The Biden administration’s contentious decision to only partially cover Aduhelm could reach well beyond the world of Alzheimer’s drugs, potentially affecting efforts to develop treatments for devastating diseases
But CMS doesn’t stop at requiring novel Alzheimer’s treatments going through the accelerated pathway for approval to undergo further study. Those going through the more intensive, traditional FDA approval process also have to produce more evidence their drugs are effective — sparking outrage among advocates.
The agency action may also chill investments, both in Alzheimer’s drugs that show promise and go through the lengthy, traditional FDA approval process, and in treatments for other difficult diseases. “CMS is showing it has the tool in the toolbox,” he said. “For folks to really change their investment behavior, you’re going to need another example or two going forward.”
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