People Living with Early Alzheimer's Need President Biden's Help
By Sue Peschin
Last year, the Centers for Medicare & Medicaid Services (CMS) announced that it would refuse to cover an entire class of FDA-approved therapies for the treatment of mild cognitive impairment and early dementia due to Alzheimer's disease. CMS' decision effectively cut off access for the vast majority of beneficiaries living with early Alzheimer's, except those wealthy seniors who could choose to pay out-of-pocket.
The decision, and its aftermath, does not represent what President Biden says he values, which is people. It was a shocking and disheartening illustration of what happens when bureaucrats crunch numbers and forget about the people behind the math.
CMS applied an extralegal tool called "coverage with evidence development" (CED) to all monoclonal antibody therapies for early Alzheimer's. Under a CED, Medicare denies coverage for an FDA-approved item or service, except for treatments provided through a very narrowly constructed clinical study.
Once CMS places a treatment in CED, it's extraordinarily difficult to reverse the decision.
But, the agency's April 7, 2022, Alzheimer's coverage decision was the first time CMS applied CED to an on-label use of an FDA-approved drug. There are strong signals from CMS that it won't be the last, as gene and stem cell therapies for cancer and rare diseases continue to progress through clinical development.
A report on CED called Façade of Evidence: How Medicare's Coverage with Evidence Development Rations Care and Exacerbates Inequity, issued by my organization, found that Medicare beneficiaries of color and those living in rural areas are more likely to be denied access under CEDs because the rigid conditions of coverage primarily direct care to urban medical centers in wealthier areas.
The FDA recently approved a second monoclonal antibody treatment called Leqembi that slowed progression of early Alzheimer's by 27% over an 18-month trial. Many neurologists who were skeptical of the first drug say Leqembi could be a game-changer.
However, the Alzheimer's community, including the American Academy of Neurology and more than 200 research experts in the space, have had to plead with CMS to revise its extreme Medicare coverage restrictions. So far, CMS has rejected those requests.
As the president notes in his November 2022 Proclamation on National Alzheimer's Disease Awareness Month, "Alzheimer's is common and especially cruel, robbing people of their memories, thoughts, and identity over many years. Across the Nation, this epidemic is growing: In the next 30 years, the number of Americans with Alzheimer's is expected to reach nearly 14 million, straining families and our health care system. Fortunately, we are on the cusp of life-saving advances that can forever change the course of the disease."
We completely agree. He needs to step in so people living with early Alzheimer's get a fair shot at more time with their families.
Sue Peschin is the president & CEO of the Alliance for Aging Research in Washington, DC.
