Background
At least nineteen states have laws that require telling women with dense breasts and a negative screening mammogram to consider supplemental screening. The most readily available supplemental screening modality is ultrasound, yet little is known about its effectiveness.
Objective
To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasound 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; the medical literature.
Target Population
A contemporary cohort of women eligible for routine screening.
Time Horizon
Lifetime.
Perspective
Payer.
Interventions
Supplemental ultrasound screening for women with dense breasts following a negative screening mammogram.
Outcome Measures
Breast cancer deaths averted, quality-adjusted life years (QALYs) gained, false positive ultrasound biopsy recommendations, costs, costs per QALY gained.
Results of Base-Case Analysis
Supplemental ultrasound screening after a negative mammogram for women aged 50–74 with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models: 0.14–0.75), gained 1.7 QALYs (0.9–4.7), and resulted in 354 false-positive ultrasound biopsy recommendations (345–421) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325,000 per QALY gained ($112,000-$766,000). Restricting supplemental ultrasound screening to women with extremely dense breasts cost $246,000 per QALY gained ($74,000-$535,000).
Results of Sensitivity Analysis
The conclusions were not sensitive to ultrasound performance characteristics, screening frequency, or starting age.
Limitations
Provider costs for coordinating supplemental ultrasound were not considered.
Conclusions
Supplemental ultrasound screening for women with dense breasts undergoing screening mammography would substantially increase costs while producing relatively small benefits in breast cancer deaths averted and QALYs gained.
Primary Funding Source
National Institutes of Health