America’s largest integrated healthcare system, the Veterans Health Administration (VHA), will be providing coverage of LEQEMBI (lecanemab-irmb) “to veterans living with early stages of Alzheimer’s disease,” the producer of the drug, Eisai, announced on Monday.
“VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label,” the release says.
Making LEQEMBI available “approximately two months” after the FDA approved it under the accelerated approval pathway shows VHA’s continued commitment to veterans living with AD.
As Reuters writes, “the drug will be available if patients request it, receive prior approval, and meet strict inclusion criteria.” The initial annual price for LEQEMBI set by the companies is about $26,500.
To qualify for LEQEMBI, per the eligibility criteria for coverage the VHA has set out, patients must be over 65, and have both early-stage symptoms, i.e. mild cognitive impairment (MCI) or mild dementia, as well as amyloid plaques in the brain shown in an MRI scan within the last 12 months.
“While it is difficult to estimate the number of veterans living with the early stages of AD with confirmed elevated amyloid, Eisai estimates that approximately 80-90% of veterans who are eligible for treatment based on the FDA-approved label indication would also fit the criteria for the CFU,” Eisai spokesperson Libby Holman says.
Citing government data, The Wall Street Journal gauges that “167,954 veterans [receive] care through the VHA have Alzheimer’s dementia.”
Two years ago, the VHA refused to include Aduhelm, the Biotechnology Innovation Organization (BIO) members Biogen and Eisai’s other Alzheimer’s drug on its list of approved drugs which would have cost $56,000 a year, justifying its decision with an alleged lack of evidence that the drug was effective as well as safety concerns.