Alzheimer’s Drug Approved; USC Policy Experts Available to Discuss FDA Approval of Leqembi

For the first time in two decades, an Alzheimer’s drug has received full Food and Drug Administration (FDA) approval. Lecanemab (Leqembi) will be available to more than a million Medicare patients in the early stages of Alzheimer’s. 

Experts from the USC Schaeffer Center for Health Policy & Economics and the USC Sol Price School of Public Policy are available to discuss the approval and related topics.

“Leqembi’s approval is an important milestone in forestalling progression of Alzheimer’s,” said Dana Goldman, dean of the USC Price School and co-director of the USC Schaeffer Center. “For the sake of patients, Medicare needs to ensure coverage but also continued development of real-world evidence on its effectiveness.”

Goldman’s expertise includes health economics and finance, health policy, the role of prevention in healthcare, healthcare reform and pharmaceutical regulation and innovation.

“This is an important approval for patients, physicians, and the health care system,” said Genevieve Kanter, associate professor at the USC Price School and senior fellow at the USC Schaeffer Center. “It will be crucial to follow patient experience with this new drug as well as how Medicare will manage the big price tag.”

Kanter is an economist whose research focuses on the FDA and regulatory issues related to biomedical technologies. Her latest commentary published in JAMA Health Forum today is “The Real Question the FDA Is Asking Its Advisory Committees.”

“When [FDA approval of Leqembi] happens, physicians and their patients will have to navigate the path to access and reimbursement, and wrestle with concerns over side effects and cost,” said Julie Zissimopoulos, co-director of the aging and cognition program at the USC Schaeffer Center and professor at the USC Price School. 

“But before those questions can be addressed, a baseline challenge awaits: who are the people who can benefit most from treatment, and how can they be identified?” she continued. “Similarly, who are the people most at risk of developing any form of dementia?”

Zissimopoulos’ comments are excerpted from her recent opinion piece in MedPage Today. Her current research focuses on the economic costs of dementia, impacts of dementia on care partners, the use of and response to drug therapies for non-dementia conditions that influence risk of dementia, and racial and ethnic disparities in diagnosis and health care treatment for dementia.