Biden Administration Must Follow the Science By Expanding Access to Alzheimer’s Innovation

On Monday, the Veteran’s Administration announced it would cover a new FDA-approved treatment for Alzheimer’s disease. The decision came as a surprise because just a few weeks ago the Centers for Medicare & Medicaid Services (CMS) refused to expand coverage of the drug. The apparent conflict between agencies sends mixed signals on a topic requiring the utmost clarity. Solving Alzheimer’s is a top priority for the Biden Administration. It must embrace policies that provide broad-based access to the best possible care and foster innovation.

On January 6th, FDA granted accelerated approval for lecanemab, a monoclonal antibody treatment that can slow the progression of Alzheimer’s in its early stages. The Alzheimer's Association estimates that with each passing day, 2,000 people transition from mild to moderate dementia—that’s more than 120,000 people since FDA gave lecanemab the green light, many of whom would qualify for the treatment.

Yet CMS is moving in slow motion, only pledging to place lecanemab under “Coverage with Evidence Development”, a burdensome condition for drug sponsors, if it can achieve full FDA approval. The agency is supposed to focus coverage decisions on what is reasonable and necessary for Medicare beneficiaries without regard to cost. However, it’s hard to justify its Alzheimer’s decision any other way. When in 2021 FDA granted accelerated access approval for Aduhelm, an Alzheimer’s treatment similar to lecanemab, CMS preemptively raised 2022 Medicare Part B premiums nearly 15%—the largest hike in the program’s history – then decided to restrict coverage and subsequently promised to adjust 2023 premiums. 

What about the cost of not treating the disease? A University of Chicago study found that delaying the transition from mild to moderate Alzheimer’s could save as much as $1.3 trillion in healthcare costs over the next decade. About 40% of that is due to the life-changing improvements not only for people living with Alzheimer’s, but also for their caregivers who shoulder a tremendous burden as the diseases progresses. These gains can only be realized if CMS enables broad-based access to new treatments.

Unfortunately, the most likely scenario is one where CMS approves coverage only for people who participate in new clinical trials approved by the agency, so-called “Coverage with Evidence Development.” It has been employed 27 times since its inception in 2005 but never for a disease-modifying treatment—until Aduhelm, for Alzheimer’s disease. Using this policy for lecanemab, or any other FDA-approved treatment, would be a mistake.

For starters, creating new trials takes time patients don’t have. There are dozens of steps that need to happen—selecting an organization and investigators, establishing trial protocols, securing CMS approval, obtaining funding, training providers, and recruiting patients among many others—before a single patient can receive treatment. As a result, there are very few such trials available for potential participants. In 2019, 23 states hosted a clinical trial for Aduhelm, and only 1,643 participants enrolled.

Moreover, these trials are held at academic centers in urban areas, which makes participation difficult if not impossible for people living in rural areas. Take Ohio, where the number of Alzheimer’s patients is expected to spike by nearly 14% between 2020 and 2025. The only approved trial for Aduhelm took place at the Ohio State University Medical Center in Columbus—a four-hour roundtrip by car from Cincinnati. One resident who had moved from Nevada found it was easier to commute twice a month to a trial site in Las Vegas where he was enrolled.

CMS may try to justify this restrictive policy for new Alzheimer’s treatments based on safety concerns, but that’s not its role. FDA is the sole arbiter on product safety and efficacy—a power vested by Congress—and it alone has the deep expertise to evaluate complex data required to do so. CMS should stick to its role as Medicare’s administrator. If it doesn’t, Congress should act.

Twenty Senators sent a letter asking for reconsideration of the Administration’s Alzheimer’s coverage policy, only to be left wanting. That’s a good start, but more must be done. A united Congress can ensure CMS coverage decisions are in best interests of the American people, not Washington bureaucrats.

Joe Grogan is a visiting senior fellow at the USC Schaeffer Center and served as domestic policy adviser to President Trump, 2019-20. He consults for the healthcare industry, including those working to develop treatments for Alzheimer’s disease.