Authors' objectives: The objective of this single technology assessment (STA) is to assess the efficacy, safety, and cost-effectiveness of digital breast tomosynthesis in breast cancer screening in Norway. There are several manufacturers of DBT systems, but only Hologic Inc., has to date (June 2017) submitted a documentation pack. We have performed a single technology assessment of the use of Hologic Selenia Dimensions digital mammography system for breast cancer screening, based on the submission from Hologic Inc. We do not cover the use of the system in the diagnosis of breast cancer in clinical practice by this STA.

Authors' results and conclusions: Clinical effectiveness. Our main findings are as follows: We are uncertain whether Hologic digital breast tomosynthesis in combination with digital mammography or synthesised digital mammography decreases or increases recall rates compared to digital mammography alone (very low confidence due to conflicting evidence from observational studies). The intervention may increase the rate of screening-detected cancer (cancer detection rate (CDR) according to all studies (very low confidence due to sparse evidence from one observational study). We are uncertain whether Hologic digital breast tomosynthesis in combination with digital mammography or synthesised digital mammography makes any difference with regard to the detection of interval cancer compared to digital mammography alone (very low confidence in the evidence due to sparse evidence from one observational study). We are uncertain whether Hologic digital breast tomosynthesis in combination with digital mammography or synthesised digital mammography decreases or increases false positive rates compared to digital mammography alone (very low confidence due to conflicting evidence from observational studies). The intervention may provide similar sensitivity rates, but may increase specificity rates (low confidence due to evidence from observational studies). We are uncertain whether Hologic digital breast tomosynthesis in combination with digital mammography or synthesised digital mammography decreases or increases false negative rates compared to digital mammography alone (very low confidence due to sparse evidence from one observational study). Information on death and quality of life was not reported. Uncertainty regarding the effect estimates means that new research may alter the results and our conclusion. Radiation dose and risk assessment When compared to the current practice with DM, introducing the Hologic Selenia Dimensions DBT-system into the Norwegian Breast Cancer Screening Programme (NBCSP) will result in an increased radiation dose followed by an increased risk of radiation-induced cancer for all the evaluated interventions defined by the PICO. Summary of findings based on doses reported in the OTST and STORM-2 trial: DBT only: The dose and risk will increase by 23% to 38%, resulting in a total absorbed dose to granular tissue (AGD) of 3.7-3.9 mGy and an estimated incidence of radiation-induced breast cancer of 15 to 16 per 100,000 women and mortality of 1.2 per 100,000 women. DBT + DM: The dose and risk will increase by a factor of between 2.23 and 2.37, resulting in a total AGD of 6.4-7.0 mGy and an estimated incidence of radiation-induced breast cancer of 26 to 29 per 100,000 women and mortality of 2.1 to 2.3 per 100,000 women . DBT + S2D: The dose and risk will be increased by 23% to 38%, but reduced by 42% t0 45% compared to DBT + DM, resulting in the same dose and risk as DBT alone. The estimated values for incidence of radiation-induced breast cancer and mortality must be interpreted with caution as there is a high level of uncertainty associated with them. However, the ratio between doses and risks for the different interventions provides valid input to the total risk-benefit evaluation to be done for the screening program. Cost-effectiveness: The base case results of the submitted economic analysis of DBT+DM (S2D) vs. DM alone were 0,007 quality adjusted life years gained per woman screened. The incremental cost per QALY gained was approximately NOK 144 000. This result is estimated for a population of women with dense breasts. Hologic based the budget impact analysis on three components: relative costs of equipment procurement, screening costs, and breast cancer treatment costs. The base case estimate was a net increase in expenditure of 77.5 million NOK in year 5 after implementation. Hologic also included sensitivity analysis in the budget impact analysis to determine the effect of varying the price, which has yet to be determined, of the DBT equipment, and to examine how changes in important assumptions would influence the results of the budget impact analysis. The net increase in expenditure reported varied significantly in the sensitivity analyses. Conclusion: There is too little evidence to conclude regarding the effects of the use of Hologic digital breast tomosynthesis in combination with digital mammography or synthesised digital mammography compared to digital mammography alone for the outcomes assessed in our report (recall rates, cancer detection rate, interval cancer rate, false positive and false negative rate, sensitivity, specificity, mortality and quality of life). Preparation of a full health technology assessment should be considered when sufficient evidence is available.

Project Status: Completed

Year Published: 2017

URL for published report: https://www.fhi.no/en/publ/2017/digital-brysttomosyntese-med-hologic-3d-mammograf--selenia-dimensions-syste/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo