Washington, DC, January 6, 2023 – Voices of Alzheimer’s, an advocacy organization led by people with lived experience with Alzheimer’s, today welcomed the decision by the U.S. Food and Drug Administration to approve the second-ever disease modifying treatment for early-stage Alzheimer’s and said the approval must refocus attention on Medicare’s discriminatory decision last year to block coverage for innovative treatments for people living with Alzheimer’s.

The FDA this afternoon granted expedited approval to Lecanemab, a drug developed by Eisai and Biogen, which has demonstrated positive results in slowing Alzheimer’s. The FDA is expected to give full approval to Lecanemab later this year.

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.

The company’s clinical trials enrolled 1,795 people with early Alzheimer’s who had evidence of the amyloid brain plaques believed to contribute to cognitive decline.

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. As to safety, Dr. Sharon Cohen, a member of the VOA scientific advisory committee, asserted that the drug’s safety profile is “reasonable with low risks.”

“Once again,” Dr. Cohen added, “some are trying to hold Alzheimer’s treatments to a higher standard than with other therapeutic areas.”

Jim Taylor, President of Voices of Alzheimer’s and long-time care partner, said that “The FDA’s decision represents a milestone moment in the search for an effective treatment for Alzheimer’s.”

These results, Taylor added, 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.

Last year’s decision by Medicare to severely limit coverage for anti-amyloid drugs was unprecedented. Experts say they can think of no other class of drugs that has been treated in such a way by Medicare.

Rebecca Chopp, a founding Board member of Voices of Alzheimer’s, is living with early Alzheimer’s. “We have waited long enough,” she 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,” she added.

Learn more on the Voices of Alzheimer’s website, and on social media through Facebook, Twitter, Instagram, and TikTok.

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