ARE WE READY FOR A CURE? KEY VALUE DEMONSTRATION AND POLICY CONSIDERATIONS FOR THE NEW WAVE OF POTENTIALLY CURATIVE THERAPIES

Author(s)

Gregory W. Daniel, PhD, MPH, RPh, Duke University, Washington, USA; Eric Faulkner, MPH, and Assistant Professor, Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, Chapel Hill, USA; Tamara Syrek Jensen, MD, Center for Medicare and Medicaid Services, Baltimore, USA; Simu K. Thomas, PhD, Novartis Pharmaceuticals Corporation, East Hanover, USA

ISSUE: A new wave of approximately 700 cell, gene, and immunotherapies are working their way to market, with the initial vanguard of entrants already emerging in the marketplace. These regenerative therapies leverage truly novel approaches and offer the potential to suspend disease progression or even cure some diseases. Some of these therapies may only have to be administered a single time, raising new reimbursement and access policy issues that the global marketplace has not yet addressed. The definition of what constitutes a cure and the associated value demonstration requirements that offer proof must also be considered, as well as new patient management and payment models. While these potentially curative therapies offer tremendous promise, are we prepared to absorb them? OVERVIEW: This panel will debate the implications of potentially curative therapies and consider value demonstration and policy requirements necessary to support patient access. Eric Faulkner will open the panel with an overview of the key methodological, reimbursement and policy issues surrounding potentially curative therapies, citing early examples from the global marketplace. Simu Thomas will offer a global manufacturer perspective and explore key practical business considerations associated with advancing curative therapies, including market-specific issues that increase the complexity of developing novel treatments.  Tamara Syrek-Jensen will provide a US national payer perspective and discuss key factors that a payer would consider in assessing the value of potentially curative therapies.  Greg Daniel will represent a policymaker perspective and discuss necessary key reimbursement and payment policy changes to accommodate curative therapies leveraging US health system examples.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Code

IP2

Topic

Health Policy & Regulatory, Specialized Treatment Areas

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