Companion diagnostic tests (CDTs) can offer a multitude of potential benefits such as improved effectiveness, improved side effect profiles and streamlined clinical trials, but assessing the clinical and economic value of these tests can be challenging. The technology is evolving rapidly, but a clear idea of what evidence is necessary to enable a payer to fully evaluate the diagnostic may be lagging.

The lack of consistent value-based coverage and reimbursement of diagnostic tests presents a significant barrier to patient access to personalized medicine products. As a co-author of a peer-reviewed study funded by the National Pharmaceutical Council (NPC) and published in the Journal of Managed Care & Specialty Pharmacy, I worked with Robert Dubois at NPC and our colleagues at the University of Washington to outline a framework to assist managed care organizations in determining the value of CDTs.

How do payers assess value? Based on the information gathered from a literature review and interviews with payers, we developed and tested a value assessment tool aimed at providing clarity and consistency in the evaluation of diagnostics. The tool reflects perceived value drivers and consists of four main sections:

• Eligibility for review: is the test a companion test?
• Prioritization of review: is a standalone evidence review of the test warranted?
• Clinical review: are the test results valid and clinically useful?
• Economic review: does the test provide good value?

Existing frameworks for evaluating the value of companion tests are often too cumbersome or inconsistently applied for the average managed care decision-maker to complete in a timely manner, thereby slowing down access to personalized medicines. Our value assessment tool is designed to capture all the different types of companion diagnostics, and be simple to use, thus bringing greater efficiency to the CDT evaluation process.

“As more CDTs enter the market,” we write, “it will become increasingly important for those evaluating their use to quickly gain a sense of their value… [U]sing a formal tool to guide the evaluation process by prioritizing assessments and focusing on key drivers may improve the efficiency and effectiveness of CDT value assessment.”

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Daryl Pritchard, Ph.D.
Vice President, Science Policy
Personalized Medicine Coalition