Purser M, Snyder S, Zimmerman B, Spinner D. Can we demonstrate the value of next-generation diagnostic testing approaches within traditional value frameworks? Presentation to be given at the Virtual ISPOR Europe 2020; November 2020.

Utilization of next-generation testing (NGT) that includes multiple gene/genomic biomarkers including comprehensive cancer profiling provide a wealth of information to clinicals and patients. The increase in the number of disease-related biomarkers and targeted therapies can provide more timely clinical diagnosis and efficient treatment. However, these innovative tests are often not reimbursed, and pathways for reimbursement are inconsistent, often fragmented, or nonexistent. The panel will discuss the applicability of current HTA frameworks for these tests, and why and how NGT may or may not be different from other diagnostic testing modalities. Are new methodologies and/or criteria needed? What evidence may be needed to measure and assess their value, and how can manufacturers and payers more consistently evaluate and share the risks and rewards of these innovated tests that is sustainable? This forum will introduce the new key project paper which is a collaboration between the Precision Medicine and Advanced Therapies SIG and the Medical Devices and Diagnostics SIG and being co-chaired by Daryl Spinner and Susan Snyder. Following the forum, we will have a brief PMAT SIG meeting. The meeting will focus on activities of the SIG and varies ways to be involved and engaged with the SIG. We will poll attendees to identify areas of greatest interest, and generate ideas for various methods for members to be involved and engaged with the SIG.

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