Improving Coordination Between the FDA and CMS: Exploring Potential Policy Solutions to Improve Patient Access to Drugs Granted Accelerated Approval

ISSUE: Recent events, including controversies around the approval of aducanumab (Aduhelm), the monoclonal antibody for early Alzheimer’s disease, highlight the problems that can arise because the FDA and CMS lack mechanisms to coordinate their decision making, particularly around promising technologies for serious illness. For drugs approved through expedited pathways, there is a growing evidence gap between FDA and CMS decisions, highlighting the limited policy tools that are currently available to either FDA or CMS to responsibly navigate that space. We will discuss ways in which the FDA and CMS might better coordinate their policy mechanism for promising technologies in order to produce more transparent, predictable, evidence- and outcomes-based processes for new medicines. We will debate the merits of different policy strategies, including discussion of intended and unintended consequences and barriers to implementation.

OVERVIEW: The moderator will give a 10 minute presentation on background information for this issue, including a brief description of the aducanumab case study. The panel will offer their perspectives on different policy solutions that could be used to achieve coordination, including the potential benefits and harms of each. Tunis, formerly chief medical officer at CMS will address options including: improved communication between the Agencies; early advice to product developers from CMS; use of real world evidence; reform of coverage with evidence development; innovative payment mechanisms; and others. Kaltenboeck, who formerly worked on the Senate Finance Committee, will discuss potential legislative solutions. Health policy makers and researchers will be the best audience for this panel because it will apply directly to their work, but the panel will also be of interest to individuals working in or with the drug industry since they navigate both the drug approval and reimbursement processes.