Benefits, Harms, and Cost-Effectiveness of Supplemental Ultrasonography Screening for Women With Dense Breasts

Abstract

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

Qualitative Versus Quantitative Mammographic Breast Density Assessment: Applications for the US and Abroad

“…An analysis of the cost effectiveness of screening ultrasound for women with dense breasts by Sprague et al [112] measured breast cancer deaths averted, quality-adjusted life years gained (QALY), false positives, costs, and costs per QALY gained. When reviewing the age group of 50–74, supplemental screening ultrasound averted 0.36 additional breast cancer deaths; gained 1.7 QALYs, and resulted in 354 false-positive biopsy recommendations.…”

Risk-based Breast Cancer Screening

“…37 In a comparative modeling study, researchers found that adding ultrasound averted 0.36 additional breast cancer deaths but resulted in 354 unnecessary benign biopsies per 1,000 women screened. 37 Even though the comparative weighting of relatively rare benefits of deaths prevented and more common risks such as benign biopsies is somewhat subjective, researchers concluded that adding ultrasound to digital mammography screening likely causes more harm relative to benefits gained.…”

Population-Based Precision Cancer Screening: A Symposium on Evidence, Epidemiology, and Next Steps

“…Certain published analyses that aimed to identify subgroups for whom screening before age 50 was beneficial suggest that women with extremely dense breasts may benefit from beginning screening in their forties (13) and by choosing an annual rather than biennial interval (14). No direct evidence supports use of supplemental ultrasound or MRI in the general population of women with dense breasts, although modeling studies suggest that supplemental ultrasound following a negative mammogram may increase cancer detection but at the cost of substantially increased false-positive rates (15). Over 90 genetic susceptibility loci have been identified (7), but common genetic variants or polygenic risk scores are yet to be incorporated into screening recommendations; statistical modeling suggests, though, that they could decrease the number needed to screen while preserving the ability to identify most currently screen-detectable cancers (9).…”