Abstract

Prognosis of Barret’s esophagus (BE) is generally good, although malignant progression may occur in a small number of patients from non-dysplastic BE (NDBE), to low-grade dysplasia (LGD), high-grade dysplasia (HGD), and eventually esophageal adenocarcinoma (EAC). Radiofrequency ablation (RFA) is an established endoscopic technique recommended for eradication of BE. The aim of this analysis was to evaluate the cost-effectiveness of treating HGD patients with RFA in Italy. The analysis considered the Italian NHS perspective and the whole patients’ lifetime. Model structure was a Discrete-time Markov Model representing patients’ transition from NDBE, LGD, HGD and EAC. In the model, HGD patients are treated with either RFA (with endoscopic mucosal resection in selected patients) or esophagectomy, whereas LGD patients only receive endoscopic surveillance. Successfully operated patients move to a “cured” health-state and can progress again in the future. All patients with resecable EAC receive esophagectomy and are assumed free of relapse thereafter. Clinical and epidemiological inputs were derived from the published literature and expert opinions; Quality adjusted life years were used as primary health outcome. Cost data were derived using either micro-costing or national tariffs. Lastly, model structure, parameters and assumptions were validated by 5 prominent clinicians in Italy. Treating HGD patients with RFA in Italy was more effective and less expensive, compared to the standard of care. Probabilistic sensitivity analysis showed >95% of probability of RFA being the optimal strategy at a €20,000 threshold. This analysis showed that RFA is a dominant strategy for HGD patients in Italy. Italy has recently launched a National Plan for HTA of Medical Devices, setting criteria and procedures for determining coverage and reimbursement decisions for medical devices. Cost-effectiveness will play an increasing role as decision rule in the future requiring more studies to prove value for money of emerging technologies.

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