The U.S. Food and Drug Administration has approved a promising medication for the treatment of Alzheimer’s disease but it may be too expensive for many households to afford.
The drug, lacanemab, to be sold as Leqembi, is the second medication approved for Alzheimer’s disease that targets the fundamental pathophysiology of the disease.
At this time, the medication is not covered by Medicare. It is unclear whether private insurers will pay for the drug which is estimated to cost $26,500 per year. Advocacy groups continue to ask for both drugs to be covered by Medicare.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research on Friday. “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.”
Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
Voices of Alzheimer’s, an advocacy organization led by people with lived experience with Alzheimer’s, welcomed the decision by the FDA to approve the treatment for early-stage Alzheimer’s and said the approval must refocus attention on Medicare’s decision to block coverage for innovative treatments for people living with Alzheimer’s.
According to published and peer reviewed research findings, lecanemab has shown a slowing of decline of activities of daily living by 37 percent, a critical indicator of the quality of life of people living with Alzheimer’s and their care partners.
Additionally, clinical trial data showed that lecanemab delayed progression of cognitive loss by 27 percent compared to placebo, which could equate to months or years of benefit to patients in terms of engaging with loved ones and living independently.
Voices of Alzheimer’s said that it continues to be concerned that the price of lecanemab and future breakthrough treatments will negatively impact their accessibility.
“The FDA’s decision represents a milestone moment in the search for an effective treatment for Alzheimer’s,” said Jim Taylor, president of Voices of Alzheimer’s and long-time care partner.
These results, Taylor said, will add pressure on Medicare to reverse its blanket decision last year to refuse to cover the new treatments for Alzheimer’s.
“Based on the FDA’s decision and the new effectiveness data,” he said, “we will demand that the federal government change its discriminatory policies on coverage and allow for access to those who could benefit from the treatment.”
Late last year, the Alzheimer’s Association filed a formal request with the Centers for Medicare and Medicaid Services that it reconsider a blanket decision to require further evidence before approving any of the drugs like lecanemab for coverage by Medicare. Voices of Alzheimer’s strongly supports the association’s request.
Rebecca Chopp, a founding board member of Voices of Alzheimer’s, is living with early Alzheimer’s.
“We have waited long enough,” Chopp said. “We are now seeing the fruits of decades of research into treatment for this disease. We must not allow the government to continue to discriminate against people living with Alzheimer’s by blocking equitable coverage for these new treatments.”
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Crystal Graham
