Good news is rare these days, so it’s worth celebrating the remarkable results that Eli Lilly reported Wednesday from a late-stage trial on its experimental Alzheimer’s drug. If only the Biden Administration would now let seniors have access to such breakthrough treatments.
Lilly’s monoclonal antibody donanemab works by clearing amyloid plaque in the brain that is a characteristic of Alzheimer’s disease. The cause of Alzheimer’s isn’t known, but many researchers believe that plaque that builds up over decades can cause a cascade of neurological degeneration. Others disagree.
Yet donanemab is the third treatment to demonstrate that removing amyloid can slow and perhaps even arrest disease progression. In a late-stage trial with more than 1,700 patients, donanemab slowed cognitive decline on average by 36% over 18 months. Nearly half of patients who received the drug showed no decline after a year.
Lilly’s results may even be more impressive than those for two other anti-amyloid treatments, both by Biogen and Eisai, approved by the Food and Drug Administration over the past two years. Critics claimed those earlier trial results—which showed roughly 25% slower decline—weren’t clinically significant. The Biden Centers for Medicare and Medicaid Services apparently agreed.
In an unprecedented move, CMS last year restricted access to all anti-amyloid antibody treatments approved by the FDA. The agency claimed it wasn’t convinced the treatments are “reasonable and necessary.” So now seniors who want access to Alzheimer’s treatments must enroll in government-approved studies or pay tens of thousands of dollars out of pocket.
Since large-scale trials can only be conducted at large medical centers in urban areas, patients in most of the country can’t get treatments. No other FDA-approved drug entails such coverage restrictions, so why is CMS discriminating against sick seniors? Perhaps it’s worried the drugs could balloon Medicare costs.
But this is no reason to restrict access to a drug that could help millions of Americans, and CMS isn’t permitted to ration treatments owing to cost. The Veterans Health Administration has agreed to cover Biogen and Eisai’s Lecanemab. CMS’s restrictions are increasingly untenable as evidence of the drugs’ benefits and political blowback grows.
Twenty Senators, including Democrats Gary Peters and Amy Klobuchar, plus 74 House Members including 38 Democrats have urged CMS to remove its restrictions. Their pleas were echoed last week by 23 state Attorneys General, including progressives such as Minnesota’s Keith Ellison and Oregon’s Ellen Rosenblum. CMS’s coverage restrictions create “a barrier to care for older Americans, especially individuals living in rural and underserved areas,” the AGs noted.
After decades of Alzheimer’s drug setbacks, treatments finally show they can slow decline even if they aren’t cures. CMS’s denial is typical of government-run health systems that deny treatment because of cost concerns. It shouldn’t happen in the U.S.
If President Biden were an ordinary Joe living with Alzheimer’s, wouldn’t he and his family want access to Lilly’s treatment?