The Veterans Health Administration will provide coverage for the recently approved drug lecanemab (Leqembi) to qualified veterans with early Alzheimer’s disease, its maker Eisai announced Monday.
The surprise announcement comes after the Centers for Medicare & Medicaid Services in February said it was not ready to reconsider its highly restrictive Medicare coverage of drugs in this class.
The VHA will consider potential candidates for Leqembi treatment if they fit the VHA’s criteria for use and the parameters of Food and Drug Administration’s (FDA) current drug label, Eisai said in a statement.
“The VHA’s careful consideration and timely action to make Leqembi available … shows its continued commitment to veterans living with AD,” the drugmaker said.
Leqembi was approved for use in January for patients with early Alzheimer’s disease. The drug and its predecessor Aduhelm are monoclonal antibodies that target Alzheimer’s brain plaques and were granted fast-tracked approvals based on demonstrated need. Clinical trial data showed that treatment with Leqembi slowed measures of cognition and function by approximately 27% over an 18-month period when compared with a placebo group.
Last year, CMS confined coverage of Biogen’s new drug aducanumab (Aduhelm) and any future drugs in the class to clinical trial participants only, citing concerns about the availability of safety and efficacy data, among other issues. Aduhelm’s costs to Medicare were controversial as well.
CMS has said it may reconsider its coverage stance based on additional clinical trial data, and/or if the FDA later approves such a drug using traditional pathways. Along those lines, Eisai last week was granted priority review of its request to convert the accelerated approval of Leqembi to a traditional approval, potentially setting it up for CMS reconsideration. That could lead to a greater patient access beyond veterans and clinical trial participants. The review is scheduled for July 6.
The Alzheimer’s Association praised the VHA’s action. “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,” Joanne Pike, DrPH, Alzheimer’s Association president and CEO, said in a statement.
The organization and other patient advocacy groups have been vocal critics of CMS’s current coverage stance.
Related articles:
FDA approves new drug Leqembi to treat early Alzheimer’s disease
Patient advocates decry CMS decision on Alzheimer’s drug coverage
Alzheimer’s drug lecanemab (Leqembi) has ‘moderate’ effect on cognitive decline, trial data show
CMS restricts coverage of Alzheimer’s drug Aduhelm to clinical trials
