Revolutionizing Regulatory Pathways: Unleashing the Power of Real-World Evidence, Adaptive Trials, and Synergistic Collaboration for Expedited FDA Device Approval, Breakthrough Designation, and CMS Reimbursement


Discussion Leader: Renée JG Arnold, PharmD, RPh, NHLBI, National Institutes of Health, Miami Beach, FL, USA
Discussants: Douglas Kelly, MD, Center for Devices & Radiological Health (CDRH), Food and Drug Administration, Silver Spring , MD, USA; Steven Farmer, MD, PhD, Centers for Medicare & Medicaid Services, Baltimore, MD, USA; Peter Neumann, ScD, Tufts Medical Center, Boston, MA, USA


This panel will explore the use of real-world evidence (RWE), adaptive trials, and enhanced collaboration between the US Food and Drug Administration (FDA) and the US Centers for Medicare and Medicaid Services (CMS) to expedite FDA device clearance, breakthrough designation, and subsequent reimbursement decisions.


The proposed Transitional Coverage for Emerging Technologies (TCET) pathway at CMS for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. US National Institutes of Health [NIH] (Dr. Arnold), FDA (Dr. Kelly), CMS (Dr. Farmer), and academic policy (Dr. Neumann) experts will share insights on leveraging these approaches to accelerate patient access to innovative medical devices.

Dr. Arnold will discuss some of the patient cohort concerns of using RWE in fit-for-purpose trials to enable inferences about healthcare resource utilization in support of healthcare decision-making. Dr. Kelly will highlight key features of the FDA Breakthrough Devices Program. Dr. Farmer will provide a history of the CMS TCET pathway to reimbursement. Dr. Neumann will argue that CMS, in light of its growing role in advancing TCET, Coverage with Evidence Development (CED) approaches and Medicare drug price negotiations under the Inflation Reduction Act, is inescapably assuming a more active role as a health technology assessment (HTA) agency. The panel will address the opportunities and challenges in enhancing collaborations between the FDA, CMS, and HEOR professionals to expedite access to innovative devices while ensuring cost-effectiveness. Pre-program knowledge polling and post-program Q&A will be featured.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA




Health Policy & Regulatory

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