Challenges in the Implementation of Generalized Cost-Effectiveness Analysis (GCEA): Debating a Path Forward

ISSUE: Incorporating broader societal value elements into health technology assessment (HTA) remains a challenge. While a recently published Generalized Cost-Effectiveness Analysis (GCEA) user guide outlines methods to empirically quantify these values, questions linger about their feasibility, fairness, and impact on pricing and coverage decisions considering the ongoing uncertainties related to double counting, threshold modifications, and surplus appropriation. This panel will debate whether and how societal value elements should shape value assessment and payer decision making in the US. OVERVIEW: Dr. Li will introduce the panel, summarize conventional approaches, and provide an overview of the current evidence and evidence gaps for GCEA. Dr. Whittington will argue for the inclusion of GCEA into value assessment and payer decision making and will provide recommendations for implementing GCEA even considering double counting, lack of a threshold, and uncertainties about manufacturer surplus. Dr. Shafrin will that additional research is needed to translate GCEA value estimates into pricing and coverage decisions. In particular, he will emphasize the intersection between fairness and efficacy as it relates to value elements. Finally, Dr. Lakdawalla will argue for the incorporation of disease severity into value assessment using a GRACE-based approach rather than ad hoc adjustments. Additionally, he will discuss whether GRACE can be integrated with other value elements (e.g., equity, option value). The panel will conclude with a debate on the overall merits of using GCEA for drug pricing and coverage. Panelists will weigh the trade-offs between the complexity of implementation and the accuracy of societal value measurement. Key questions include: Is the additional precision worth the effort? How do we prevent double counting? Do willingness-to-pay thresholds need adjustment? How does the answer to these questions vary across single payer compared to more market-based geographies?