With CMS set to announce this week the “maximum fair prices” for 2027’s cohort of drugs under the IRA’s “negotiation” program and the recent the three-year anniversary of that law’s passage, it seemed a good time to take stock of just how the law is influencing the biopharma investors’ and innovators’ collective drug development choices. A collection of empirical evidence.

On February 22, CMS announced that they would not be reconsidering the National Coverage Determination (NCD) that effectively denies Medicare patients access to lecanemab, a drug with accelerated approval for Alzheimer’s disease. CMS’s rationale was that “there is not yet evidence meeting the criteria for reconsideration.” It’s worth pausing to consider the highly unusual CMS precedent that is playing out in Alzheimer’s.