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Key considerations when assessing clinical utility for biomarker testing: A checklist
Tianyi Wang1, Kimberly Tsai2, Steven S Kheloussi3
1Omnicom Health Market Access, New York, NY.
Journal of Managed Care & Specialty Pharmacy
|August 8, 2026
Summary
Payers and laboratory benefit managers can now align on evaluating biomarker test clinical utility. A new checklist ensures consistent assessment for improved coverage decisions and patient care.
Area of Science:
- Biomarker testing
- Health economics
- Oncology
Background:
- Establishing clinical utility of biomarker tests is crucial for benefit design.
- Discrepancies exist between payers and lab benefit managers in evaluating clinical utility and meaningful outcomes.
- This can complicate coverage policies for providers and manufacturers.
Purpose of the Study:
- To develop a checklist for aligning payers and laboratory benefit managers on evaluating biomarker test clinical utility.
- To promote a shared, actionable approach to assessing clinical utility and evidence requirements.
- To enhance transparency and structure in coverage decision-making for biomarker tests.
Main Methods:
- Expert insights were gathered from an AMCP partnership forum on precision medicine in oncology.
- A checklist was developed based on these insights to guide the evaluation process.
- The checklist emphasizes a structured approach, starting with analytical and clinical validity.
Main Results:
- The checklist guides the categorization of tests by intended use and actionability.
- It outlines the assessment of clinical utility, focusing on evidence relevance, strength, and consistency.
- Economic and operational factors are considered after clinical utility is established.
Conclusions:
- The developed checklist provides a framework for consistent evaluation of biomarker test clinical utility.
- It aims to bridge differences between payers and laboratory benefit managers.
- This structured approach supports informed coverage decisions and advances precision medicine in oncology.
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