The voices of individuals with Alzheimer’s and their families have turned the tide!  

Washington, DC, July 7, 2023 – Voices of Alzheimer’s, an advocacy organization led by people with lived experience with Alzheimer’s, join others in celebrating the U.S. Food and Drug Administration’s (FDA) decision to grant the first-ever traditional approval of a disease-modifying therapy for Alzheimer’s disease. This news is a historic step forward for people living with Alzheimer’s and their families, who now finally have treatment that can slow the onset of the disease, extend independence, and improve quality of life. 

Leqembi initially received Accelerated Approval from the FDA in January of this year after clinical trial research showed a slowing of cognitive and functional decline for people with mild cognitive impairment at the early stage of the disease, equating to potentially months or even years of added time engaging with loved ones and living independently for people living with Alzheimer’s. After decades of failed attempts at developing treatments, Leqembi’s traditional approval represents hope for millions across the country affected by Alzheimer’s disease. 

While we celebrate these historic steps forward, Voices of Alzheimer’s will continue to fight to ensure that people living with Alzheimer’s have affordable access to the diagnostics and treatments necessary to combat this disease. We remain committed to calling out inequities surrounding the Centers for Medicare and Medicaid Services (CMS) treatment of individuals living with Alzheimer’s. 

Voices of Alzheimer’s is monitoring the ongoing position of The Centers for Medicare and Medicaid Services (CMS) thus far claiming to provide broad access to Leqembi through Medicare now that the treatment has received FDA traditional approval. We will hold the agency to its promise to ensure that any Medicare beneficiary medically eligible for Leqembi can access the treatment. 

Our Voices of Alzheimer’s members will continue to press Medicare to ensure it keeps its word in ensuring that its registry requirements are not burdensome to patients and do not hinder access to treatment. Immediate, no-cost access to the registry, accessible reporting and prescribing requirements, and no exclusion of specific subgroups from receiving the medication appear to be positive steps forward, and CMS should do all it can to ensure its registry requirements do not hinder access to treatment. 

 It also remains true that Medicare should never have required a registry for Leqembi in the first place, as CMS has never before required a registry for a traditionally approved treatment or issued a National Coverage Determination for an entire class of drugs. The FDA’s rigorous approval process ensures that by the time CMS makes a coverage determination, evidence for the on-label use of a drug is proven. No matter how it is implemented, a registry is unnecessary and sets a dangerous precedent for access to future treatments for Alzheimer’s and all other conditions. 

Even as CMS takes a step forward in providing broad coverage of Leqembi, we are still gravely concerned that CMS refuses to cover the cost of diagnostic tools like amyloid PET scans for people living with Alzheimer’s disease. Access to diagnostics is key to ensuring the early detection of Alzheimer’s, which is the only stage of the disease addressed by existing disease-modifying treatments. Lack of coverage for diagnostics by CMS prevents people from learning they have Alzheimer’s during a stage of the disease when treatments may help them. 

Jim Taylor, President of Voices of Alzheimer’s and a long-time care partner, said, “The decision by the FDA to grant traditional approval for Leqembi is a monumental step forward for the Alzheimer’s community. For so long, people living with the condition have been left hopeless, with no options for treatment. This approval is a hard-fought victory for millions of people living with Alzheimer’s and their families, who now have hope that we are moving toward a future free from this terrible disease.” 

Taylor added, “While we celebrate today, there is still more to do to ensure those affected by Alzheimer’s have access to the diagnostics and treatments they need. Medicare needs to cover diagnostics for Alzheimer’s to continue driving the early detection so crucial in treating the disease and must stay true to their promise of providing broad coverage of FDA approved therapies.” 

“The unity of the Alzheimer’s community in demanding broad access to breakthrough FDA approved treatment has been inspiring.  We are extremely grateful for all those with Alzheimer’s and families who have raised their voice, our sister organizations who have also demanded full access, and for Congressional support in making their voices heard by objecting to any restrictions CMS might initiate to ration care.”   

Every day, up to 3,200 Americans progress from mild to moderate Alzheimer’s disease, where new treatments may no longer help them. Traditional approval of Leqembi is a historic step forward in helping these individuals before progressing to the moderate stage of the disease. We continue to call on Medicare to ensure that treatments are available to those who need them and that the costs of the tools necessary to diagnose Alzheimer’s are covered. 

### 

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