Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective

Background: Mastectomy or breast conserving surgery, both with axillary lymph node dissection, are common treatments for early-stage breast cancer. Monopolar electrocautery is typically used for both procedures, despite evidence of improved clinical outcomes with HARMONIC FOCUS™+. This analysis evaluated the budget impact of adopting HARMONIC FOCUS™+ versus monopolar electrocautery for patients undergoing these procedures from an Italian hospital perspective. Methods: Total costs for an annual caseload of 100 patients undergoing mastectomy or breast conserving surgery, with axillary lymph node dissection, with either the intervention or comparator were calculated. Italian clinical and cost input data were utilised. The analysis included costs for the device, operating room time, postoperative length of stay, treating seroma and managing postoperative chest wall drainage. Deterministic and probabilistic sensitivity analyses assessed uncertainty of model input values. Two scenario analyses investigated the impact of conservative estimates of postoperative length of stay reduction and daily hospital cost on the simulated cost difference. Results: HARMONIC FOCUS™+ achieves annual savings of EUR 100,043 compared with monopolar electrocautery, derived from lower costs for operating room time, postoperative length of stay and seroma and postoperative chest wall drainage management, offsetting the incremental device cost increase (EUR 43,268). Cost savings are maintained in scenario analyses and across all variations in parameters in deterministic sensitivity analysis, with postoperative hospital stay costs being key drivers of budget impact. The mean (interquartile range) cost savings with HARMONIC FOCUS™+ versus monopolar electrocautery in probabilistic sensitivity analysis are EUR 101,637 (EUR 64,390–137,093) with a 98% probability of being cost saving. Conclusions: The intervention demonstrates robust cost savings compared with monopolar electrocautery for mastectomy or breast conserving surgery, with axillary lymph node dissection, in an Italian hospital setting, and improved clinical and resource outcomes. These findings, with other clinical and cost analyses, support HARMONIC FOCUS™+ use in this setting.