Pcase12 Determining the Value of Diagnostic/Genetic Testing to Inform Health Plan Decision Making: Oncotype Dx as a Case Study

Economic Issues and Genomic Medicine

“…Furthermore, such analysis can help inform reimbursement decisions ( Watkins et al, 2007 ). Most importantly, they clarifi ed that without the ability to predict response to chemotherapy, these gene-expression profi les may not provide justifi able improvements (if any) in overall patient outcomes in a cost-effective manner.…”

Standardizing Quality Assessment of Observational Studies for Decision Making in Health Care

“…22 In the third case study, the reimbursement of the Oncotype Dx, a test for the identification of recurrence risk for women with early stage breast cancer, was deemed acceptable by the health insurer United Healthcare for 18 months if the test led to reduced volume of chemotherapy in those women who had been identified as low risk. 23 The final example of "Coverage with Evidence Development" has been suggested by the Centers for Medicare & Medicaid Services (CMS), whereby reimbursement is given for a limited time on the condition that evidence of effectiveness and/or safety of treatment is collected, often as part of real-world trials. 24,25 Agreements like the ones outlined above may allow additional data collection for new therapeutic interventions while limiting the risk for the payer.…”