Positive results from an Alzheimer’s trial by Eli Lilly are seen as a very important step in the battle to fight the fatal disease, but questions remain about whether it will be covered by Medicare.
Eli Lilly’s
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positive Phase 3 trial showed that the drug donanemab “significantly slowed cognitive and functional decline” in patients with early symptomatic Alzheimer’s disease, and met its primary and secondary goals.
“The news about donanemab potentially slowing cognitive decline for Alzheimer’s disease patients is interesting and potentially very important,” Constantine Lyketsos, professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine. “We are looking forward to more details and further studies to determine how effective this drug may be.”
Read: Eli Lilly stock jumps 8% after Alzheimer’s treatment slows disease progression in major trial
The Alzheimer’s Association applauded the news, saying the results were the strongest Phase 3 data for an Alzheimer’s treatment to date. More than 6 million Americans are living with Alzheimer’s, and the number is projected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association.
Lilly’s news about donanemab comes on the heels of two other Alzheimer’s drugs that hit recent roadblocks. Earlier this year, Medicare said it wouldn’t provide broad coverage of Leqembi, an Alzheimer’s drug developed by Biogen
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and Eisai
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without more evidence of effectiveness and potential health risks before approving payment for the drug. And then there was Aduhelm (also developed by Biogen and Eisai), which was approved by the FDA two years ago, and was dogged by efficacy concerns, safety issues and high costs.
The positive donanemab trial “further underscores the inflection point we are at for the Alzheimer’s field. The progress we’ve seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease,” said Maria Carrillo, Alzheimer’s Association chief science officer. “Yet, Medicare stubbornly continues to block access for the people who could benefit.”
Eli Lilly plans to proceed with global regulatory submissions as quickly as possible and expects to make a submission to the U.S. Food and Drug Administration this quarter.
“These donanemab Phase 3 results are significant and further underscore the scientific evidence and personal benefit these types of treatments can have when people can get access to them. The Centers for Medicare and Medicaid Services policy to block Medicare access to Food and Drug Administration-approved Alzheimer’s treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” said Joanne Pike, Alzheimer’s Association president and chief executive.
Eli Lilly also said that nearly half (47%) of the study participants taking donanemab had no decline of cognition and function for one year (compared with 29% on placebo). Donanemab slowed clinical decline by 35% compared with placebo on the primary outcome measure and resulted in 40% less decline in the ability to perform activities of daily living.
For people in the earliest stages of Alzheimer’s, these results suggest donanemab will significantly change the course of the disease. These results indicate donanemab gives people more time at or near their full abilities to participate in daily life, remain independent and make future healthcare decisions, the Alzheimer’s Association said.
“Treatments that deliver these benefits are just as valuable as treatments that extend the lives of those with other diseases,” the Alzheimer’s Association said.
However, the monthly antibody infusion has risks. Donanemab can cause temporary brain swelling and bleeding. Three participants died of those side effects, Eli Lilly said.
Keith Vossel, center director of the Mary S. Easton Center for Alzheimer’s Research and Care, said the trial was “really groundbreaking to slow the course of the disease progression. We can build on that and develop treatments given in a safer manner. But there are obstacles getting this medication out to the general population.”
Vossel pointed out that in addition to the cost of the treatment itself, which is unknown, there are a lot of ancillary costs related to brain imaging that make it “a sticky problem for how widely this will be available.”
He said it was too early to guess on what decision CMS may make.
Since April 2022, the Centers for Medicare and Medicaid Services, or CMS, has denied access to FDA-approved Alzheimer’s treatments through a National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. This NCD would also apply to donanemab if it is approved for use by the FDA.
Read: Why won’t Medicare cover the new Alzheimer’s drug?
“CMS has repeatedly pledged to move quickly to modify the NCD if warranted by new evidence—yet they have failed to do so to date. Today’s topline data is further evidence that this class of treatments can provide a meaningful benefit to people living with early Alzheimer’s. We urge CMS to immediately review existing data just as the U.S. Veterans Health Administration did,” the Alzheimer’s Association said.
CMS did not immediately respond to a request for comment.
Read: How the Alzheimer’s drug Aduhelm posed a real challenge to Medicare officials
Eli Lilly is expected to provide more details on this positive TRAILBLAZER-ALZ2 trial at the Alzheimer’s Association International Conference (AAIC) in July, including data on participant safety and representation.
“If those data are consistent with what we saw today regarding efficacy and safety, we strongly support FDA approval and, if approved, we expect CMS and other private insurance coverage,” said Carrillo.
This post was originally published on Market Watch
