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Cost-effectiveness of Digital Breast Tomosynthesis in Population-based Breast Cancer Screening: A Probabilistic Sensitivity Analysis.

ABSTRACT: BackgroundDigital breast tomosynthesis (DBT) is a promising screening test, but its outcomes and cost-effectiveness remain uncertain.PurposeTo determine if biennial DBT is cost-effective in a screening setting, when compared with digital mammography (DM) in the Netherlands, and to quantify the uncertainty.Materials and MethodsIn this study, performed from March 2018 to February 2019, the MIcrosimulation SCreening ANalysis model was used to conduct a probabilistic sensitivity analysis (PSA), consisting of 10 000 model runs with 1 000 000 women simulated per run. The Bayesian Cost-Effectiveness Analysis package and the Sheffield Accelerated Value of Information tool were used to process PSA outcomes. Two simulated cohorts born in 1970 were invited to undergo biennial screening between ages 50 and 74 years-one cohort was assigned to DM screening, and one was assigned to DBT screening. DM input parameters were based on data from the Dutch breast cancer screening program. DBT parameters were based on literature and expert opinion. Willingness-to-pay thresholds of €20 000 ($22 000) and €35 000 ($38 500) per life-year gained (LYG) were considered. Effects and costs were discounted at 3.5% per year.ResultsDBT resulted in a gain of 13 additional life-years per 1000 women invited to screening (7% increase, 13 of 193), followed over lifetime, compared with DM and led to 2% (four of 159) fewer false-positive results. DBT screening led to incremental discounted lifetime effects of 5.09 LYGs (95% confidence interval: -0.80, 9.70) and an increase in lifetime costs of €137 555 ($151 311) per 1000 women (95% confidence interval: €31 093 [$34 202], €263 537 [$289 891]) compared with DM, resulting in a mean incremental cost-effectiveness ratio of €27 023 ($29 725) per LYG. The probability of DBT being more cost-effective was 0.36 at €20 000 and 0.66 at €35 000 per LYG.ConclusionSwitching from digital mammography to biennial digital breast tomosynthesis is not cost-effective at a willingness-to-pay threshold of €20 000 per life-year gained, but digital breast tomosynthesis has a higher probability of being more cost-effective than digital mammography at a threshold of €35 000 per life-year gained.© RSNA, 2020Online supplemental material is available for this article.See also the editorial by Slanetz in this issue.

SUBMITTER: Sankatsing VDV

PROVIDER: S-EPMC7526946 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo evaluate at which sensitivity digital breast tomosynthesis (DBT) would become cost-effective compared to digital mammography (DM) in a population breast cancer screening program, given a constant estimate of specificity.MethodsIn a microsimulation model, the cost-effectiveness of biennial screening for women aged 50-75 was simulated for three scenarios: DBT for women with dense breasts and DM for women with fatty breasts (scenario 1), DBT for the whole population (scenario 2) or maintaining DM screening (reference). For DM, sensitivity was varied depending on breast density from 65 to 87%, and for DBT from 65 to 100%. The specificity was set at 96.5% for both DM and DBT. Direct medical costs were considered, including screening, biopsy and treatment costs. Scenarios were considered to be cost-effective if the incremental cost-effectiveness ratio (ICER) was below €20,000 per life year gain (LYG).ResultsFor both scenarios, the ICER was more favourable at increasing DBT sensitivity. Compared with DM screening, 0.8-10.2% more LYGs were found when DBT sensitivity was at least 75% for scenario 1, and 4.7-18.7% when DBT sensitivity was at least 80% for scenario 2. At €96 per DBT, scenario 1 was cost-effective at a DBT sensitivity of at least 90%, and at least 95% for scenario 2. At €80 per DBT, these values decreased to 80% and 90%, respectively.ConclusionDBT is more likely to be a cost-effective alternative to mammography in women with dense breasts. Whether DBT could be cost-effective in a general population highly depends on DBT costs.Key points• DBT could be a cost-effective screening modality for women with dense breasts when its sensitivity is at least 90% at a maximum cost per screen of €96. • DBT has the potential to be cost-effective for screening all women when sensitivity is at least 90% at a maximum cost per screen of €80. • Whether DBT could be used as an alternative to mammography for screening all women is highly dependent on the cost of DBT per screen.

Project description:BackgroundDigital breast tomosynthesis (DBT) improves breast cancer (BC) detection compared to mammography, however, it is unknown whether this reduces interval cancer rate (ICR) at follow-up.MethodsUsing individual participant data (IPD) from DBT screening studies (identified via periodic literature searches July 2016 to November 2019) we performed an IPD meta-analysis. We estimated ICR for DBT-screened participants and the difference in pooled ICR for DBT and mammography-only screening, and compared interval BC characteristics. Two-stage meta-analysis (study-specific estimation, pooled synthesis) of ICR included random-effects, adjusting for study and age, and was estimated in age and density subgroups. Comparative screening sensitivity was calculated using screen-detected and interval BC data.FindingsFour prospective DBT studies, from European population-based programs, contributed IPD for 66,451 DBT-screened participants: age-adjusted pooled ICR was 13.17/10,000 (95%CI: 8.25-21.02). Pooled ICR was higher in the high-density (21.08/10,000; 95%CI: 6.71-66.27) than the low-density (8.63/10,000; 95%CI: 5.25-14.192) groups (P = 0.03) however estimates did not differ across age-groups (P = 0.32). Based on two studies that also provided data for 153,800 mammography screens (age-adjusted ICR 17.69/10,000; 95%CI: 13.22-23.66), DBT's pooled ICR was 16.83/10,000 (95%CI: 11.89-23.82). Comparative meta-analysis showed a non-significant difference in ICR (-0.44/10,000; 95%CI: -11.00-10.11) and non-significant difference in screening sensitivity (6.79%; 95%CI: -0.73-14.87%) between DBT and DM but a significant pooled difference in cancer detection rate of 33.49/10,000 (95%CI: 23.88-43.10). Distribution of interval BC prognostic characteristics did not differ between screening modalities except that those occurring in DBT-screened participants were significantly more likely to be negative for axillary-node metastases (P = 0.005).InterpretationAlthough heterogeneity in ICR estimates and few datasets limit recommendations, there was no difference between DBT and mammography in pooled ICR despite DBT increasing cancer detection.

Project description:Background Breast Imaging Reporting and Data System (BI-RADS) breast density categories assigned by interpreting radiologists often influence decisions surrounding supplemental breast cancer screening and risk assessment. The landscape of mammographic screening continuously evolves, and different mammographic screening modalities may result in different perception of density, reflected in different assignment of BI-RADS density categories. Purpose To investigate the effect of screening mammography modality on BI-RADS breast density assessments. Materials and Methods Data were retrospectively analyzed from 24 736 individual women (42.3% [10 455 of 24 736] white women, 57.7% [14 281 of 24 736] black women; mean age, 56.3 years; age range, 40.0-74.9 years) who underwent from one to seven mammographic screening examinations from September 2010 through February 2017 (60 766 examinations). Three screening modalities were used: digital mammography alone (8935 examinations); digital mammography with digital breast tomosynthesis (DBT; 30 779 examinations); and synthetic mammography with DBT (21 052 examinations). Random-effects logistic regression analysis was performed to estimate the likelihood of assignment to high versus low BI-RADS density category according to each modality, adjusted for ethnicity, age, body mass index (BMI), and radiologist. The interactions of modality with ethnicity and BMI on density categorization were also tested with the model. Results Women screened with DBT versus digital mammography alone had lower likelihood regarding categorization of high density breasts (digital mammography and DBT vs digital mammography: odds ratio, 0.69 [95% confidence interval: 0.61, 0.80], P < .001; synthetic mammography and DBT vs digital mammography: odds ratio, 0.43 [95% confidence interval: 0.37, 0.50], P < .001). Lower likelihood of high density was also observed at synthetic mammography and DBT compared with digital mammography and DBT (odds ratio, 0.62; 95% confidence interval: 0.56, 0.69; P < .001). There were interactions of modality with ethnicity (P = .007) and BMI (P = .003) on breast density assessment, with greater differences in density categorization according to modality observed for black women than for white women and groups with higher BMI. Conclusion Breast density categorization may vary by screening mammographic modality, and this effect appears to vary by ethnicity and body mass index. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Philpotts in this issue.

Project description:ImportanceMany US radiologists have screening mammography recall rates above the expert-recommended threshold of 12%. The influence of digital breast tomosynthesis (DBT) on the distribution of radiologist recall rates is uncertain.ObjectiveTo evaluate radiologists' recall and cancer detection rates before and after beginning interpretation of DBT examinations.Design, setting, and participantsThis cohort study included 198 radiologists from 104 radiology facilities in the Breast Cancer Surveillance Consortium who interpreted 251?384 DBT and 2?000?681 digital mammography (DM) screening examinations from 2009 to 2017, including 126 radiologists (63.6%) who interpreted DBT examinations during the study period and 72 (36.4%) who exclusively interpreted DM examinations (to adjust for secular trends). Data were analyzed from April 2018 to July 2019.ExposuresDigital breast tomosynthesis and DM screening examinations.Main outcomes and measuresRecall rate and cancer detection rate.ResultsA total of 198 radiologists interpreted 2?252?065 DM and DBT examinations (2?000?681 [88.8%] DM examinations; 251?384 [11.2%] DBT examinations; 710?934 patients [31.6%] aged 50-59 years; 1?448?981 [64.3%] non-Hispanic white). Among the 126 radiologists (63.6%) who interpreted DBT examinations, 83 (65.9%) had unadjusted DM recall rates of no more than 12% before using DBT, with a median (interquartile range) recall rate of 10.0% (7.5%-13.0%). On DBT examinations, 96 (76.2%) had an unadjusted recall rate of no more than 12%, with a median (interquartile range) recall rate of 8.8% (6.3%-11.3%). A secular trend in recall rate was observed, with the multivariable-adjusted risk of recall on screening examinations declining by 1.2% (95% CI, 0.9%-1.5%) per year. After adjusting for examination characteristics and secular trends, recall rates were 15% lower on DBT examinations compared with DM examinations interpreted before DBT use (relative risk, 0.85; 95% CI, 0.83-0.87). Adjusted recall rates were significantly lower on DBT examinations compared with DM examinations interpreted before DBT use for 45 radiologists (35.7%) and significantly higher for 18 (14.3%); 63 (50.0%) had no statistically significant change. The unadjusted cancer detection rate on DBT was 5.3 per 1000 examinations (95% CI, 5.0-5.7 per 1000 examinations) compared with 4.7 per 1000 examinations (95% CI, 4.6-4.8 per 1000 examinations) on DM examinations interpreted before DM use (multivariable-adjusted risk ratio, 1.21; 95% CI, 1.11-1.33).Conclusions and relevanceIn this study, DBT was associated with an overall decrease in recall rate and an increase in cancer detection rate. However, our results indicated that there is wide variability among radiologists, including a subset of radiologists who experienced increased recall rates on DBT examinations. Radiology practices should audit radiologist DBT screening performance and consider additional DBT training for radiologists whose performance does not improve as expected.

Project description:INTRODUCTION:Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. METHODS AND ANALYSIS:80?000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2?years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. ETHICS AND DISSEMINATION:This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals. TRIAL REGISTRATION:NCT03377036; Pre-results.

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Cost-effectiveness of Digital Breast Tomosynthesis in Population-based Breast Cancer Screening: A Probabilistic Sensitivity Analysis.

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