ISSUE: Drug costs have been a concern among policymakers due in part to the recent introduction of innovative new treatments, including gene therapies. Understanding the effectiveness of drugs is key to value based purchasing, but the lack of agreement on the most critical outcomes and the data infrastructure to measure these outcomes hampers progress. Chuck Shih will address how industry chooses which outcomes to measure in clinical studies. Elizabeth Seeley will discuss the payer perspective on outcome-based contracting and the limited availability of meaningful metrics to measure effectiveness. Sean Tunis will review his work with international efforts such as COMET (Core Outcome Measures for Effectiveness Trials) and ICHOM (International Consortium of Health Outcome Measurement) to drive consensus among stakeholders on adoption of core outcome sets across the healthcare system. The panelists together with the participants will debate how core outcome sets could be implemented, including issues of funding and governance. OVERVIEW: Systematic reviews and technology assessments often find that clinical trials use a range of different outcomes measures, making it difficult to compare the effectiveness and value of different treatments. With this uncertainty, payers have started to look at outcomes based contracting for high cost drugs, where payment is tied to real world outcomes of treatment. However, the lack of consensus on outcomes measures sometimes leads to unclear impact of these models in the real world setting as well. Consensus on core outcome sets that could be used for research studies and for implementation of a real world data infrastructure would address these problems but there are questions about funding and aligning incentives for adoption. Organized by the ISPOR Health Technology Assessment – Pharmacy and Therapeutics (HTA-P&T) Roundtable – North America