CMS Rejects Coverage for FDA-Approved Alzheimer’s Drug Except for Research: Evidence that the Federal Payer Doesn’t Trust FDA Judgment?

CMS Rejects Coverage for FDA-Approved Alzheimer’s Drug Except for Research: Evidence that the Federal Payer Doesn’t Trust FDA Judgment?

Imagine your loved one has Alzheimer’s disease (AD), and for the first time in twenty years, a new treatment is approved. You go to the doctor to secure a prescription and access the drug in the hopes of making it better, only to find out it cannot be prescribed in a care environment; your loved one has to access the new drug only through a clinical trial. And of course, there are only a few, if any, clinical trials easily accessible. Access is limited; candidate requirements are now in place, and you must start searching all over again. That is the reality for over 6 million Alzheimer’s patients in America, since the U.S. government’s Centers for Medicare and Medicaid Services (CMS) on Tuesday announced it plans to cover Alzheimer's treatments, including Biogen Inc's (BIIB.O) Aduhelm, but will require patients to be enrolled in a clinical trial. Given the U.S. Food and Drug Administration (FDA) approved the drug, shouldn’t such an important drug be available to all those in need? Isn’t that why the FDA approved the drug in an accelerated manner? But maybe that’s the problem. Perhaps CMS doesn't trust FDA’s judgment anymore.  Perhaps CMS concluded that A) it’s unclear how the drug...

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