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FDA Approves New Alzheimer’s Treatment As Medicare Delays Access

This week, the FDA approved a new Alzheimer’s treatment that helped people live independently for five months longer on average and continue to perform the tasks of daily life. Unfortunately, few will benefit because of Medicare’s restrictive coverage. People with symptoms of mild dementia can only get access by enrolling in a registry and participating in new clinical trials.

Writing in the Chicago Tribune, Dr. Raymond Turner, explains how this additional burden on doctors and patients will cause delays and continue to limit access to the new treatment:

As a young physician in training, I became focused on the search for Alzheimer’s treatments because the disease was, and remains, America’s largest single unmet medical need. Alzheimer’s is a tragic dehumanizing illness, resulting in death by inches. When I graduated from medical school, new transgenic mouse models of the disease were being developed. It was an exciting time, and researchers and clinicians worked to translate many successful treatments of mice to human patients. That 20-year effort has been fraught with disappointment — until now.

After more than 150 failed clinical trials, the success of lecanemab in removing amyloid plaques from the brain, the cause of Alzheimer’s, is what we have been waiting for. The treatment helped patients remain independent and perform tasks of daily life for five months longer during an 18-month study published in the New England Journal of Medicine. Yet now, in what should be a breakthrough moment for our patients and families, CMS is operating with a different set of rules.

…Our patients and their families want to know: How long will it be before they can access the new medicine? Patients with early Alzheimer’s disease who are candidates for treatment may advance to the moderate stage before the treatment is available, thus missing their window of opportunity.

If the FDA approved a new treatment for, say, cancer or HIV/AIDS with similar risks and benefits, Medicare would quickly provide coverage with no need for a registry or additional trials. The differential ruling for Alzheimer’s treatments may belie a bias against the elderly — ageism, perhaps.

The American Academy of Neurology and leading Alzheimer’s patient advocacy groups have called for CMS to reconsider its coverage policy. The agency can host a transparent discussion with a broader group of stakeholders to address concerns and establish a balanced way forward that best serves patients. For now, these decisions are being made opaquely with little input from those close to the disease.

The hope I had as a young physician in training is now being realized. New discoveries are leading to medical breakthroughs that can effectively diagnose, treat and perhaps one day even prevent Alzheimer’s and other neurodegenerative dementias of aging. Making these tools available to address our greatest unmet medical need should be a national priority.

Dr. Turner is a leading light in Alzheimer’s care. He serves as vice chair for clinical research, professor of neurology and director of the Memory Disorders Program at MedStar Georgetown University Hospital, and he runs clinical trials for many treatments to address Alzheimer’s and other neurodegenerative diseases. You can read his article in full here.