Cost-Utility Analysis of Multigene Assays to Guide Treatment Decisions for Node-Negative Early Breast Cancer

Area of Science:

• Oncology
• Genomics
• Health Economics

Background:

• Limited prognostic information from traditional factors in HR+/HER2- early breast cancer.
• Potential for overtreatment or undertreatment due to inadequate risk stratification.
• Need for improved methods to guide treatment decisions in early-stage breast cancer.

Purpose of the Study:

• To evaluate the cost-effectiveness of four multigene expression assays.
• Compare the 21-gene, 70-gene, 12-gene, and 50-gene assays against clinicopathologic risk assessment alone.
• Determine the economic value of genomic testing in HR+/HER2- early breast cancer management.

Main Methods:

• Decision tree and Markov modeling for lifetime cost-effectiveness analysis.
• Incorporation of clinical expert insights and literature data for chemotherapy allocation.
• Utilized data from TAILORx, MINDACT, and TransATAC studies for recurrence probabilities.

Main Results:

• The 21-gene and 50-gene assays were less costly and more effective than standard assessment.
• The 70-gene and 12-gene assays demonstrated cost-effectiveness with specific ICERs.
• All four multigene assays showed favorable economic value from a US societal perspective.

Conclusions:

• All four multigene assays are cost-effective for HR+/HER2- early breast cancer.
• Genomic assays refine treatment decisions and improve patient outcomes.
• The 21-gene assay offers the highest cost savings and QALY gains, predicting chemotherapy benefit.