If you have ever watched a loved one begin showing signs of Alzheimer’s disease, you know how urgent it is to find treatment for this debilitating condition. More than 2,000 people a day in the U.S. progress from mild to moderate Alzheimer’s disease, making access to early and effective treatment a priority for patients and their families. In the last 18 months, patients and their families have been given renewed hope for their ability to access treatment as the Food and Drug Administration approved two new treatments for early stage Alzheimer’s. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) is now erecting roadblocks to prevent timely treatment of the disease for seniors when they need it the most.
Nearly 55,000 people 65 and older in Nevada live with Alzheimer’s disease. Their care, and the care of the 7 million Alzheimer’s patients throughout the country, is currently threatened by a new CMS rule that states that Medicare will not cover the two newest FDA-approved Alzheimer’s treatments used for mild disease unless patients agree to participate in redundant and onerous clinical trials or patient registries. You read that correctly — Medicare will not provide coverage for medications that treat early-stage Alzheimer’s disease unless patients agree to join clinical trials for medications that have already been FDA-approved. This is unprecedented on two counts: No other already-approved medications have been subject to this rule. Perhaps more disturbingly, never before has CMS used its authority to block access to an entire class of new drugs in this fashion.
The Alzheimer’s medications in question have already gone through years-long research to establish their safety and efficacy in treating Alzheimer’s disease. Making patients participate in additional clinical trials as a condition of Medicare coverage is unnecessary and will only serve to delay and, in some cases deny, care for patients who are desperate to keep their disease at bay for as long as possible.
Remember that clinical trials typically require a “control” group of patients who only receive a placebo — an inactive dose — to compare against patients receiving the actual medication. In other words, half of those seeking treatment through this avenue could spend precious time not getting the newest treatment at all. Clinical trials must also sometimes exclude potential participants based on existing medical conditions that would complicate treatment or the progression of their disease.
Some patients would find themselves excluded from trials based on where they live, as those outside of large urban areas do not always have access to clinical trials at their local medical facilities and could be forced to travel long distances for care. Finally, the administrative process to qualify for clinical trials can take months to years. During this time, patients could progress from mild to moderate disease and miss their window for treatment altogether. This burden weighs heavily on the 84,000 Nevadans who serve as family caregivers for Alzheimer’s patients and who must try to navigate through this cumbersome and unnecessary process.
Alzheimer’s disease patients in Nevada and all around the country have a narrow window of opportunity to get treatment for mild disease before it progresses. The last thing patients and their families need when faced with this disease are monetary and administrative barriers to the care their providers decide they need. Recently approved drugs offer a new ray of hope for those who’ve received a terrifying diagnosis. Instead of complicating access to these groundbreaking new therapies, CMS should ensure that our seniors can benefit from the latest FDA-approved treatments.
Lawrence Weiss is the founder and CEO of the Center for Healthy Aging, a nonprofit organization that integrates public, private and philanthropic resources to aid caregivers, enhance wellness and improve the quality of life for seniors. He is the former director of the Sanford Center on Aging at UNR.
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