People Living With Early Alzheimer's Need President Biden’s Help
One year ago – on April 7, 2022 – 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. CMS's requirements for such a study are so stringent that in the year since the decision, one has not even been proposed, much less launched.
The reason, although CMS equivocates on this, is to save Medicare money. CMS is a payer, and CED has become an efficient way to ration items and services estimated to create a higher cost burden in Medicare Part B, which covers drugs administered in clinics and doctor's offices.
Once CMS places a treatment in CED, it's extraordinarily difficult to reverse the decision. An August 2022 review in The American Journal of Managed Care identified that between 2005-2022, CMS denied coverage under CED for 27 different therapies. Only four of the denials have been retired by the agency, and several of the current 22 CEDs "studies" have been ongoing for more than 15 years.
CMS has applied CED rationing to procedures for severe hearing loss (cochlear implants), less-invasive heart valve replacement, and stem cell transplant for certain cancers and sickle cell disease. 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. Worse, CMS has exploited inequitable participation in existing CED clinical studies as justification to keep CED going – creating an endless loop of inequity and restricted access.
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. Last month, the Veterans Health Administration announced that it will widely cover Leqembi.
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.
Delaying progression in early disease represents real time—time where cognition, personality, and the ability to care for oneself remain largely intact. If this value is not reflected in Medicare's assessment of what should be considered "reasonable and necessary," that is a deficiency in the way CMS' leadership is looking at this drug.
Individuals living with Alzheimer's, or any life-threatening illness, meet with their health care providers, often alongside family caregivers, to discuss the benefits and risks of whether to take a drug or not. It takes a lot of hubris for CMS to insert themselves between patients and their doctors in that benefit-risk assessment.
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.
