Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.

Effectiveness of localization in terms of lesion identification (did the localization, based on the pathological report, allow the lesion to be located in the breast?)

• Rate of clear margins (for isolated in situ lesions: margin ≥ 2 mm, and for invasive cancers: non-zero margin)
• Percentage of patients requiring re-intervention due to an unclear margin
• Measured distance between the marker and the target lesion during the procedure
• Ratio between the weight of the resected specimen and the lesion size in g/mm²
• Patient satisfaction with their care, assessed using a 5-point Likert scale during the postoperative consultation (between day 15 and day 30 after resection)
• Radiologist satisfaction with the marker placement, assessed using a 5-point Likert scale immediately after placement
• Surgeon satisfaction with lesion localization, assessed using a 5-point Likert scale at the end of the surgery.

Quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L).The questionnaire assesses 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression). Each dimension is rated on 5 levels (from 1 = no problems to 5 = extreme problems).

Questionnaire to evaluate the satisfaction of radiologist after the maker placement and questionnaire to evaluate the satisfaction of surgeon after the surgery. The score isn't on a scale.

Questionnaire after the surgery to evaluated the patient satisfaction and experience. The score isn't on a scale.

The decision to include a Budget Impact Analysis (BIA) in this study is in line with the framework agreement signed in January 2016 between the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé - CEPS, in French) and the Pharmaceutical Industry (Les Entreprises du Médicament - LEEM, in French), which advises the implementation of a BIA in addition to the medico-economic study. The BIA will strictly comply with the HAS requirements presented in its methodological guide for BIA.

A budget impact model (BIM) will be developed with the French National health insurance perspective. The cost of the current (hookwire) or new intervention (magnetic clip) mix will be assessed. The population to be included in a BIA will be all patients eligible in France for the new intervention during the time horizon of 3 years. The results will be expressed in incremental budget impact in the first, second and third year.

The organizational analysis will be based on performance indicators of magnetic clips compared to metallic wires, such as the number of patient visits to the hospital before surgery, the number of localization procedures performed on the day of the intervention, the length of stay, waiting times, and the number of emergency visits throughout the follow-up period. The stochastic variables (lengths of stay, intervals between stays) will be modeled using appropriate statistical distributions, determined by maximum likelihood estimation based on statistical analyses of the extracted data.