A new analysis of the Humana database shows that the 21-gene recurrence score (RS) molecular assay (OncotypeDX; Genomic Health) leads to targeted management of early-stage breast cancer and reduces payer’s costs (Hornberger J, et al. J Oncol Pract. 2011;7[3s]:e38s-e45s). “We found that the tests save money, and women have improved health, because they do not get chemotherapy that they don’t need,” John Hornberger, MD, MS, President and Chief Executive Officer of Cedar Associates, Menlo Park, CA, and Adjunct Clinical Professor, Stanford University, told Value- Based Cancer Care. Adjuvant chemotherapy in earlystage breast cancer is guided by an assessment of the individual patient’s risk for recurrence. The American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend the 21-gene RS as a clinically valid tool for improving risk assessment for chemotherapy. A meta-analysis of decision-impact studies showed that the RS reduces the overall utilization of chemotherapy by 27% (Lo SS, et al. J Clin Oncol. 2010;28:1671-1676). Previous health economic studies were based on the hypothesized use of adjuvant chemotherapy, showing the A21-gene RS improved breast cancer outcomes and saved costs. This is the first study to rely on real-life data reflecting actual practice, said Dr Hornberger; this will help resolve the questions of the assay’s validity in actual practice. “Policymakers are keenly interested in learning how the assay affects outcomes and costs…after some period of experience with the assay,” said Dr Hornberger. “We incorporated the utility reported in the meta-analysis with real-world costs associated with adjuvant chemotherapy treatment as obtained from Humana to evaluate the cost-effectiveness of the 21-gene RS.” Payer’s Coverage Decision Validated Coinvestigator Louis Hochheiser, MD, Medical Director at Humana, was interested in validating Humana’s decision in 2006 to cover the assay. Genomic Health (which funded the study but had no involvement in the analysis) was interested in showing its cost-effectiveness and in confirming the clinical benefits in real-life practice. Genomic Health “gets pushback all the time, which is true for any manufacturer of a drug or device today,” Dr Hornberger said in the interview. “They are all being asked, ‘Why should we pay for this?” He emphasized the importance of validating the clinical utility of all molecular assays (which were introduced in 2005), as well as this test. The current study looked exclusively at the utilization of the test in 925 women who were lymph node–negative, estrogen receptor–positive; this study validated cost benefits for this patient population. There is a growing body of studies exploring whether the RS test should be used in other populations, Dr Hornberger added. “The analysis showed that the use of the RS does make a difference in how physicians treat patients. A lot of decisions were changed as a result of the test.” Interventions Reduced, Costs Saved, Outcomes Improved Of the 925 women, 255 (27%) received adjuvant chemotherapy; 10% of women classified as low risk by the assay received adjuvant chemotherapy compared with 36% of those at intermediate risk and 72% of those at high risk. Humana spent $3,784,200 for the 952 assays, with projected net savings of $1,104,320, or an average of $1160 per test, as a result of the test’s impact on treatment decisions. The immediate per-patient savings were $1885 for a reduction in chemotherapy, $2568 for less supportive care, and –$472 for side-effect management. In addition, the assay saved $199 per woman by preventing distant recurrence. A separate analysis accounted for a 3% risk of chemotherapy-induced second primary tumors, which increased the net savings to $1,503,423. The estimated net savings for Humana with the RS was >$1 million during the test period. (Costs saved from reduced laboratory work-up and treatment-related outpatient visits were not included in the analysis.) All risk categories gained qualityadjusted life-years. Cost-effectiveness acceptability curves showed an 81% probability that the 21-gene RS would be cost-saving to a health plan.
