Molecular Testing for Thyroid Nodules Recommended as Adjunct to Fine Needle Aspiration

Dr. Theoharis said that although the Veracyte assay is not in use at Yale, it is noteworthy. “As far as I understand from [the developer’s] presentations, they’ve taken an alternative approach: Rather than attempting to prove malignancy, they try to prove that a given nodule is benign. That is quite innovative, but I am unclear if it is cost effective,” he said.

mRNA Test Also Proves Cost Effective

Dr. Ladenson said that such cost effectiveness data do, in fact exist: He and his colleagues at Johns Hopkins recently published a study (J Clin Endocrinol Metab. 2011;96(11):E1719-E1726) on the mRNA test’s cost effectiveness and concluded that it reduces the overall financial impact of managing patients with thyroid nodules. The researchers based their analysis on a hypothetical group of adult patients with cytologically indeterminate thyroid nodules. A wide variety of factors that could influence cost were included in the analysis, including those related to inpatient care, primarily surgery, and outpatient care, such as clinic visits and sonography. All calculations were based on 2010 Medicare payment rates, including reimbursement for the test itself, which is set at $3,200. Quality of life (QOL) estimates and the probabilities of pursuing various management options were also included in the analysis.

Their model showed that when current practice patterns were followed—that is, no mRNA testing—57 percent of patients with indeterminate cytology underwent surgery for what ultimately proved to be a benign nodule. When the mRNA test was routinely applied to such patients, only 14 percent had surgery. On a per-patient basis, the cost of care for patients who did not undergo mRNA tests in the model was $12,172, versus $10,719 for those in whom management was guided by the mRNA test.

Those seemingly modest savings are a function of performing “a judiciously designed cost-modeling study,” Dr. Ladenson said. “For example, using Medicare payment rates in our base case, about $3,000 per surgery, biases the analysis against this novel test.” In many real-world clinical situations, he explained, where up to 30 percent of patients are on fee-for-service private insurance plans, “the costs of thyroid surgery can be $10,000 dollars or more.” In such cases, he noted, “You can see how the cost savings from avoided surgeries can really add up.”

Even using the lower-scale payment rates allowed by Medicare, he noted, nationwide savings are impressive. “Our analysis predicted that [due to the mRNA test] 74 percent fewer surgeries would be performed in patients with benign thyroid nodules,” he said. “If the mRNA test was performed in all of the 450,000 patients annually who have indeterminate cytology results, that translates to a savings of $122 million in the U.S.”

Personalized Medicine Gets a Boost

Asked to review the cost-effectiveness data from Dr. Ladenson’s hypothetical patient group, Dr. Theoharis said the findings “are just that, hypothetical. I’d like to see those savings documented in a real-world clinical trial.”