WL Gore’s surgical sealant technology for use in gastrectomy procedures was deemed “too expensive” for prophylactic use in preventing post-operative leaks, the primary adverse event (AE) of interest. Existing studies on the cost of leaks were not favorable. The low incidence of the AEs made a prospective study design infeasible, and not diagnostic codes existed for the primary AD of interest. Furthermore, previous definitions of the AE varied and were not validated. TTi assessed the available data, business goals, timeline and budgetary limitations.  A retrospective study using a combination of diagnostic and procedure codes as well as charge code descriptions was designed and implemented to align with customer needs to develop a robust, validated definition of leaks and strong evidence supporting cost-savings. To accomplish this, TTi developed and validated a detailed algorithm for defining leak events in a hospital database. This analysis provided inputs for a high-impact budgetary impact model demonstrating prophylactic use of their sealant technology was a cost-saving strategy. W.L. Gore credits TTi with significantly improving market access for their technology.

http://ibccongress.org/wp-content/uploads/2017/12/leaksgoreposter.pdf