ISPOR 2022 Plenary Session: HTA on the Run

March 14, 2022

Health Technology Assessment (HTA) agencies have accelerated their process in response to the COVID-19 pandemic. In a plenary session at ISPOR 2022 on May 16th, speakers Ran D. Balicer, Noa Dagan, and Joseph Ross break down three case studies on ways different HTA bodies have approached accelerated approval processes. The first is Germany’s new Digital Health Applications (DiGa) fast track process. Next, the talk will cover the Breakthrough Devices Program (BDP) in the United States.

According to ISPOR, the third case study is, “An overview of the FDA Total Product Lifecycle Advisory Program, a menu of tools and services to get stakeholder input on evidence requirements for clinical development that is expected to provide new and enhanced pathways of regulatory and reimbursement approval in coming years. The technical and policy challenges faced during this unique time period will be highlighted, and the case studies will provide critical learnings about how to accelerate the introduction of new products and assess their impact on patients’ lives.”

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(Source: ISPOR, March 14th, 2022)

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