Close-up of American Dollar banknotes with stethoscope

Medicare costs could rise by $2 to $5 billion a year if the Centers for Medicare & Medicaid Services expands its coverage for newly approved Alzheimer’s disease drug Leqembi (lecanemab), according to the authors of a new study.

Leqembi, made by Eisai and Biogen, targets amyloid brain plaques linked to Alzheimer’s symptoms and has been shown to modestly reduce decline in cognition and function. The treatment received accelerated approval by the Food and Drug Administration in January, and its current coverage is limited to use in clinical trials. 

CMS, under pressure from patient advocates and lawmakers, has said it may reconsider its coverage stance if Leqembi or other drugs in its class are greenlit under traditional approval pathways. Currently, donanemab, another drug in the class, is on a path to traditional approval.

Skyrocketing Medicare, out-of-pocket costs

To estimate the potential effect of broadened coverage, investigators performed a cost analysis using nationally representative survey data from the 2018 Health and Retirement Study. They found that lecanemab’s proposed yearly cost of $26,500, plus an estimated 28% in additional related spending per patient, would send Medicare costs skyrocketing.

Expanded coverage could also lead to substantial out-of-pocket costs for beneficiaries lacking supplemental coverage, they added.

If approximately 85,600 eligible patients received lecanemab, Medicare would spend $2 billion annually, the researchers estimated. When the patient number was raised to about 216,000, the amount Medicare would spend increased to $5.1 billion annually. Annual per-patient coinsurance could reach an estimated $6,636, they added.

A conservative estimate

Although investigators factored in projected increases in cognitive screening and diagnoses, they said their estimates are conservative. “Changes in physician behavior, cognitive screening capacity and demand, new diagnoses of mild cognitive impairment or mild dementia, and associated spending may increase more than anticipated,” they concluded.

Full findings were published in JAMA Internal Medicine.

Related article:

Eli Lilly expects Medicare about-face on Alzheimer’s drugs coverage

VHA to cover new Alzheimer’s drug Leqembi, despite CMS’s restraint

Patient advocates decry CMS decision to stand by its Alzheimer’s drug coverage

CMS restricts coverage of Alzheimer’s drug Aduhelm to clinical trials