Research by Johnson & Johnson and Avalere Health highlights that calls for the adoption of value assessment using threshold-based cost-effectiveness analysis (CEA) risk concealing unresolved issues with thresholds in other countries, as well as ongoing disagreements among economists about whether and how to establish thresholds in the first place.
Avalere Health researchers reviewed peer-reviewed literature on CEA, interviewed both experts on thresholds outside the U.S. and experienced U.S. stakeholders to assess the relevance and transferability of threshold-based CEA for U.S. decision-making.
The literature review revealed that the academic debate about thresholds is diverse, but the consensus is that they differ widely and that the ones being used are arbitrary. In the field of pharmaeconomics, various approaches to operationalizing thresholds have been debated for decades, yet little agreement exists on how their actual value should be determined.
Experts from outside the U.S. reported that these unresolved tensions and arbitrarily set thresholds lead to several challenges in practical decision-making. U.S. healthcare stakeholders expressed skepticism toward importing centralized value assessment models to the U.S. and rejected prioritizing reimbursement based on predetermined thresholds or calculations using metrics like QALYs, which were found to be discriminatory by the U.S. National Disability Council.
The study affirms the concern that threshold-based CEA conflicts with prevailing values in the U.S. and its preferences for individual choice, autonomy and personal freedom.
This research was funded by Johnson & Johnson. For full details on the study design, methods and limitations, see: Neumann U, Ciarametaro M and Banks J. “ICER thresholds in cost-utility analysis: Assessing conceptual relevance and practical adequacy for drug reimbursement decision-making in the US.” Johnson & Johnson Innovative Medicine. Poster [Link 1, Link 2] presented at: Academy of Managed Care Pharmacy (AMCP) Nexus 2025; October 27-30, 2025; National Harbor, MD.