Assessing New Technologies in Surgery: Case Example of Acute Primary Repair of the Thumb Ulnar Collateral Ligament.

PURPOSE Health technology assessment provides a means to assess the technical properties, safety, efficacy, cost-effectiveness, and ethical/legal/social impact of a novel technology. An important component of health technology assessment is the cost-effectiveness analysis (CEA), which can be performed using model-based CEA. This study used the CEA model to compare the cost-effectiveness of a novel ligament augmentation device with the standard technique for primary repair of complete ulnar collateral ligament (UCL) tears. METHODS A model was developed for complete UCL tear requiring acute surgical repair, comparing the cost-effectiveness of standard technique primary repair and repair using a ligament augmentation device from a societal perspective. Primary outcomes included quality-adjusted life years (QALYs), cost, net monetary benefit (NMB) and incremental NMB. A cost-effectiveness threshold of CAD $50,000/QALY was used to compare the 2 techniques. Sensitivity analyses were conducted to assess the parameter uncertainty, specifically the impact of device cost, time off work, probability of complication, and postoperative outcome. RESULTS The NMB for the standard technique was CAD $42,598, and the NMB for repair using the ligament augmentation device was CAD $41,818. The standard technique was the preferred strategy for primary repair of complete UCL tears. One-way sensitivity analyses demonstrated that the ligament augmentation device became cost-effective if individuals return to work in <18 days (base case 23 days). The device was also favored when the cost was less than CAD $50 and the difference in time to return to work was at least 1 day. CONCLUSIONS Our model demonstrates that there may be significant costs associated with the introduction of novel health technologies, and certain conditions, such as an earlier return to work, must be met for some devices to be a cost-effective option. This study provides an example of how model-based CEA is a useful tool to assess the cost-effectiveness of a novel device. TYPE OF STUDY/LEVEL OF EVIDENCE Economic/Decision Analysis II.