The Clinical and Economic Effects of Hemo-Clips for High-Risk Bleeding Ulcers: Are They Likely to Be Worth the Money?

Abstract

Background: Data suggest that dual therapy with epinephrine and bipolar electrocoagulation is superior to epinephrine alone in high-risk bleeding peptic ulcers. In the last several years, however, mechanical hemostasis with endoscopic clipping devices has become increasingly popular. Yet, the added cost of widespread use of clips can only be justified if they also provide added benefit to patients by reducing ulcer rebleeding risk. The purpose of this study was to quantify the minimum incremental reduction in ulcer rebleeding risk needed to make a triple therapy approach with epinephrine, bipolar electrocoagulation, and clipping, cost-effective by traditional standards (<$50,000 per life-year saved). Methods: A simple mathematical model was developed to compare triple therapy to traditional dual therapy for high-risk bleeding peptic ulcers. The published literature was used to estimate risks, benefits, and costs. The model assumed that: (1) the rebleeding risk for high-risk lesions was 12% (range 5%-20%); (2) the risk of mortality from rebleeding was 12% (5%-20%); (3) the added cost of clip-based therapy was $600 per endoscopy ($300-$900); and, (4) the cost of ulcer rebleeding was $4000 ($1,000-$20,000). We calculated the minimum incremental relative risk reduction (RRR) required for triple therapy to cost less than $50,000 per life-year saved (LYS). Results: In the base-case analysis, the cost-effectiveness threshold (<$50,000 per LYS) for the triple therapy approach was achieved at a RRR for rebleeding of 5% or greater. In sensitivity analysis, this result proved to be sensitive to the overall rebleeding risk and the mortality from rebleeding, though the RRR of triple therapy required to meet the cost-effectiveness threshold remained ≤10% even in the worst-case scenario. Conclusions: To meet traditional criteria for cost-effectiveness, triple therapy need only demonstrate a small incremental reduction in rebleeding risk over traditional dual therapy. In the future, adequately powered studies should compare triple therapy to dual therapy in patients with high-risk bleeding peptic ulcers.