The Centers for Medicare and Medicaid Services doubled down on a controversial decision to limit patient access to new Alzheimer’s treatments.
At issue are monoclonal antibodies, “mAbs” for short, that target the amyloid brain plaques thought to be associated with Alzheimer’s patients’ cognitive decline. The Food and Drug Administration approved the first amyloid-fighting mAb, aducanumab, in 2021.
A Blow to the Alzheimer’s Community
But last year, CMS declared that the Medicare program, which it governs, would not cover any drugs in this class approved through the FDA’s accelerated approval process until more evidence proved their effectiveness. This means that the drugs will only be covered under CMS-approved clinical trials – resulting in very few patients having access.
This was a crushing blow to millions of patients and their families. Alzheimer’s is a degenerative condition, so early treatment is critical, and delays can cost patients ground they can never make up.
A Second Try, A Second No
Late last year, the Alzheimer’s Association appealed CMS’ coverage decision. Importantly, the appeal was not simply a request for the agency to reconsider. It also offered new, game-changing clinical evidence.
In November, the New England Journal of Medicine published research showing a new amyloid mAb, lecanemab, slowed Alzheimer’s patients’ mental decline by 27% over 18 months. The lecanemab study yielded unprecedented success in a double-blind, placebo-controlled trial that included substantial proportions of Black and Hispanic patients, who are disproportionately vulnerable to Alzheimer’s. More than 200 Alzheimer’s researchers signed a statement to “herald the foundational advance represented by the advent of lecanemab therapy.”
Despite this, CMS still said no – because, they said, lecanemab was also approved via the FDA’s accelerated approval pathway, not the traditional process. This decision to double down stunned the Alzheimer’s community, which now has two FDA-approved medications with highly limited Medicare coverage.
A Catch-22
For the Alzheimer’s community, this is a Catch-22. The FDA only selects drugs for accelerated review if they fill an unmet medical need in the fight against a serious disease. Amyloid mAbs for Alzheimer’s, by definition, fit those criteria.
In contrast to CMS’ approach, the Veteran’s Health Administration recently announced that it will cover lecanemab for veterans with Alzheimer’s. The decision puts the two federal agencies out of step when it comes to providing access to the most recently approved medication.
The fight for access to cutting-edge Alzheimer’s treatments is a fight against the ruthless clock. For now, though, Alzheimer’s patients on Medicare are left with the cruel irony that CMS refuses to cover FDA approved medications that have the potential to help them because the treatments were approved under a program designed to get them to patients quickly.
