Sean Tunis

Oct 25, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

Medicare has recently endorsed the concept of “fit-for-purpose” (FFP) studies to support ongoing evidence generation as a condition of coverage for selected emerging medical products.

Oct 24, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

When Medicare coverage for a drug, device, or other medical technology is conditioned on additional evidence development, several important policy questions arise: What will be the utility of the evidence generated for informing coverage decisions and, ultimately, the care of Medicare beneficiaries? What will be the burden of conducting the study? And how will the evidence development affect access to the technology by patients?

Jun 23, 2023 | healthaffairs.org | Sean Tunis |Peter J. Neumann

On July 6, 2023, the Food and Drug Administration (FDA) is expected to decide whether to grant traditional approval for Leqembi (lecanemab), a monoclonal antibody (mAb) for patients with mild cognitive impairment or mild Alzheimer’s disease. Lecanemab received accelerated approval in January 2023.