Has the economic validity of the Oncotype DX® assay been investigated?

Economic validity refers to the completeness, quality and reliability of the analyses used to assess the economic implications of novel technologies. A summary of the existing health economic studies is contained here as well as data derived from our proprietary economic Budget Impact Model named FIRST (Frequency in Recurrence Score® Treatment). The FIRST model budget is available for presentation at your organization by your Managed Care Account Executive upon request.

In a 2005 economic analysis of the Recurrence Score result in LN-,ER+ patients receiving tamoxifen, Hornberger et al. performed a cost-utility analysis using a decision analytic model.13 Using a Markov model, they forecasted overall survival, costs and cost effectiveness of using the Recurrence Score in patients classified as having low or high risk of distant recurrence based on 2004 National Comprehensive Cancer Network (NCCN) clinical guidelines. Given the reclassification rates noted above, among a hypothetical cohort of 100 patients, Recurrence Score result was predicted on average to increase quality-adjusted survival by 16.3 years and reduce overall costs by $155,128.

Instead of using this hypothetical reclassification model, economic benefits can now be assessed from the published clinical utility of the test described on the Clinical Utility sub-page (change in treatment decisions from Table 1) and actual health plan costs for adjuvant chemotherapy using the Genomic Health Budget Impact FIRST model. For example, in a 2 million member plan, approximately 773 women are eligible for the test. If half receive the test, given the high and increasing cost of adjuvant chemotherapy, supportive care and management of adverse events, the use of the Oncotype DX assay is estimated to save approximately $1,930 per woman tested (given an aggregate 34% reduction in chemotherapy use).

A demonstration of the budget impact model is available to managed care plans and CMS upon request to the account manager. Contact us through the customer service number on the Contact Us sub-page.