Patients Need Better Policy to Benefit from Forthcoming Alzheimer’s Innovations
A wave of new innovations from several companies, including Biogen, Eli Lilly, and Eisai, have started to show promise in slowing down the harmful transition of Alzheimer’s disease into its most debilitating stages. But some have questioned whether these treatments would make a meaningful difference for Alzheimer’s patients or to society at large.
In a new University of Chicago study, we found that slowing the transition from the mildest forms of Alzheimer’s to its more severe stages would greatly benefit the 6.5 million Americans afflicted by the disease as well as their caregivers. It would also ease the burden on Medicare, which in 2021 bore the lion’s share of $321 billion in health care spending for Alzheimer’s patients—and a chunk of the $272 billion in additional caregiver costs.
Of course, realizing this value requires policies that allow patients to gain access to new treatments. The FDA is currently reviewing multiple promising new treatments that target amyloid plaque in the brain, one of the early indicators of Alzheimer’s. Recent evidence suggests promising clinical effects from these types of treatments. Unfortunately, FDA approval may not ensure access as CMS, the agency that administers Medicare, is currently restricting access to them. .
Typically, CMS covers FDA approved drugs, including drugs approved under accelerated approval -- a regulatory pathway FDA has employed for 30 years to facilitate earlier access to drugs that address serious conditions with an unmet medical need. But in 2022 CMS broke with norms by issuing a National Coverage Decision that restricted access not only to the first approved Alzheimer’s drugs but to all future drugs in the same class, yet to be approved. As it stands, even if FDA deems these news drugs safe and efficacious, CMS requires additional evidence generated through studies before it will cover them for Medicare patients. This will create significant access barriers for patients, as well as uncertainty for innovators about the path to market for new Alzheimer’s drugs.
Most debate has focused on the cost of approving these drugs because no robust assessments have examined the cost of not approving them -- until now. In our analysis, we considered the value of a potential new therapy for Alzheimer’s that would slow patients’ progression from mild to moderate disease by six months to three years—the range of future gains considered by many discussions in peer-reviewed journals. Before people reach moderate disease, they are much more likely to be able to do activities key to remaining independent, such as shopping and cooking, maintaining appointments and hobbies, talking on the telephone, and discussing current events.
We found that a when patients transition from mild to moderate Alzheimer’s disease, their health care costs triple. We calculated a one-year delay of this transition would have a value to the U.S. of $200 billion to $1.3 trillion over the next 10 years where the range reflects different proportions assumed treated and the valuation of health gains. When we added in patients with an even earlier form of Alzheimer’s, known as mild cognitive impairment, and we conservatively assumed they would experience the same length of the delay as mildly affected patients, we found the overall value could expand to a range of nearly $300 billion to $1.8 trillion.
Nearly 60 percent of this overall value stemmed from reduced health care spending, about one quarter from better health for both Alzheimer’s patients and their caregivers, and the rest to reduced burdens for caregivers. On an individual basis for a one-year delay, those values translate into $34.2 thousand per person from reduced health care spending, $7.9 thousand from reduced burden to caregivers and $23.6 thousand in improved health outcomes, using standard government metrics assessing the value in health gains of $150,000 per QALY (Quality Adjusted Life Year). Our aggregate values of delaying the disease were then obtained by multiplying these individual values with conventional estimates of the size of the mild Alzheimer’s population over the next decade.
Savings could be particularly large for Medicare, which covers nearly all Alzheimer’s patients and nearly half their total health care costs. We calculate Medicare would save up to $340 billion over a decade from innovations that delay patients’ transition from mild to moderate disease. Savings for patients with mild cognitive impairment could drive that number even higher.
Medicare coverage for new Alzheimer’s treatments could yield tremendous value for patients and their caregivers, taxpayers, and the health system at large. CMS should embrace these innovations and the potential relief they offer for this debilitating disease.
Mr. Philipson is an economist at the University of Chicago. He was a member and acting chairman of the President’s Council of Economic Advisers, 2017-20.
