but instead a way to slow their decline.
Lisa M. Renzi-Hammond, a professor at the University of Georgia who co-directs the Cognitive Aging Research and Education Initiative, an effort to reach people in rural areas in Georgia with neurology care, said the problem can also extend to the primary care physicians who treat Alzheimer’s patients.
“A lot of our primary care providers, they’re family medicine folks,” said Renzi-Hammond. “They’ve watched their older loved ones go through Alzheimer’s disease, and they very much think it’s ... normal aging, right?”
Many are hesitant to diagnose Alzheimer’s early because it will only add stress for patients’ families. Even once patients are diagnosed with cognitive impairment, the hurdles to starting treatment are high. Renzi-Hammond noted that many patients don’t have immediate access to the neurologists who do the work-ups for disease, the PET scanners that are used to identify the hallmark clumps of amyloid plaque in the brain, or the magnetic resonance imaging scanners used to monitor patients for safety.
“The problem isn’t this drug. Sure. It has risks,” said Jason Karlawish, co-director of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
Karlawish said his memory center infused its first patient with Leqembi on Nov. 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
Stitching together that treatment delivery system is labor-intensive. First, doctors must accurately diagnose mild cognitive impairment, memory loss that can be a sign of early Alzheimer’s. Then they must image the brain to look for small bleeds, and separately to look for markers of amyloid. Patients must also be tested for the APOE4 gene variant, which can affect how patients respond to Leqembi and similar drugs. They and their families must be counseled about the gene, which also increases the risk of developing Alzheimer’s disease in healthy people.
The drug has to be given intravenously over the course of one hour, via infusion. Access to places where this can be done represents another obstacle. Renzi-Hammond noted that this set of problems is not unique to Alzheimer’s. For patients with strokes, giving a clot-busting drug soon after a stroke occurs can improve outcomes. But for patients in one of the counties that her group tries to reach, the time between when those patients experience the onset of stroke symptoms and when they actually arrive at an emergency department averages 26 hours — far too late to benefit from such drugs.
The slow uptake of the new Alzheimer’s drug — which, the doctors noted, is expensive (list price: $26,500 a year) and which Karlawish said can cost patients thousands of dollars after insurance — is a symptom of larger problems with the health care system. Even before the development of effective therapies, Karlawish noted, there were plenty of reasons to diagnose Alzheimer’s. Studies decades ago showed that patients and caregivers benefit from access to long-term care and support. “The problem is we never built a system that delivers long-term care services and support,” Karlawish said.
New technologies and medical advances, the experts said, will lead to wider access. With regard to Leqembi itself, a newer version of the drug will likely be given as a shot, not an intravenous infusion. Blood tests could eventually be used to identify which patients have amyloid in their brains.
But solutions can be tougher to put into practice than one would expect. One obvious way to help patients in rural areas would be to offer them appointments via telehealth. But RenziHammond said when they offered telemedical evaluations to rural patients, they heard a “resounding no.”
There were questions around privacy, and around quality of care.
“It was not the slam dunk that I thought it would be.”