The budget impact of utilizing the Oncotype DX Breast Recurrence Score® test from a US healthcare payer perspective.

Background and objectives The Oncotype DX Breast Recurrence Score® test is used to estimate distant recurrence risk of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer and inform decisions on the use of adjuvant chemotherapy. A model-based budget impact analysis compared the Oncotype DX test in combination with clinical-pathological risk against using clinical-pathological risk alone for HR+/HER2- node-negative (N0) and node-positive (N1; 1-3 axillary lymph nodes) early-stage breast cancer patients. Materials and methods Test and medical costs associated with treatment of breast cancer were assessed through a US healthcare payer perspective. Distributions of patients by Recurrence Score result and distant recurrence probabilities with chemo-endocrine and endocrine therapy were derived from the TAILORx (N0) and RxPONDER (N1) trials. Changes in budget impact were evaluated over a five-year horizon for a 1,000,000-member hypothetical health plan. Results With the Oncotype DX test, there was an incremental budget impact of $261,067, (per member per month (PMPM): $0.004), in the N0 population, and $56,143, (PMPM: $0.001) in the N1 population over the five-year period. The largest budget impact reduction in the N0 population was attributed to reduced breast cancer recurrence costs (incremental: -$633,457, PMPM: -$0.011), whilst chemotherapy sparing reduced costs in the N1 population (incremental: -$94,884, PMPM: -$0.002). Conclusion The clinical benefit of using the Oncotype DX test to inform adjuvant chemotherapy decisions has been shown in multiple randomized controlled trials. This analysis demonstrated that while using the Oncotype DX test to inform adjuvant chemotherapy decisions may slightly increase US healthcare costs over an initial five-year time horizon (driven by a cost increase in the first year with cost savings reflected in remaining 4 years), there is significant scope for cost savings when assessing beyond this period due to avoided downstream costs of distant recurrence and long-term chemotherapy adverse events. PMPM costs also remain low across all populations examined, demonstrating a close to neutral budget impact.