Economic Implications of 21-Gene Recurrence Score Assay: US Multicenter Experience

Abstract

TO THE EDITOR: Lo et al reported the first prospective treatment impact study of the 21-gene recurrence score (RS) assay (Oncotype DX, Genomic Health, Redwood City, CA) in the United States, administered to 89 women. They cited our economic analyses of the RS, where we found that the RS should be associated with similar efficacy and lower costs. As these estimates were based on projected treatment changes reported during early adoption of the RS, Lo et al suggested that “it would be interesting to recalculate cost-effectiveness based on a 20% to 30% treatment change resulting from the use of the RS assay, with most resulting in less chemotherapy use.” Wehaveperformedtheeconomicanalyses suggested,applyingtheir estimates, and also estimating effectiveness as quality-adjusted years of life gained (QALYs) associated with lower rate of chemotherapyrelated adverse events and reduced 10-year distant recurrence rate. The average QALY gained exceeded 0.2 years, and was associated with a direct medical savings of $2,099 for chemotherapy drugs, $902 for supportive care, $1,049 for management of adverse events, and $230 resulting from fewer recurrences. Including the cost of the RS, the average total direct medical savings exceeded $300 dollars per patient tested. As reported in the original economic analyses, results may vary for other centers based on their unit costs, use of medical resources (eg, type of chemotherapy used and level of supportive care), selection of patients to be tested, and how physicians and patient elect to interpret the test results. The estimates herein are likely to be conservative from a societal perspective as they exclude indirect costs associated with work productivity and the rare but meaningful consequences of chemotherapy on fertility and risk of secondary chemotherapy–related cancers. Our economic models also have been applied to the largest managed care organization in Israel. The managed care organization found the RS resulted in a 16% treatment change, associated with an average 0.17-year gain in QALYs. Unit costs are lower for cancer management in Israel, such that RS resulted in higher average cost per patient tested. The cost per QALY gained was $10,770, which was well within acceptable economic boundaries for adopting technologies in Israel. Altogether, these studies demonstrate that our early projections of the economic impact of the RS were credible.