Budget Impact Analysis of Vacuum-Assisted Excision Versus Surgical Excision for the Assessment of Breast Lesions of Uncertain Malignant Potential in Italy

Background/Objective: B3 breast lesions, of uncertain malignant potential, pose diagnostic challenges due to their intermediate malignancy risk. While surgical excision (SE) is traditionally used for definitive diagnosis, vacuum-assisted excision (VAE) offers a less invasive alternative. As diagnostic practices evolve, this study assesses the financial impact of adopting VAE for B3 lesion management from the hospital perspective within the Italian healthcare system. Materials and Methods: A budget impact analysis (BIA) was conducted from the hospital perspective over a five-year time horizon. Clinical complication rates for SE and VAE were derived through a systematic literature review and meta-analysis. A micro-costing approach was used to estimate direct medical costs, based on detailed resource utilization data collected via structured questionnaires administered across five Italian hospitals. One-way sensitivity analyses and scenario analyses were conducted to test the robustness of the results. Results: VAE was associated with significantly lower costs than SE, mainly due to reduced hospitalization, operating room use, and personnel time. The average per-patient cost was 820€ for VAE versus 1,663€ for SE, yielding savings of 843€. Over five years, with VAE adoption rising from 20% to 80%, cumulative hospital savings were estimated to be between €11.1 million and €13.7 million. These findings were further confirmed by multiple budget impact scenario analyses, which consistently demonstrated a favorable economic profile for VAE across all tested assumptions. Conclusion: In our analysis, VAE represented a cost-saving, minimally invasive alternative to SE for the management of B3 breast lesions from the hospital perspective in Italy. Its adoption can enhance hospital efficiency and support more sustainable resource allocation within the Italian healthcare system.