Wire-Free, Nonradioactive Localization Techniques to Guide Surgical Excision of Nonpalpable Breast Tumours: A Health Technology Assessment.

Background: The current standard treatment for nonpalpable breast tumours is surgical excision; however, it is nearly impossible to locate these small masses during surgery. Therefore, a marker must be implanted into the abnormal tissue under mammography or ultrasound guidance prior to surgery to guide the surgeon to the location of the tumour. Two techniques to localize nonpalpable breast tumours are currently used in Ontario: wire-guided localization and radioactive seed localization.However, these techniques have some limitations. New wire-free, nonradioactive technologies that address these limitations are now available. We conducted a health technology assessment of wire-free, nonradioactive localization techniques available in Canada that are used to localize nonpalpable breast tumours for surgical excision. This report includes an evaluation of the effectiveness, safety, and budget impact of publicly funding these techniques, as well as an evaluation of patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBINS-I tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search, and we analyzed the budget impact of publicly funding wire-free, nonradioactive localization techniques to guide surgical excision of nonpalpable breast tumours in Ontario. We did not conduct a primary economic evaluation because of the limited data available to use as model inputs. To contextualize the potential value of wire-free, nonradioactive localization techniques, we spoke with people who had undergone a localization procedure for the surgical excision of a nonpalpable breast tumour.

Results: We included 16 studies in the clinical evidence review, of which 15 were comparative studies and one was a single-arm study. The results of our analysis of the comparative studies suggest that the re-excision rate for the wire-guided, nonradioactive devices included in this review is either lower or not different from the rate for conventional localization methods (GRADE: Moderate/Low). We found no difference in postoperative complications or operation time between the new and the conventional techniques (GRADE: Moderate). In a feasibility study of a newly developed magnetic seed device in Ontario, no patient required re-excision (GRADE: not assessed). Our economic evidence review identified two costing studies that found that wire-free, nonradioactive localization techniques were more expensive than wire-guided and radioactive seed localization. We were unable to identify any published cost-effectiveness evidence for wire-free, nonradioactive localization techniques. The annual budget impact of publicly funding wire-free, nonradioactive localization techniques in Ontario over the next 5 years ranges from an additional $0.51 million in year 1 to an additional $2.61 million in year 5, for a total 5-year budget impact of $7.73 million. The people we spoke with who had undergone a localization procedure reported valuing surgical interventions that are clinically effective, timely, and patient centred. They responded positively to the potential public funding of wire-free, nonradioactive localization techniques and felt that equitable access should be a requirement of implementation.

Conclusions: The wire-free, nonradioactive localization techniques included in this review are effective and safe methods for the localization of nonpalpable breast tumours and are reasonable alternatives to wire-guided and radioactive seed localization. We estimate that publicly funding wire-free, nonradioactive localization techniques in Ontario would result in an additional cost of $7.73 million over the next 5 years. Broad access to wire-free, nonradioactive localization techniques may have a positive impact on patients undergoing surgical excision for a nonpalpable breast tumour. People with lived experience of a localization procedure value surgical interventions that are clinically effective, timely, and patient centred. They also value equitable access to surgical care.