In 2011 I lost my father to Alzheimer’s disease, and for years before that, I watched as my parents struggled to navigate their constantly evolving reality that was fraught with heartbreak and nervousness in anticipation of what may happen next.
Alzheimer’s is a progressive and terminal disease that transforms the life of the person with the disease, as well as their surrounding loved ones, and it is an experience my family and I would not wish on anyone. The only thing we wish we had was more time with my father as we knew him best.
Fortunately today, there is at least one FDA-approved monoclonal antibody (mAbs) directed against amyloid for the treatment of Alzheimer’s disease that has proven to slow cognitive decline, allowing for individuals to be able to continue their daily activities for longer. This is a huge step in the right direction for treating Alzheimer’s at its root causes, and not just its symptoms, and is something to celebrate.
But instead of making this treatment as affordable and accessible as possible, the Centers for Medicare and Medicaid Services (CMS) is standing in the way of providing equitable access to this critical – and FDA-approved – treatment.
In an unprecedented decision, CMS placed mAbs into a category called Coverage with Evidence Development (CED), which requires a patient to be enrolled in a clinical trial or registry in order to be reimbursed for the cost of the medication. Such trials have not even been set up by CMS yet, and when they are, the availability will be extremely limited, and even more so for patients living in rural areas. This means that a patient will either have to spend countless hours driving to and from the trial locations – time that should be spent taking care of one’s health – or forgo treatment entirely. It is also well known that a clinical trial requirement is a deterrent for communities of color who may be hesitant to participate.
Placing mAbs into the CED category creates additional barriers to care for patients who do not have extra time to spare. According to the Alzheimer’s Association, more than 2,000 individuals ages 65 and older transition per day from mild dementia due to Alzheimer’s disease to moderate dementia due to Alzheimer’s disease. As someone who has not only lost a father to Alzheimer’s disease, but also served as the former Vice-Chairperson of the Assembly Speaker’s Task Force on Alzheimer’s, I understand just how critical – and finite – this time is for patients and their families.
And across the Badger State, this issue is close to home for many. The number of individuals ages 65 and older who have dementia and live in households – which excludes assisted living facilities – has been increasing and is not projected to slow down, according to the Wisconsin Department of Health Services. In 2010, 94,066 seniors living in households across Wisconsin had dementia and in 2020, that number increased by 21 percent. In 2040, it is anticipated that across the Badger State, 213,238 seniors living in households will be living with dementia – a 127 percent increase from 2010.
CMS must reconsider its national coverage determination for FDA-approved mAbs so seniors on Medicare have access to this critical treatment if it is right for them. And we need leaders in Congress to help us get there. Fortunately, Senator Tammy Baldwin has a proven track record of supporting access to innovative treatments for serious diseases like Alzheimer’s as earlier this year, Senator Baldwin reintroduced the Facilitating Access to Innovative Diagnostics (FIND) Act in Congress.
I encourage Senator Baldwin to continue down the path of equitable access to treatments by urging CMS to reconsider its national coverage determination for FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s. Our seniors do not have time to wait.
