This NCD would also apply to donanemab if it is approved for use by the FDA.

Since April 2022, 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. Treatments that deliver these benefits are just as valuable as treatments that extend the lives of those with other diseases. Like the other treatments in its class already approved by the FDA, Aduhelm™ and Leqembi™, these results indicate donanemab gives people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. 'Yet, Medicare stubbornly continues to block access for the people who could benefit.'įor people in the earliest stages of Alzheimer's, these results suggest donanemab will significantly change the course of the disease. Carrillo, Ph.D., Alzheimer's Association chief science officer. 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 C. This further underscores the inflection point we are at for the Alzheimer's field. 'These are the strongest phase 3 data for an Alzheimer's treatment to date. Donanemab slowed clinical decline by 35% compared to placebo on the primary outcome measure and resulted in 40% less decline in the ability to perform activities of daily living. Most encouragingly, the company reports that nearly half (47%) of the study participants taking donanemab had no decline of cognition and function for one year (compared to 29% on placebo). The TRAILBLAZER-ALZ2 trial met all of its primary and secondary endpoints. The Centers for Medicare & Medicaid Services (CMS) policy to block Medicare access to Food and Drug Administration (FDA)-approved Alzheimer's treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,' said Joanne Pike, DrPH, Alzheimer's Association president and CEO. '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.

Full readout expected at Alzheimer's Association International Conference in JulyĬHICAGO, On behalf of the millions of Americans impacted by the devastation of Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes the robustly positive topline data reported today by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer's disease.

Association underscores urgent call for CMS to stop blocking access to FDA-approved treatments.

Strongest Alzheimer's Phase 3 data release to date.

Zenith phase