The FDA is expected to grant full approval soon to the Alzheimer's therapy lecanemab (Leqembi). When that happens, physicians and their patients will have to navigate the path to access and reimbursement, and wrestle with concerns over side effects and cost.
But before those questions can be addressed, a baseline challenge awaits: who are the people who can benefit most from treatment, and how can they be identified? Similarly, who are the people most at risk of developing any form of dementia?
Clinical trials show that lecanemab can be highly effective in clearing the brain of amyloids, the plaque-like substance closely associated with Alzheimer's. Physicians must of amyloid beta pathology before starting treatment.
Reducing amyloids in individuals who have advanced symptoms, however, is pointless. The amyloids need to be cleared before they can ravage the brain, which puts greater emphasis on cognitive screening to find individuals most at risk.
Not Enough Cognitive Screenings
Just over one-third of older Americans report being assessed for cognitive issues. Medicare requires that a comprehensive cognitive assessment be included in each enrollee's annual wellness visit, but of those who have a wellness appointment report undergoing a formal cognitive screening.
This situation must change if the country hopes to acquire the basic information needed to forestall a tsunami of cognitive afflictions. of the U.S. population over 65 has mild cognitive impairment. An Americans had Alzheimer's disease in 2021, with the number projected to double by 2050 because of the increasing population of U.S. adults ages 65 and older. For individuals, lack of screening can be an existential issue.
Physicians and researchers, including myself, are looking for ways to make cognitive assessments a regular feature in preventive care. One recommendation to Medicare, private insurers, and health policymakers is to adopt a brief cognitive assessment that can be used in primary care to identify individuals who need more thorough diagnostic workups.
How a Brief Assessment Would Work
To be useful, the assessment will need to be valid in diverse populations, available in various languages and in digital and paper-based forms, and be sensitive to early stages of decline. To be palatable to overworked primary care practices, it will need to be truly brief -- no more than 10 minutes -- and have the potential to be integrated into electronic health records.
Attending issues would have to be addressed. Non-physician healthcare professionals would need to be trained. Primary care doctors would need guidance on communicating the results of a brief cognitive assessment to patients and on making referrals. Medicare would need to step up enforcement of its requirement for detecting cognitive impairment at annual wellness visits, and should establish a medical code for brief cognitive assessments to ensure adequate reimbursement.
A Big Payoff May Await
The payoff for such efforts would be a dramatic increase in identifying people at high risk of developing dementia. They could get more timely treatments, begin to change diets and lifestyle habits, and take steps to plan for the future that could make a significant difference in their lives.
Longstanding neglect of detection of cognitive impairment has resulted in a hidden epidemic. As our understanding of the biology of neurodegenerative diseases improves and better treatments emerge, we need to identify the patients who can benefit from those innovations and do so in a timely and equitable manner.
is co-director of the Aging and Cognition Program at the USC Schaeffer Center for Health Policy & Economics.