Economic evaluation of vacuum assisted excision for the management of breast biopsies

Principal investigators: Carla Rognoni  

Team UB/Cergas: Carla Rognoni – Rosanna Tarricone – Ludovico Cavallaro

Client: Becton Dickinson Italia S.p.A.

Duration: 10 months

Abstract:

A breast biopsy is a diagnostic procedure performed to investigate abnormalities in breast tissue identified during physical examinations or imaging studies. This approach is particularly valuable for evaluating B3 breast lesions, which are classified as "of uncertain malignant potential." These lesions are not definitively benign yet do not meet the criteria for malignancy.

A procedure known as Vacuum-Assisted Excision (VAE) has emerged as a pivotal tool for managing B3 breast lesions. Recent international guidelines recommend considering VAE, alongside standard surgical breast biopsy, as part of the management strategy for these lesions. Following a core-needle biopsy, the choice between VAE and surgical excision should be determined collaboratively by a multidisciplinary team and the patient, ensuring a personalized approach to care.

The advantages of VAE include shorter recovery time, reduced scarring, quicker resumption of daily activities, and minimal post-procedure pain and discomfort compared to surgical excision. Moreover, early evidence from the UK has demonstrated cost savings associated with VAE relative to surgical excision.

The objective of this project is to generate insights into the clinical and economic implications of breast biopsy methods to aid national stakeholders in Italy in evaluating options comprehensively. Specifically, the primary goal is to estimate the clinical and economic impact of performing biopsies using VAE in comparison with the current "standard of care" (SOC), which involves surgical excision. Additionally, the research aims to assess patient preferences for biopsy procedures based on characteristics that define an ideal approach.

Methods:

A micro-costing evaluation and a budget impact assessment from the hospital perspective in Italy, will be performed considering the appropriate diffusion of the use of VAE compared to the SOC. The preliminary phase of the study will involve a comprehensive literature review to identify clinical and economic evidence on the use of VAE versus SOC in managing B3 breast lesions.

Patient preferences will be evaluated through a discrete choice experiment (DCE). This methodology will be employed to explore patient preferences for various characteristics of a hypothetical diagnostic approach for breast cancer, such as procedure duration, type of scarring, recovery time, and other relevant attributes.