WASHINGTON, D.C. – U.S. Senators Senator Shelley Moore Capito (R-W.Va.) and Susan Collins (R-Maine) led a bipartisan group of 20 Senators in sending a letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to expand Alzheimer’s patients’ access to treatments. The letter calls on CMS to reconsider the Coverage with Evidence Development (CED) requirements for Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease.

On January 6, 2023, FDA granted accelerated approval of Leqembi (lecanemab) for the treatment of patients in mild cognitive impairment or mild dementia stage of Alzheimer’s disease and with confirmation of amyloid beta. Under the national coverage determination (NCD) currently in place, however, CMS will only cover monoclonal antibodies treating Alzheimer’s and other dementia approved through the accelerated approval pathway for individuals enrolled in randomized clinical trials and treatments approved through the traditional approval pathway when patients are enrolled in prospective comparative studies. Unless CMS reconsiders the April 2022 NCD, access to lecanemab and other disease-modifying therapies for Alzheimer’s disease will be extremely limited.

“Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient,” the senators wrote. “Processes that may delay coverage decisions by several months can impose significant access delays, resulting in irreversible disease progression and added burdens for caregivers and loved ones. Based on projections from the Alzheimer’s Association, more than 2,000 individuals aged 65 or older transition per day from mild dementia due to Alzheimer’s disease to moderate dementia due to Alzheimer’s disease, and therefore outside the anticipated indicated population of lecanemab.”

“This overdue CMS action will ensure Medicare beneficiaries living with mild cognitive impairment due to Alzheimer’s disease and early stage Alzheimer’s disease have immediate access to FDA-approved treatments if the patient and clinician decide it is right for them,” the senators concluded.

This effort is supported by the Alzheimer’s Association.

“Thank you to Senators Susan Collins and Shelley Moore Capito for leading this bipartisan effort to ensure access to FDA-approved Alzheimer’s treatments,” Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director, said. “CMS is blocking people living with early stage Alzheimer’s from accessing FDA-approved Alzheimer’s treatments. Each day without access to and coverage of treatment, these individuals are losing memories, skills and, most importantly, time with their loved ones.  We are grateful to those on both sides of the aisle for signing onto the letter and for your support of the Alzheimer’s community.”

BACKGROUND:

By 2050, nearly 13 million Americans are projected to live with Alzheimer’s disease. In West Virginia alone, it is expected that 44,000 individuals will be living with Alzheimer’s by 2025, and over 830 individuals will lose their life to the disease each year. In 2022 alone, Alzheimer’s and other dementia will cost the nation $321 billion. Medicare and Medicaid bear much of this financial weight, as the programs are expected to cover about $239 billion, or 67%, of these costs in 2021. Unless a treatment to slow, stop, or prevent the disease is approved and accessible to people, Alzheimer’s is projected to reach a total cost of $1 trillion by 2050.

In addition to Senators Capito and Collins, the letter was signed by: U.S. Senators John Barrasso (R-Wyo.), James Lankford (R-Okla.), Jerry Moran (R-Kan.), Kevin Cramer (R-N.D.), Ted Budd (R-N.C.), Markwayne Mullin (R-Okla.), Marco Rubio (R-Fla.), Cynthia Lummis (R-Wyo.), Lisa Murkowski (R-Alaska), Gary Peters (D-Mich.), Roger Wicker (R-Miss.), Deb Fischer (R-Neb.), Cindy Hyde-Smith (R-Miss.), Thom Tillis (R-N.C.), Amy Klobuchar (D-Minn.), John Hoeven (R-N.D.), Mike Rounds (R-S.D.), and John Boozman (R-Ark.).

Full text of the letter is available here.

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