Key considerations when assessing clinical utility for biomarker testing: A checklist.

Abstract

Establishing the clinical utility of biomarker tests is a critical component of benefit design. However, payers and laboratory benefit manager organizations may differ in how they evaluate clinical utility for a given test, including how they determine whether evaluated outcomes are clinically meaningful. These differences can create challenges for providers and manufacturers when navigating coverage policies across organizations. Based on expert insights from a partnership forum hosted by AMCP on June 24-25, 2025, in Alexandria, VA, on the topic of precision medicine in oncology, we developed a checklist of considerations to align payers and laboratory benefit managers around a shared, actionable approach to evaluating the clinical utility of biomarker tests and the types of evidence used to demonstrate it. The checklist begins with confirmation that analytical and clinical validity have been established before assessing clinical utility. Tests should then be categorized based on their intended use and whether they provide actionable information that informs clinical decision-making and improves patient health outcomes. Assessment of clinical utility includes consideration of the relevance, strength, and consistency of the supporting evidence base. After clinical utility is established, economic and operational considerations may also be evaluated. This checklist is intended to support a more transparent and structured approach to evaluating clinical utility in coverage decision-making.