VHA to Cover Eisai, Biogen’s Alzheimer’s Drug for Eligible Veterans

The Alzheimer's drug Leqembi is seen in an undated handout image obtained on Jan. 20, 2023. Eisai/Handout via Reuters

The Veterans Health Administration (VHA) will provide coverage for Japanese company Eisai Co., Ltd and Biogen’s Alzheimer’s treatment Leqembi to eligible veterans living with early stages of Alzheimer’s disease, the companies announced on March 13.

In order to be eligible for the drug, veterans will need to meet certain VHA criteria (pdf), such as having undergone an MRI scan within the last 12 months, and being over 65 years of age, among others.

Leqembi, known chemically as Lecanemab, was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on Jan. 6, 2023, for the treatment of Alzheimer’s disease, which is irreversible.

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That accelerated approval allows it to be marketed before it is fully proven to be effective.

The drug is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody designed to target the disease via beta-amyloid protein plaques, sticky clumps of a toxic protein that build up in the brain during Alzheimer’s and which experts believe could be a contributor to Alzheimer’s.

It is administered through an intravenous injection every two weeks.

An 18-month study involving participants experiencing the early stage of Alzheimer’s showed that Leqembi slowed cognitive decline by 27 percent compared with a placebo.

Leqembi Side Effects

However, the drug carries potential side effects including bleeding in or on the surface of the brain, swelling and headaches, confusion, dizziness, vision changes, and nausea.

Individuals with untreated blood disorders, low serum vitamin B12 levels, and untreated human immunodeficiency virus (HIV), among other health issues, do not meet the criteria to be eligible for the drug.

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Additionally, individuals with certain health factors, such as those taking blood thinners, may be at a higher risk of adverse effects like cerebral macro hemorrhage (bleeding within the brain).

Monday’s announcement comes after the Centers for Medicare and Medicaid (CMS) rejected a request from the Alzheimer’s Association to provide wider coverage of FDA-approved monoclonal antibodies for the treatment of Alzheimer’s disease, except in limited clinical trials.

“After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,” CMS said.

However, it noted that it would agree to provide broader coverage of Leqembi as soon as it receives full FDA approval.

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The FDA has set a deadline of July 6, 2023, to make a decision regarding full approval of the drug.

An estimated 167,954 veterans receiving care through the VHA have Alzheimer’s dementia, according to government estimates, although it is not clear how many of the veterans meet the criteria for the drug.

‘Important Step Toward Access’

An Eisai spokesperson told Axios the company estimates 80–90 percent of veterans who meet the criteria will be eligible for the treatment.

Leqembi will cost $26,500 per year per patient, according to Eisai and Biogen. At a press conference last week, the companies said they anticipate revenue from worldwide sales of the drug to reach $7.3 billion by 2030.

The Alzheimer’s Association praised Monday’s announcement in a statement, calling it an “important step toward access to medically necessary and beneficial treatments for people living with mild cognitive impairment (MCI) and Alzheimer’s, a fatal disease.”

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“Each day matters to someone living with early stage Alzheimer’s when it comes to slowing the progression of this disease and for our nation’s veterans living with Alzheimer’s, today is a good day,” said Alzheimer’s Association president and CEO Joanne Pike.

“While the Alzheimer’s Association does not agree with all elements of the VHA’s criteria for use, we commend the Biden Administration for this important action today on behalf of veterans living with Alzheimer’s and their families,” the statement added.

Eisai and Biogen also developed the controversial drug Aduhelm, known chemically as Aducanumab.

Aduhelm was granted accelerated approval by the FDA in June 2021 after data from clinical trials showed a reduction in the amyloid-beta plaques of the brain, which “is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”

However, the Medicare program has restricted coverage of Aduhelm, proposing instead that it only be used in clinical trials, which has led to severely limited use of the drug.