capitol hill report: fda approves lecanemab for alzheimer's disease

On July 6, the Food and Drug Administration (FDA) granted traditional approval to lecanemab, brand name leqembi, for the treatment of Alzheimer’s disease (AD). This much anticipated traditional approval will significantly change the availability of the drug that had originally gained accelerated approval in January of this year, as it will now be covered in the context of “prospective comparative studies” which promise to be much less burdensome on patients and providers alike than the previous coverage option which necessitates participation in randomized controlled trials to gain access to the drug. Coverage issues impacting this product have been of significant interest both to regulators and to members of Congress. The distinction between these coverage options can be found in the National Coverage Determination (NCD) published in April of 2022 which restricts access to all monoclonal antibodies (mAbs) for the treatment of AD. The AAN has been engaged with CMS and other key stakeholders with the goal of modifying these coverage restrictions in order to ensure appropriate access to new therapies in this space for more than two years. That engagement culminated in an official NCD reconsideration request submitted to CMS by the Academy on June 12 that would remove certain patients from the current coverage restrictions based on the availability of persuasive peer-reviewed evidence of the drug’s safety and efficacy for those patients.

While the AAN awaits a response to our request, we continue to engage with CMS to work within the existing coverage mechanisms to support our members and their patients who are navigating these changing circumstances. To that end, Academy staff have met with CMS to discuss a recent fact sheet released by the agency regarding a web portal being developed to facilitate the required data reporting associated with the “prospective comparative studies” required for coverage. The AAN will continue to monitor developments in this space, the AAN will continue to monitor developments in this space as additional information is released by CMS.