By 2029, more than 20 percent of people in the United States will be over the age of 65. That’s why the race to find effective treatments for Alzheimer’s disease feels urgent. A few drugs, approved well over a decade ago, can slow patients’ mental decline for some time. But everything else that has reached large-scale clinical trials, often with hopes of treating the underlying cause of the disease and halting its progress, has failed to show benefit, sometimes after hundreds of millions of dollars of investment.
With that track record—a nearly complete failure rate from 2002 to 2012—it’s hard to be optimistic.
Yet the late stage pipeline of potential new Alzheimer’s drugs is crowded, according to this recent analysis by the advocacy group USAgainstAlzheimers.
There is an outside chance a significant treatment could be available by the end of this decade, unlocking pent-up demand from possibly hundreds of thousands of people. Planning has to start now. A lot of resources, from imaging equipment to special clinics to trained staff, will have to be in place.
For example, three high-profile drugs now in Phase 3 studies would need to be taken intravenously once a month in an infusion clinic, a more complicated scenario than exists with current Alzheimer’s treatments, which are taken as pills. Biogen (NASDAQ: BIIB) CEO George Scangos, whose company is testing one of those drugs, called aducanumab, worried during a speech earlier this year that there wouldn’t be enough infusion centers to accommodate “millions of people.”
“Millions” is a stretch, at least in the short term, for reasons we’ll see in a moment. (Asked to clarify Scangos’s comment, Biogen spokeswoman Christine Falcetti said it was “an observation of the current situation” with Alzheimer’s, not a projection for aducanumab.)
But the worries about preparedness are real. I asked several dementia specialists across the country if the healthcare system is ready for the new wave of Alzheimer’s treatments, should they make it to market. What they had to say revealed a complex interplay between drug companies, health providers, regulators, and insurance companies, often with one group waiting for another to make progress before moving ahead.
Looming above it all, of course, is the ever-present debate over healthcare costs. Alzheimer’s is exacting a social, medical, and financial toll on aging societies like ours. Caring for people with dementia costs three times as much, on average, as caring for people of the same age and health profile minus the dementia, according to a 2010 report by the Alzheimer Study Group.
But can we afford to treat Alzheimer’s if and when a next-generation drug or drugs come to market? The Alzheimer’s Association says one in nine Americans over 65 have the disease. That’s 5.1 million total, more than 90 percent of all Alzheimer’s cases. And as noted above, we’re aging fast, with 10,000 Americans turning 65 every day.
If a new drug is approved, no matter what kind or what the label says about the patient profile it’s meant for, doctors are bracing for the visits. “A lot of these people will be the ‘worried well,'” says Zaldy Tan, medical director of the Alzheimer’s and Dementia Care Program at the University of California, Los Angeles, which sees people with all manner of memory complaints.
“If there’s a blockbuster we’ll probably have to change our system to accommodate it,” says Tan. It’s too early to make concrete changes such as hiring more staff, he says, but he worries about the impact to his center, which is already managing the care of about 1,300 patients. “It could be overwhelming. What happens to those who don’t have dementia but still have the need for specialists?”
At the Banner Alzheimer’s Institute of Phoenix, director Pierre Tariot says it will be hard to game-plan until one of the big drugs produces Phase 3 trial results. “That will give us a little time to model what volumes of people we’re talking about, although it could be several hundreds of thousands in the U.S. if it’s a biologic.”
About those volumes: Arguably the most promising drugs in the late-stage pipeline—the “biologics” that Tariot refers to—are being tested on people with mild Alzheimer’s, who could account for anywhere from 25 percent to 40 percent of total cases, according to various estimates. If one or more of those drugs is approved for those patients, not all of them would show up at the doctor’s office at once, of course, or even be diagnosed in time to take advantage of the new drugs. But the surge could be significant.
Those drugs—all monoclonal antibodies—work by clearing the protein amyloid beta, which forms clumps or “plaques” in the brains of people with Alzheimer’s. But anti-amyloid antibodies have not worked in people with more advanced disease—as demonstrated by some of the big clinical trial failures of the past decade.
The working theory is that they’re being administered … Next Page »