Payers and the assessment of clinical utility for companion diagnostics.

The decision makers who approve or deny payment for health-care services review many new technologies. Reimbursement for companion diagnostics for expensive drugs ("personalized medicine") is already under close policy scrutiny, in line with long-standing concerns about overuse of diagnostic tests. Evaluation of diagnostic tests adds some complexities to the payer's comparative-effectiveness evaluation for drugs alone. Currently, decision-making frameworks suitable for companion diagnostics are being developed for practical application by payer policy makers.