Beyond the QALY: Alternatives in the US and Implications for EU

Moderator

Beth Devine, MBA, MSc, PharmD, PhD, University of Washington, Seattle, WA, United States

Speakers

Anirban Basu, PhD, University of Washington, Seattle, WA, United States; Varun Ektare, MPH, Indence Research Private Limited, Thane West, India

Purpose: Due to restrictions on QALYs in U.S. federal health decisions, alternative cost-effectiveness metrics have emerged, including EVLYG, HYT, and GRACE. These tools differ in how they value life extension, quality-of-life improvement, or both—especially for patients with poor baseline health. This session helps researchers, payers, and industry stakeholders understand the underlying assumptions of these non-QALY approaches, assess where they may be better or worse suited for evaluating the value of a given healthcare intervention, and understand the implications for HTA bodies. Description: Dr. Devine (5 mins) will introduce speakers, briefly describe the non-QALY evolution in the US, and moderate the Q&A. Dr. Basu (15 mins) will present an overview of these topics, laying out different assumptions for each metric and show new evidence on links between EQ-5D weights and GRACE methodology. Mr. Ektare (15 mins) will demonstrate the implementation of these alternative metrics in three anonymized product profiles (late-stage haem-onc therapy, chronic pain palliative, pediatric SMA gene therapy). Dr. Banks (15 mins) illustrates the challenges of using non-QALY measures in the EU context and the implications for EU HTA if the US continues to rely on these measures and also pursues most-favored-nation prices. We will engage the audience with real-time polling at the beginning and end of the panel, and 10 minutes of Q&A to discuss the strengths and limitations of each of the metrics.

Code

125

Topic

Methodological & Statistical Research, Patient-Centered Research, Study Approaches

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