Budget Impact of the Oncotype DX Test in Early-Stage Breast Cancer for the Brazilian Private Health Care System.

Purpose: Adjuvant chemotherapy decisions for early-stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer remain challenging, requiring a balance between treatment efficacy and avoiding overtreatment. Gene expression signatures, such as the Oncotype DX assay, are valuable tools to predict recurrence risk and guide chemotherapy use. This study estimates the budget impact of incorporating the Oncotype DX test into clinical practice for patients with HR+/HER2- early-stage breast cancer in Brazil's private health care system.

Methods: A budget impact analysis was performed using a hybrid decision tree-Markov model with transitions between recurrence-free survival, distant recurrence, acute myeloid leukemia, and death. The eligible population was derived from epidemiologic data. Subgroup analyses included node-negative (N0) patients stratified by age and clinical risk and node-positive (N1) patients stratified by menopausal status. The model assessed direct medical costs over 5 years without applying a discount rate. Two scenarios were analyzed: scenario 1, with progressive market uptake (40%-80% over 5 years), and scenario 2, with universal testing.

Results: The introduction of the Oncotype DX test was associated with 5-year cost savings of approximately $19.3 million US dollars (USD; scenario 1) to $26.7 million USD (scenario 2). Incremental costs were observed only in N0 low-risk patients 50 years and younger ($9.5-$16.9 million USD) and premenopausal N1 patients ($2.2-$4.4 million USD).

Conclusion: Incorporating the Oncotype DX test is expected to optimize chemotherapy recommendations, reduce overtreatment, and generate cost savings in most subgroups. In Brazil's private health care system, the reduction in chemotherapy-related costs is anticipated to fully or partially offset the cost of testing.