Performance Goals for an Adjunct Diagnostic Test to Reduce Unnecessary Biopsies After Screening Mammography: Analysis of Costs, Benefits, and Consequences.

PURPOSE: Because benign biopsies resulting from false-positive mammographic findings are a known harm of breast cancer screening, physicians and test manufacturers are searching for ways to reduce their frequency. The aim of this study was to estimate potential costs and consequences associated with using an adjunct diagnostic test for triaging women with suspicious mammographic findings before biopsy.

METHODS: A decision model was developed to compare the use of an adjunct test before biopsy to the current standard of care for suspicious mammographic findings. The decision analysis was performed from the perspective of a national health payer, with a 1-year time horizon among women representative of the US screening population aged 40 to 79 years. Three primary outcomes were assessed: (1) incremental costs, (2) number of benign biopsies avoided, and (3) number of missed opportunities for diagnosing cancer per million women screened. Input parameters were obtained from the medical literature and expert opinion. Sensitivity analyses were performed to evaluate the effects of uncertainty in parameter estimates.

RESULTS: The base-case analysis demonstrated that the use of an adjunct diagnostic test with 95% sensitivity, 75% specificity, and a cost of $1,000 would eliminate 8,127 unnecessary breast biopsies per million women screened. However, this would cost the US health care system an additional $6,462,977 and result in 255 missed opportunities for diagnosing cancer per million women screened.

CONCLUSIONS: The addition of an adjunct test for triaging women for breast biopsy after abnormal findings on screening mammography would likely eliminate many unnecessary biopsies but also increase overall health care costs. This exploratory analysis highlights the fact that mammography remains a relatively inexpensive and effective breast cancer screening and diagnostic modality.