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Impacts Of Fda Approval And Medicare Restriction On Antiamyloid Therapies For Alzheimer’S Disease: Patient Outcomes, Healthcare Costs, And Drug Development, Rouen Brockmann, Joanna Nixon, Bryan L. Love Pharm D., Ismaeel Yunusa Ph. D.

Faculty Publications

In 2021, the US Food and Drug Administration (FDA) granted approval to aducanumab, an antiamyloid antibody for early-stage Alzheimer's disease, despite a lack of clear clinical evidence demonstrating the drug's cognitive benefits. The manufacturer initially priced the drug at a staggering $56,000 per year, a price that was later reduced to $28,200. Unfortunately, these costs do not include the additional expenses associated with monitoring the treatment. However, the Centers for Medicare and Medicaid Services (CMS) recently announced that they will only cover individuals enrolled in clinical trials and will limit coverage of future antiamyloid antibodies. This discrepancy between the FDA …