A few weeks ago on Jan. 6 the Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s treatment, lecanemab.
While we know this is not a cure, this is a huge step in the right direction, and this decision is both welcomed and celebrated by the Alzheimer’s Association.
Following the approval of aduhelm, this is the second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.
By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently. This could mean more months of recognizing their spouse, children and grandchildren.
This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.
But the excitement of this news is diminished by an unfortunate reality.
Without insurance and Medicare coverage of this class of treatments, access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket, which comes with a $26,500 annual price tag. Without coverage, people simply won’t be able to get the treatment.
What the Centers for Medicare & Medicaid Services (CMS) is doing by severely restricting coverage for approved treatments is unprecedented and wrong.
The Alzheimer’s Association has submitted a formal request back in December asking CMS to remove the requirement that Medicare beneficiaries be enrolled in a clinical trial in order to receive coverage of disease modifying FDA-approved Alzheimer’s treatments.
Americans living with Alzheimer’s disease are entitled to FDA-approved therapies, just as are people with conditions like cancer, heart disease and HIV/AIDS. And, they deserve the opportunity to assess if an FDA-approved treatment is right for them.
Because of these unprecedented and unnecessary CMS and coverage obstacles, people are losing the opportunity to discuss the opportunity for this treatment with their health care providers and families.
They’re losing days, weeks, months — memories, skills and independence. They’re losing time. And it is unacceptable.
As we move forward into the new year with continued hope for Alzheimer’s research and treatments, including an upcoming accelerated FDA-approval decision for donanemab, we are encouraged by the efforts of our Association and dedicated advocates to ensure a future of accessible treatments for all people.
We are energized at the progress we are seeing in the research pipeline, and we know this is not the time to stop or slow down.
Anti-amyloid approaches, including FDA-approved aducanumab and lecanemab, are likely not a silver bullet, but they are the first wave of effective treatments for Alzheimer’s, with more to come.
We must redouble efforts to discover new targets and test new treatments. The Alzheimer’s Association is committed to advancing all potential treatment avenues, and exploring methods for combining diverse approaches into combination therapies.
Through our committed advocacy network, we have helped secure a seven-fold increase in federal Alzheimer’s and dementia research funding since 2010. Research funding is now more than $3.7 billion annually.
Ultimately, we recognize that individuals face difficult decisions when faced with an unrelenting and fatal disease with no cure. Currently, more than 6 million Amercians are living with Alzheimer’s and over 11 million people are caring for their loved ones.
The safety and well-being of people living with Alzheimer’s disease is our highest priority, and we are urgently working towards our vision of a future without Alzheimer’s and all other dementia.
Lindsey Leonard is the executive director, Alzheimer’s Association California Central Coast Chapter.