Alliance Comment on Advisory Council on Alzheimer’s Research, Care, and Services

The following statement was made today by Sue Peschin, MHS, President & CEO of the Alliance for Aging Research, during the public comment portion of the U.S. Department of Health & Human Services winter 2024 meeting of the Advisory Council on Alzheimer’s Research, Care, and Services.

Today’s meeting notice states that the Advisory Council would hear “updates from the field on implementation of disease-modifying therapies for Alzheimer’s.”

Given the subject, it seems reasonable for this advisory council—and the public—to expect to hear a 6-month update from CMS on Medicare access to Leqembi, including answers to such questions as:

❓ How many Medicare and MA claims have been paid so far?

❓ How many beneficiaries are enrolled in the 3 CMS-approved research studies?

❓ How many private insurance claims have paid for Leqembi? and

❓ How many patients have had to access treatment through private pay?

But we heard no report today.

Instead, we heard ongoing Leqembi research questions and other questions in the field. And while there’s still a good amount we don’t know, this isn’t unique to ADRD treatments.

In fact, it’s common not to know how a new cancer therapy impacts every potential patient. We allow patients and families to speak with their clinicians and decide what’s best for them. This is done without erecting complicated coverage barriers—because we get that cancer robs people of time, and time is of the essence.

Why do we have a different standard for Alzheimer’s?

We’re also concerned that CMS may tie the NIA’s $300 million real-world data platform to Medicare coverage as its designated registry. This would set a disturbing precedent for CMS putting the NIA—and the NIH broadly—in the business of helping with CMS payer utilization management and inserting itself between patients and their doctors.

In fact, section 1801 of the Medicare law explicitly bars CMS from supervising or controlling clinical care. Yet, that’s how its Medicare CED coverage policy is being applied.

This behavior undermines the FDA’s authority as the nation’s real biomedical agency, charged with ensuring the safety and efficacy of medical products.

So, I implore someone here today to join us in advocating for answers about Medicare access. Thank you.