After Medicare rejection, Eisai and Biogen's Leqembi gets thumbs-up from Veterans Administration

Less than three weeks after Medicare said no to providing wider coverage of Eisai and Biogen’s Alzheimer’s drug Leqembi, the United States Veterans Health Administration (VHA) has ruled that it will cover the treatment, allowing access to veterans with an early stage of the disease.

The decision of the agency—which was announced by the companies on Monday—was a pleasant surprise for the drugmakers after last month's defeat when The Centers for Medicare and Medicaid (CMS) rejected a petition, leaving in place a restrictive policy for an entire class of amyloid Alzeihmer’s drugs, including Leqembi and its predecessor Aduhelm.

“This is an important step toward access to medically necessary and beneficial treatments for people living with mild cognitive impairment,” Joanne Pike, CEO and president of the Alzheimer's Association, said in a release. “Each day matters to someone living with early-stage Alzheimer's when it comes to slowing the progression of this disease.”

Approved under the FDA’s accelerated pathway two months ago, Leqembi costs $26,000 annually. The drug, which is infused twice a month, targets brain plaque.

The FDA has set a target date of July 6 to decide whether to grant Leqembi a full approval. If it passes muster, Medicare officials would then deliberate over the agency's coverage policies.

"We see the VHA decision as the beginning of a potential series of wins on the reimbursement front for Leqembi, with the larger catalyst being the CMS potentially revisiting the currently restrictive (national coverage determination) after full approval," Myles Minter, Ph.D., an analyst with William Blair, wrote in a note to investors.

A late-stage trial showed Leqembi slowed cognitive decline by 27%. Possible side effects include brain swelling and bleeding, with those taking blood thinners more susceptible.

The VHA will cover veterans with an early stage of Alzheimer’s who meet a set of criteria. They must be over age 65, have undergone an MRI within the last year and have an elevated level of brain amyloid.

"Not all veterans living with Alzheimer's will be eligible for treatment, but unlocking reimbursement for these beneficiaries puts Eisai well on course to identify 100,000 patients eligible for treatment by 2026," Minter added.

William Blair estimates the total addressable market in the VHA patient population alone is greater than $2.5 billion and growing to $3.2 billion by 2033. The analysts project overall sales of Leqembi in the U.S. reaching $4.6 billion in 2030.

When the VHA was faced with a similar decision on Aduhelm in August of 2021, it decided not to place the drug on the national formulary. At the time, Aduhelm cost $56,000 per year. The agency cited a lack of evidence of “clinical benefit.”

The VHA serves nine million veterans at 1,300 facilities nationwide, according to its website. The VHA estimates that 168,000 veterans had Alzheimer’s in 2022.

The rejection last month from Medicare came in response to a request by the Alzheimer’s Association to change its policy for Leqembi. It also came shortly after the American Academy of Neurology threw its support behind Leqembi and after lawmakers sent letters urging Department of Health and Human Services and CMS.

In the same statement praising the VHA, the Alzheimer’s Association blasted Medicare, which it said “continues to ignore the needs of their beneficiaries living with Alzheimer's.

“Each day CMS blocks access to treatment, more than 2,000 individuals aged 65 or older transition from mild dementia due to Alzheimer's to a more advanced stage of the disease where they are no longer eligible. Treatments taken in the early stages of Alzheimer's would allow people more time to participate in daily life, remain independent and make health care decisions for their future.”