Overview of issues

The Veterans’ Health Administration and the Centers for Medicare and Medicaid Services (CMS) have a legal mandate to provide for the healthcare needs of their respective constituencies. The FDA has a mandated to look into the efficacy and safety of treatments and drugs. 

The FDA approved a new Alzheimer’s treatment, Leqembi, under a legal and data-driven accelerated approval process.

The VA approved coverage of Leqembi for roughly 168,000 U.S. veterans with Alzheimer’s who qualify for treatment under clear guidelines.

CMS has denied coverage for 1.2 million elderly Americans who are living with Alzheimer’s and are depending on CMS to pay for life-improving treatments.

The VA is right. CMS is wrong.

Broad, bipartisan opposition to CMS is growing

More than 70 bipartisan House lawmakers and 18 senators, more than two dozen attorneys general, and thousands of Alzheimer’s advocates, caregivers, physicians, researchers and patients have urged CMS to provide people living with Alzheimer’s equitable access to approved treatments.

Why? CMS’s unprecedented, immorally restrictive policy leaves behind underserved and socioeconomically disadvantaged Americans, as well as those in rural areas. 

By CMS’ rule, the only people who can access medication are those who live near big research centers where they can enroll in a randomized clinical trial and pray that they get the treatment and not a placebo.

CMS’ National Coverage Determination (NCD) goes from treating, and covering, up to 1.2 million people to a few thousand (UsAgainstAlzheimer’s).

GAP calls on CMS to full cover all FDA-approved Alzheimer’s treatments and medications.

The current CMS policy preventing access to FDA-approved Alzheimer’s treatments is ageist. 

And it’s racist…Alzheimer’s hits people of color harder than other ethnicities.

It is immoral to deny access to life-changing therapy to the more than 1 million seniors with Alzheimer’s disease, and yet that is exactly what CMS is doing.

For people living with Alzheimer’s, access to FDA-approved drugs equals more time with friends and family, more independence, more life as they know it today.

CMS’ discriminatory payer tactics must not be allowed to continue. This is an imbalance in power – the FDA approved the drug, so CMS should approve it.

Anyone who knows the progressive nature of Alzheimer’s knows that time is of the essence. With the disease, time, memory and life is lost without the ability to treat the disease. CMS must reverse course on its harmful national coverage decision immediately.

· In essence, CMS is rationing care. Today it’s Alzheimer’s drugs. Tomorrow it could be…???

Centers for Medicare and Medicaid Services: 

· The Centers for Medicare and Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program, among others.

· In April, 2022, CMS made an unprecedented decision to deny coverage of FDA-approved treatments that target amyloid for Alzheimer’s disease for their beneficiaries living with Alzheimer’s disease.  This includes approved treatments aducanumab (Aduhelm) and lecanemab (Leqembi).

· CMS provides critical Medicare health coverage (payment) to over 65 million seniors in the United states including an estimated 1.2 million people living with Alzheimer’s disease. 

The Department of Veterans Affairs:

· The Department of Veterans Affairs (VA), via their sub-cabinet level agency the Veterans Health Administration provides health care services to millions of veterans, including over 168,000 living with Alzheimer’s. .  They are considered a “sister entity” to CMS – demonstrated enormous leadership and concern for the health of veterans fighting Alzheimer’s disease with its recent decision to cover the cost of Leqembi.

· We applaud the VA for its decision to cover Leqembi for veterans in early stages of Alzheimer’s.

· This was a much-deserved victory for the veterans who have Alzheimer’s and receive services through the VA.

About the Global Alzheimer’s Platform Foundation (GAP):

GAP is a patient-centric, non-profit organization dedicated to speeding the delivery of innovative therapies to those living with Alzheimer’s and other neurodegenerative diseases by reducing the time and cost of clinical trials. At GAP, we have seen what Alzheimer’s disease does to people living with it and the deep sadness when someone cannot access or continue a treatment. With a network of over 90 clinical trial sites across North America that benefit from sharing knowledge and experience to effectively and efficiently work toward research progress in neurodegenerative conditions, we know the commitment that clinical trials require – from volunteers, from doctors, from clinical site staff.

We know the commitment that clinical trials require – from volunteers, from doctors, from clinical site staff.