Improving the Efficiency and Quality of the Value Assessment Process for Companion Diagnostic Tests: The Companion Test Assessment Tool

Authors: Canestaro, W; Pritchard, D; Garrison, L; Dubois, RW; Veenstra, D.
Publication: Journal of Managed Care and Specialty Pharmacy, August 2015.

A peer-reviewed study funded by the National Pharmaceutical Council and co-authored with the University of Washington School of Pharmacy examined some of the barriers to incorporating a Companion Diagnostic Test (CDT) into drug treatment decisions and outlined a framework to assist managed care organizations in determining how to evaluate CDTs.

CDTs can offer a multitude of potential benefits such as improved effectiveness, selected patient populations and improved side effect profiles, but assessing the value of these tests can be challenging. First, tests may be developed and approved in different ways: CDTs may be developed either in conjunction with a drug or after the drug has come to market and are approved by the Food and Drug Administration (FDA); there are also laboratory developed tests (LDTs) that do not undergo FDA approval. Second, the technology in this area is evolving so rapidly that the evidence or ability for a payer to fully evaluate the diagnostic may be lagging.

Regardless of the development pathway, both CDTs and LDTs can be utilized to target whether a specific treatment will work in a particular patient. Diagnostics can help to determine whether a treatment will be effective and or safe for an individual patient based on his or her individual characteristics. This is especially important for cancer and other conditions when there is little time to test different treatment approaches. And, if payers are uncertain whether to provide coverage for companion diagnostics, it could limit the accessibility of targeted cures and treatments for patients.

When it comes to identifying value, what does that mean to payers? Based on the information gathered from a literature review and interviews with payers, the study authors developed and tested a tool aimed at providing some clarity and consistency in the evaluation of diagnostics. The tool reflected perceived value drivers and consisted of four main sections:

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

Although there are existing frameworks for evaluating the value of companion tests, they are often too cumbersome for the average managed care decision maker to complete in a limited amount of time. And while this tool has limitations by not taking budget impact or clinical outcomes into account, the “tool is designed to be both simple to use and capture the majority of variability in the testing, thus offering greater efficiency in the CDT evaluation process.”

The study authors note, “As more CDTs enter the market, 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.”