by Cait Kearney
Penn Memory Center (PMC) Co-Director Jason Karlawish, MD, and Medicare expert and Penn faculty member Allison Hoffman, JD, led a community discussion regarding the Centers for Medicare and Medicaid Services (CMS) proposal for the coverage of Aduhelm (aducanumab).
Aduhelm was granted approval by the Food and Drug Administration (FDA) via its accelerated approval pathway in June 2021 — a decision that sparked notable debate and controversy. Following the approval, CMS became responsible for determining how the drug would be covered by Medicare, if at all.
CMS released a preliminary coverage decision on January 11, 2022, that stated Aduhelm, and drugs like it, would be covered through “coverage with evidence” (CED).
“[CED] means Medicare will pay for a drug under a CMS approved clinical study,” said Dr. Hoffman.
Many are concerned that limiting access to Aduhelm to only those who can participate in clinical trials will perpetuate barriers to care for certain groups, such as those who live far away from testing centers.
According to Dr. Karlawish, PMC plans to be a testing site for the CMS approved study of Aduhelm, and PMC will put forward its best effort to provide equitable access to participation and to promote diversity in the trial.
“The Penn Memory Center is keenly interested in this clinical trial,” said Dr. Karlawish. “We will work with our community partners to raise awareness of this study.”
CMS is accepting public comment on the proposal until February 10, 2022. You can submit your comment on the CMS website. The decision is expected to be finalized by April 11, 2022.
Skip to certain topics covered during the community discussion by tapping on the links below.
- Background of the FDA’s decision to approve Aduhelm (4:51)
- How Aduhelm has unfolded into clinical practice (13:00)
- What is CMS? (21:20)
- What does it mean to be covered by Medicare? (22:39)
- What is “Coverage with Evidence Development” and its implications? (27:55)
- Review of the CMS proposal (32:18)
- Reactions to the proposal (41:10)
- Proposal and limits to access, inequities (43:00), PMC’s efforts for equitable access and trial diversity (49:02)
- Next steps, public comment (45:00)