Alliance Advocates for Equitable Access for Alzheimer’s Patients Seeking New Treatment

The Institute for Clinical and Economic Review (ICER) held a meeting today to discuss Leqembi (lecanumab), an FDA-approved treatment proven to slow the rate of cognitive decline among patients in the early stages of Alzheimer’s disease. Alliance President & CEO Sue Peschin, MHS, gave public comment during the meeting:

Hello, everyone. I’m Sue Peschin. I serve as president and CEO of the Alliance for Aging Research. Thank you for the opportunity to comment on the evidence report.

I will start by providing some context. ICER reports like the one being discussed today are crafted for health insurance companies. That is the lens through which ICER views people living with Alzheimer’s disease—as if they are insurance products nearing the end of their useful life.

Today we’re talking about the value of an FDA-approved treatment called Leqembi that slowed progression of early Alzheimer’s by 5.3 months over an 18-month trial. Even some neurologists who were skeptical of Aduhelm say Leqembi could be a game-changer. The Alzheimer’s Association, the American Academy of Neurology, and more than 200 research experts in the space have asked CMS to revise its extreme Medicare coverage restrictions. Earlier this week, the Veterans Health Administration—which routinely utilizes ICER’s reports in their formulary determinations—announced that it will widely cover Leqembi.

With that context in mind, I want to make a few points about ICER’s Leqembi report.

First, ICER utilizes its equal value of life years gained—or evLYG—metric in the report. However, claims that it fixes the biases of the QALY are misleading. The only difference between the evLYG and the QALY is that the evLYG uses a static health state preference value of .85 as opposed to using values that vary by condition. The calculation is done the same way for both—by multiplying the amount of time patients are likely to spend in their disease state. Both measures consider treatments that cure disease or extend life as more cost-effective than treatments that primarily improve quality of life. The National Council on Disability considers the evLYG discriminatory, and so do hundreds of patient advocacy organizations—including the Alliance.

We are concerned about how the evLYG measure is being showcased by ICER as a reasonable alternative to the QALY.  The Inflation Reduction Act allows Medicare to set prices starting in 2026 and left the door wide open to how it will be operationalized. The evLYG maintains the same discriminatory lineage as the QALY and should not be considered a viable alternative.

Second, ICER’s methodologies have a uniquely negative impact on communities of color, who experience a higher prevalence of Alzheimer’s, are often diagnosed at later stages of disease, and with more comorbidities—all factors that force the cost-effectiveness threshold for treatment to rise.

In the equity white paper ICER released two days ago, they openly acknowledge that the status quo of traditional cost-effectiveness methodology is “no longer acceptable.” In its Leqembi report, ICER uses a tortured “Health Improvement Distribution Index”, or HIDI. The HIDI estimates that Black Americans would receive 1.6 times the health improvements from Leqembi as compared to the same sized group of Americans without regard to race. However, this HIDI metric is in the report’s “contextual considerations,” which aren’t included in ICER’s base case value assessment and final recommendation. So, what’s the point here? Making up a new equity metric that you don’t use—rather than doing the hard work of wholesale reform to your base assessment—is tokenism rather than real reform.  

Third, ICER’s Leqembi report penalizes family caregivers for the productivity and economic impacts of keeping a loved one at home. In its response to submitted comments on the draft, ICER states that, “This treatment is not restoring to a health state that doesn’t involve caregiver time spent.”

From the perspectives of people living with Alzheimer’s, family caregivers, and society, there is significant intrinsic value to prolonging independence and identity that is not reflected in medical costs or solely captured in caregiving burden. That represents real time—time where cognition, personality, and the ability to care for oneself remain largely intact. If this value is not reflected in the value assessment, that is a deficiency in ICER’s model.

Individuals living with Alzheimer’s 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 ICER, private payers, and Medicare to insert themselves between patients and their doctors, in terms of that benefit-risk assessment. None of ICER’s health economists know better than the biomedical experts at the FDA or people’s doctors. More importantly—none of you know what matters most to people living with Alzheimer’s and their families.

Dr. Pearson, both last year and at this meeting you spoke poignantly about your mom and your family’s experience with Alzheimer’s. I’m sure you would agree that it would be inappropriate for ICER to help set up a scenario in which middle and low-income people can’t get coverage, all the while knowing wealthy Americans can private pay for any medication they might want to have for themselves or their loved ones.

Thank you for the opportunity to present.