A Cost Effectiveness Analysis (CEA) of Lower Esophageal Sphincter (LES) Electrical Stimulation Therapy (EST), Laparoscopic Fundoplication (LF) and Proton Pump Inhibitor (PPI) Therapy for Management of Refractory GERD

Abstract

Purpose: Management of patients with refractory GERD remains unsatisfactory. Recent trials of LES-EST (EndoStim® LES Stimulator, EndoStim BV, Netherlands) has been encouraging (Am J Gastro 2011; 106: S6). LES-EST offers a minimally invasive, safe and effective treatment for GERD. We performed a CEA of LES-EST for the long-term management of refractory GERD. Methods: In a third-party-payer perspective Markov decision analysis model, in a cohort of refractory GERD patients (incomplete symptom response on bid PPI) 3 mutually exclusive, competing strategies were examined. Strategy I, patients followed on bid PPI, no additional intervention; Strategy II and III the patients were managed with LF or LES-EST, respectively. Discounted cost and utility values for long-term PPI therapy and LF were obtained from published information; for LES-EST, data were obtained from the results of the recent trials and when definite data (such as durability of response) was not available, uncertainty analyses were incorporated using second order Monte Carlo and threshold analyses. Incremental Cost-Effectiveness Ratio (ICER) of different strategies was the main outcome measure, the model time horizon was 10 years given that published information on outcomes of LF is limited to 10 years and the minimum battery life of the stimulator is 10 years. The model was biased against LES-EST by incorporating the most favorable reported rates of primary success, complication and durability of LF. Results: In the baseline analysis, LES-EST (strategy III) dominated LF (strategy II), while ICER of bid PPI (strategy I) was > $90K per QALY (Table). Compared to LF, odds ratio of being completely off PPI with LES-EST was 5.8 (95% CI, 5.4-6.2). Threshold analyses showed cost of PPI and EndoStim® LES stimulator, and % patients in the cohort with incomplete control of GERD symptoms on PPI are the critical determinants of CEA of LES-EST.Table: Cost effectiveness analysisConclusion: LES-EST for management of refractory GERD is dominant strategy (less costly and more effective) compared to LF and is the preferred strategy compared to PPI in long-term cost-effectiveness. Longer-term clinical data on LES-EST is needed to conclusively establish its effectiveness for the treatment of refractory GERD.Figure: [1511] Sensitivity analysis (2-way) comparing cost of LES-EST with cost of LF with star showing coordinates of baseline estimates.Disclosure: A. Das - Grant/Research Support. L. Rodriguez - Grant/Research Support. P. Siersema - Grant/Research Support. This research was supported by an industry grant from EndoStim, BV, The Hague, Netherland.