A recently published value assessment tool can help provide information about the overall value of companion diagnostic tests (CDTs) associated with targeted drug therapies. CDTs are essential for the effective use of such therapies, but payers and providers are only just beginning to develop reimbursement and treatment guidelines for their use. A complex array of factors influence the clinical and economic outcomes of CDTs, making it difficult to assess their overall value. Stakeholders are seeking information such as whether a CDT improves patient outcomes and whether it is worth the cost.
In order to identify the main factors that determine the value of CDTs, a team of researchers led by David L. Veenstra (Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy, University of Washington, Seattle) conducted a systematic review of literature on cost-effectiveness of CDTs. The value drivers identified were clinical validity of testing; efficacy, safety, and cost of baseline and alternative treatments; cost and mortality of health states; and biomarker prevalence and testing cost. Veentra’s team also conducted informational interviews with a diverse group of stakeholders, who identified regulatory status, actionability, utility, and market penetration as additional value drivers for CDTs.
Next, the team developed a practical evidence review tool, in the form of an ordered series of questions, that captured these value drivers and could easily be used by experts and non-experts alike. A draft of the tool was pilot-tested, after which a few changes were made to the tool to make it easier to use and more relevant to the needs of its users—primarily individuals within managed care organizations reviewing emerging CDTs. Questions included in the tool pertain to eligibility for review, prioritization of review, clinical review outcomes, and economic review outcomes. The authors published their preliminary results in the Journal of Managed Care & Specialty Pharmacy.
The authors caution that, because of the anticipated limitations of the users’ understanding of genomics, resource constraints, and an aim of increasing efficiency, some potentially relevant factors may be excluded, preventing the tool from providing an exhaustive review of each test. Still, the value assessment tool presents the first framework to allow healthcare decision makers for evaluating evidence regarding clinical and economic value of CDTs.—Kara Rosania
