Economic evaluation of endoscopic radiofrequency ablation for the treatment of dysplastic Barrett's esophagus in Spain

ORIGINAL PAPERS Economic evaluation of endoscopic radiofrequency ablation for the treatment of dysplastic Barrett’s esophagus in Spain José Miguel Esteban1, Pedro González-Carro2, Joan B. Gornals3, Carlos Collados4, María Álvarez4, Alejandro Pérez-Mitru5 and Suzan Serip5 Endoscopy Unit. Digestive Department. Hospital Clínico San Carlos. Madrid, Spain. 2Digestive Unit. Complejo Hospitalario La Mancha-Centro. Alcázar de San Juan, Ciudad Real. Spain. 3Digestive Endoscopy Unit. Digestive Department. Hospital Universitari de Bellvitge, IDIBELL. L’Hospitalet de Llobregat, Barcelona. Spain. 4Health Economics & Outcomes Research Department. Medtronic Ibérica, S.A. Madrid, Spain. 5Oblikue Consulting, S.L. Barcelona, Spain 1 Received: 08/06/2017 · Accepted: 10/10/2017 Correspondence: José Miguel Esteban. Endoscopy Unit. Digestive Department. Hospital Clínico San Carlos. Prof Martín Lagos, s/n. 28040 Madrid, Spain. e-mail: ABSTRACT Background and study aims: To assess the cost-effectiveness of introducing endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection in selected patients into the standard of care of Barrett’s esophagus patients with high-grade dysplasia or low-grade dysplasia in Spain. Methods: The disease evolution was modeled via a semi-Markov model. The treatment strategies compared included endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection and the Standard of Care (esophagectomy or palliative chemoradiotherapy according to disease status for high-grade dysplasia and endoscopic surveillance for low-grade dysplasia). Efficacy rates, transition probabilities and utility values were obtained from the literature. Clinical management patterns and resource use were modeled according to Spanish clinical expert opinion. Costs were expressed in euros (€) from 2016 reflecting the Spanish National Health System perspective. Sensitivity analyses were performed to assess the robustness of the model. Results: With respect to the Spanish Standard of Care, endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection was a dominant strategy for high-grade dysplasia patients. When a willingness-to-pay threshold of €30,000 per quality-adjusted lifeyears gained was considered, this was cost-effective for low-grade dysplasia patients (€12,865 per quality-adjusted life-years gained). The sensitivity analyses supported the base case analysis results and pointed towards the main drivers of uncertainty in the model. Conclusions: From a health care decision-maker, endoscopic treatment based on radiofrequency ablation plus endoDisclosures: This study was sponsored by Covidien AG (now a Medtronic company). Oblikue Consulting received a consultancy fee for designing, analyzing and reporting the results of the study. Carlos Collados and María Álvarez are full-time employees of Medtronic Ibérica, S.A. The other authors declare that they have no conflict of interest. REV ESP ENFERM DIG 2018:110(3):145-154 DOI: 10.17235/reed.2017.5087/2017 scopic mucosal resection is the intervention of choice for dysplasic Barrett’s esophagus patients in Spain. Key words: Cost-benefit analysis. Barrett esophagus. Esophageal neoplasms. Catheter ablation. Standard of care. Endoscopy. Esophagectomy. Spain. INTRODUCTION Barrett’s esophagus (BE) is a metaplastic or abnormal change in the cells that line the lower portion of the esophagus, resulting in the replacement of normal stratified squamous epithelium with simple columnar epithelium with globet cells (1). The definition and diagnostic criteria of BE and the histopathological stage classification is difficult and varies worldwide (2,3). However, there is a majority agreement that a pathology report should state the presence or absence of intestinal metaplasia (IM) as well as the endoscopic presence of columnar mucosa of the esophagus (2). Malignant degeneration is thought to occur via a multistep morphological pathway from IM to low-grade dysplasia (LGD), high-grade dysplasia (HGD) and eventually esophageal adenocarcinoma (EAC) (2). Once established, BE does not regress despite the control of gastroesophageal reflux disease symptoms (4) and is considered to be a precancerous condition. The evolutionary stages of the disease may provide an opportunity to intervene prior to the development of EAC (5). The risk of progression of BE within the different stages is also difficult to accurately predict (2,3,6,7). In general, the risk of progression to EAC is lower in BE patients with IM and increases progressively in BE patients with LGD Esteban JM, González-Carro P, Gornals JB, Collados C, Álvarez M, Pérez-Mitru A, Serip S. Economic evaluation of endoscopic radiofrequency ablation for the treatment of dysplastic Barrett’s esophagus in Spain. Rev Esp Enferm Dig 2018;110(3):145-154. DOI: 10.17235/reed.2017.5087/2017 1130-0108/2018/110/3/145-154 • REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS © Copyright 2018. SEPD y © ARÁN EDICIONES, S.L. J. M. Esteban et al. 146 and HGD (2,3,6). The rate of progression of non-dysplastic Barrett esophagus (NDBE) to EAC is estimated to be between 0.1 and 0.5% per year, respectively (8,9). However, in patients with dysplastic Barrett esophagus, the risk of progress to EAC is reported to increase to 10% per year (in patients with HGD) (10). According to the evidence published in the main clinical trials that have evaluated RFA, the mean age of the two cohorts was set at 65 years (range 55-75 years) (1,14,15). The choice of treatment depends on the presence and grade of dysplasia (3,7,10-12). Guidelines agree that endoscopic mucosal resection (EMR) is the optimum therapeutic alternative for early EAC and for HGD with visible, nodular areas. Endoscopic radiofrequency ablation (RFA) is used for flat HGD (3,7,10-12) and esophagectomy is reserved only for patients with EAC that extends into the submucosa (7,11). Consensus documents also recommend endoscopic ablation for BE patients with LGD (2,3,6,7), while the optimum treatment of IM remains unclear and further research is required (2,3,11,12). According to the clinical experts, the SoC for HGD was esophagectomy and endoscopic surveillance once per year for LGD. EMR was thought to precede RFA in 15% of patients (for visible nodular areas). For editing purposes, this procedure is referred to as endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection (RFA-EMR) in the manuscript. BE has a significant economic impact on healthcare systems due to the high prevalence and long-term cost of disease management. The annual treatment costs for BE are estimated at €328 million for a total of 540,131 BE patients diagnosed in Spain (13). The economic burden of BE is expected to rise, due to the increasing incidence over recent decades (14). The direct costs associated with BE include the costs of the physician and hospital visits, the cost of endoscopic procedures and p (...truncated)