The VA has announced that it will cover Leqembi, a monoclonal antibody therapy made by pharmaceutical companies Eisai and Biogen, for veterans in the disease’s early stages. This makes the VA the first and largest health program in the country to endorse the treatment, reports’ military.com in its recent article entitled, “VA to Cover New Drug for Early Stage Alzheimer’s Disease.”
In January, the FDA granted accelerated approval for Leqembi, also known as lecanemab, when research showed that the medication slowed the physical and mental decline in some patients with early Alzheimer’s by as much as 27%. Although research is ongoing on the treatment’s effectiveness, the drug is among the first to show that it reduces beta amyloid — the toxic protein that contributes to the development of Alzheimer’s — in the brain.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease,” said Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, during the accelerated approval announcement.
The VA treats about 168,000 veterans with Alzheimer’s, some of whom are in the early stages. Leqembi has an estimated cost of $26,500 a year, and a two-milliliter dose at the VA will cost the department $194.63. A five-milliliter dose will cost $486.57, according to the department’s National Acquisition Center Contract Catalog.
According to VA Press Secretary Terrence Hayes, the drug will be available only at the request of a provider to vets who “most closely align with” patients who meet the selection criteria for clinical trials. This means that the VA patients must meet the same demographic and health history standards as those studied by the manufacturers.
“Each dose of the medication administered for each patient will be tracked and monitored for safety and appropriateness of use, in real-time, by VA’s Center for Medication Safety,” Hayes said in an email to Military.com. “VA will continue to monitor the clinical evidence and safety data for this agent and adjust the criteria for use as appropriate. VA also has capabilities and safeguards in place that are very different from the private sector, such as the ability to conduct real-time medication-use evaluations that will allow for continued safe use of the medication.”
Leqembi is approved for use only in patients with early Alzheimer’s with a “confirmed presence,” via a brain scan, of beta amyloid.
Reference: military.com (March 14, 2023) “VA to Cover New Drug for Early Stage Alzheimer’s Disease”