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Capitol Hill Report: FDA Approves Lecanemab for Alzheimer’s
continued from cover 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, as additional information is released by CMS.
Latest Advocacy News
On June 22, the Centers for Medicare & Medicaid Services (CMS) announced a proposed new pathway for coverage of innovative new medical devices known as the Transitional Coverage for Emerging Technologies (TCET) pathway. TCET is voluntary and aims to reduce uncertainty about coverage options through the use of coverage with evidence development processes to expedite Medicare coverage of certain Breakthrough Devices. The AAN is currently reviewing this proposal and plans to submit formal comments.
On June 30, CMS released a revised guidance for the Medicare Drug Price Negotiation Program that was established by the Inflation Reduction Act and is set to begin forcing negotiation on the most costly drugs beginning in 2026. This revised guidance seeks to prevent potential exploitation of certain provisions of the program aimed at protecting small biotech firms and manufacturers of drugs designated for treating rare, or orphan, diseases. The AAN continues to monitor the development of this program and will provide comments as appropriate.
