Economic evaluation of the 21-gene recurrence score test in early-stage hormone-receptor positive breast cancer

Patients with early-stage non-metastatic breast cancer undergo curative-intent breast surgery followed by endocrine treatment and/or chemotherapy to reduce cancer recurrence risk. The choice of these therapies often depends on clinical-pathological assessments of the potential benefits from chemotherapy. Patients with early-stage hormone-receptor positive breast cancer benefit largely from endocrine therapy alone, but guidelines often also recommend chemotherapy despite perhaps small and/or uncertain benefits. The 21-gene recurrence score (Oncotype DX®: RS) is a laboratory test performed on breast cancer tissue which appears to reduce the overall chemotherapy utilization by identifying hormone-receptor positive breast cancers that don’t benefit from chemotherapy. RS however is associated with high costs (~ $4,000 Cdn per patient), and is not currently funded in Canada. This economic evaluation will examine the upfront incremental costs of RS testing in the context of all relevant downstream health gains and cost savings. A decision analysis framework involving hypothetical patients cohorts will be employed to determine if RS-test based chemotherapy strategy is associated with good “value for money” compared with current practice in Canada, and its potential budget impact in Nova Scotia. If RS-testing proves to be an economically-favourable strategy, regulatory agencies will be approached to fund RS testing for women with early-stage hormone-receptor positive breast cancer. 1) To examine the CU associated with "RS test" vs. "NO RS" - guided chemotherapy strategies for early-stage, node -negative and -positive, hormone receptor positive breast cancer in Canada.The incremental costs and quality-adjusted life-years associated with RS testing (i.e. RS test vs. NO RS) - guided chemotherapy will be examined to determine if RS testing is asscoiated with good "value for money" in patients wth early-stage hormone-receptor positive breast cancer.2) To compute the potential budget impact associated with RS testing for early-stage, node -negative and -positive, hormone receptor positive breast cancer in Nova Scotia.The potential annual budget impact associated with RS test use in Nova Scotia, for patients with node-negative and node-positive hormone-receptor positive breast cancer who are being considered for adjuvant chemotherapy, will be examined.