The CMS Aduhelm Decision: Why It Was Dead On
I adore The Wall Street Journal and often agree with its politics, but the editorial that led the Journal’s editorial page, Review & Outlook, on Monday January 24 misses the mark completely.
The Journal calls the Centers for Medicare and Medicaid Services (CMS) a “death panel” for being unwilling to pay for a new class of Alzheimer’s drug that was given accelerated approval by the FDA recently despite the advisory board’s recommendation not to do so. While it may be true that these new agents like Aduhelm decrease the amyloid in the brains of people with Alzheimer’s, they have not been conclusively shown to alter the course of the disease or the decline in cognitive function of its victims. Thus, CMS will pay for the drug IF the recipient is on a clinical trial—one that is randomized between drug and placebo. This is exactly as should be the case with a drug given accelerated approval. That approval basically says we need more data to know if this really works, but since it might and the target disease is one desperately needing treatment, a randomized, placebo-controlled trial is the best way to do it.