Benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts.

BACKGROUND: Many states have laws requiring mammography facilities to tell women with dense breasts and negative results on screening mammography to discuss supplemental screening tests with their providers. The most readily available supplemental screening method is ultrasonography, but little is known about its effectiveness.
OBJECTIVE: To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts.
DESIGN: Comparative modeling with 3 validated simulation models. DATA SOURCES: Surveillance, Epidemiology, and End Results Program; Breast Cancer Surveillance Consortium; and medical literature. TARGET POPULATION: Contemporary cohort of women eligible for routine screening. TIME HORIZON: Lifetime. PERSPECTIVE: Payer. INTERVENTION: Supplemental ultrasonography screening for women with dense breasts after a negative screening mammography result. OUTCOME MEASURES: Breast cancer deaths averted, quality-adjusted life-years (QALYs) gained, biopsies recommended after a false-positive ultrasonography result, and costs. RESULTS OF BASE-CASE ANALYSIS: Supplemental ultrasonography screening after a negative mammography result for women aged 50 to 74 years with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models, 0.14 to 0.75), gained 1.7 QALYs (range, 0.9 to 4.7), and resulted in 354 biopsy recommendations after a false-positive ultrasonography result (range, 345 to 421) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325,000 per QALY gained (range, $112,000 to $766,000). Supplemental ultrasonography screening for only women with extremely dense breasts cost $246,000 per QALY gained (range, $74,000 to $535,000). RESULTS OF SENSITIVITY ANALYSIS: The conclusions were not sensitive to ultrasonography performance characteristics, screening frequency, or starting age. LIMITATION: Provider costs for coordinating supplemental ultrasonography were not considered.
CONCLUSION: Supplemental ultrasonography screening for women with dense breasts would substantially increase costs while producing relatively small benefits. PRIMARY FUNDING SOURCE: National Cancer Institute.