Washington, DC (April 13, 2023) – In a letter sent yesterday to Health and Human Services Secretary Xavier Becerra, UsAgainstAlzheimer’s called on Becerra to clarify inconsistent statements he made during key Senate committee hearings recently regarding the Centers for Medicare and Medicaid Services’ (CMS) refusal to provide Medicare coverage for promising new Alzheimer’s drugs, like Leqembi. 

The coverage denial was not based on analysis of the drug but was instead rooted in CMS’ coverage with evidence development (CED) from last year, which rejected Medicare coverage of every drug in the same class – even before data was available. Secretary Becerra also incorrectly stated that Leqembi had not completed clinical trials when results from Leqembi’s phase III confirmatory trial were already published four months prior and remain widely available

“These misstatements and others you made during these hearings could leave many people with the wrong impression of the CMS decision to not cover Leqembi and any future mAbs,” UsAgainstAlzheimer’s chair and co-founder George Vradenburg wrote. “I urge you to correct the record so lawmakers and the public have an accurate assessment of these important issues, and to direct CMS to, in fact, ‘remain consistent in the way it treats drugs.’”

The full text of the letter is below.

April 12, 2023 
The Honorable Xavier Becerra
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201 

Dear Secretary Becerra: 

During your recent testimony before key Senate committees, Senators asked you about the Centers for Medicare and Medicaid Services (CMS) decision to not provide Medicare coverage for Leqembi – a new Alzheimer’s disease (AD) medication the Food and Drug Administration (FDA) approved on January 6, 2023, via the FDA’s Accelerated Approval pathway. Unfortunately, it appears you may have been misinformed, as your answers to key questions were either incorrect or lacked important context. 

During a hearing held by the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education, and Relations Agencies, you said: 

“…the clinical trials have not been done in this particular case. This was an accelerated approval...FDA is still requiring that the manufacturer of the drug provide clinical evidence that it works. They went ahead and gave conditional approval, but they're still waiting to get the evidence from clinical trials, and that's where CMS is saying, that's the kind of information we need, the clinical trials showing success…” 

Contrary to your statement that “clinical trials have not been done,” results from Leqembi’s phase III confirmatory trial were published on November 29, 2022, in the New England Journal of Medicine,i making them publicly available for more than four months. 

In response to the same question, you said the FDA requires the manufacturer to provide “clinical evidence that [Leqembi] works,” and that CMS needs to see “clinical trials showing success...” Analysis completed by a range of experts shows that Leqembi provides clear clinical benefit for people living with AD. According to an open statement signed by 200 scientists, physicians, and AD experts, “The results…suggest that over the course of the 18-month trial, those on lecanemab progressed almost 6 months slower than those on placebo. Treatments like lecanemab hold the promise of improving the quality of life of our patients and their families experiencing AD.”ii 

What is more, in response to a statement from one member of the Subcommittee, you said “CMS has to remain consistent in the way it treats any drugs.” Mr. Secretary, people living with AD and their families only wish CMS would treat Leqembi the way it treats other drugs. 

Rather than evaluate evidence on individual Alzheimer’s medicines, the coverage with evidence development (CED) decision CMS issued on April 7, 2022, applies to the entire class of monoclonal antibodies directed against amyloid for use in treating AD (mAbs).iii This is the first time – ever – CMS has made an entire class of drugs subject to a CED. The CMS decision means the CED applies to drugs for which clinical trial data does not yet exist. 

This refusal to cover is not based on any analysis of Leqembi data but is rooted in a decision CMS made on a different drug, before ever seeing Leqembi data. That is not consistent with how CMS has ever treated any other drug for any other disease, and it causes many people living with AD and their families to ask why CMS is treating them differently. Each drug must be evaluated on its own data, not on the data of another drug. 

These misstatements and others you made during these hearings could leave many people with the wrong impression of the CMS decision to not cover Leqembi and any future mAbs. I urge you to correct the record so lawmakers and the public have an accurate assessment of these important issues, and to direct CMS to, in fact, “remain consistent in the way it treats any drugs.”

Sincerely, 

George Vradenburg 
Co-Founder and Chairman 
UsAgainstAlzheimer’s 

cc: Members of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

i “Lecanemab in Early Alzheimer’s Disease,” New England Journal of Medicine, November 29, 2022, https://www.nejm.org/doi/full/10.1056/NEJMoa2212948 
ii “Treating Alzheimer’s: A New Era Begins with Lecanemab,” https://www.alzforum.org/papers/treating-alzheimers-new-era-begins-lecanemab 
iii “CMS Finalizes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease,” April 7, 2022, cms.gov.

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 About UsAgainstAlzheimer’s
UsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and access to treatments – all regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.