Economic Evaluation of Cytosponge®-Trefoil Factor 3 for Barrett's Oesophagus: A Cost-Utility Analysis

Abstract

Background: Oesophageal adenocarcinoma (EAC) has a very poor prognosis unless detected early. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett’s oesophagus, a precursor of EAC. Randomised controlled trial data from the BEST3 trial has shown that an offer of Cytosponge-TFF3 in the primary care setting in England to individuals on medication for acid reflux increases detection of Barrett’s oesophagus 10-fold over a year compared with the standard of care, which entails referral for an endoscopy if deemed necessary by the primary care physician. The aim of this study was to conduct an economic evaluation of Cytosponge-TFF3 screening versus usual care using data from the BEST3 trial.Methods: A Markov model with a one-year cycle-length and a lifetime time horizon was constructed. The impact of one round of Cytosponge screening was modelled in patients taking medication for reflux symptoms with an average age of 69 years. Outcomes and costs were taken from trial data and published sources. Utilities were derived from the literature. The incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were conducted on model parameters.Findings: Per person, one round of Cytosponge-TFF3 screening, including confirmatory endoscopy and treatment, in the intervention arm costed £91 more than usual care and generated an additional 0·015 quality-adjusted life-years (QALYs) at an ICER of £6027 per QALY gained. Probabilistic sensitivity analysis gave an ICER of £5694 (95% CI -£11 816-£22 672). At a willingness-to-pay threshold of £20 000 per QALY, the probability that Cytosponge-TFF3 was cost-effective was over 90%. Deterministic sensitivity analysis suggested that the utility of ‘No Barrett’s oesophagus’ and ‘Low-grade dysplasia’, the starting age of patients screened, the uptake rate and cost of Cytosponge-TFF3, and the prevalence of Barrett’s oesophagus had the greatest impact on the cost-effectiveness of the model: across all the deterministic sensitivity analysis scenarios, the ICER was at most £11 255 per QALY gained.Interpretation: A one-off Cytosponge-TFF3 screen is cost-effective relative to usual care for patients with gastro-oesophageal reflux disease in the UK. Improving Cytosponge-TFF3 uptake and targeting younger patients is likely to further improve cost-effectiveness.Funding Statement: Cancer Research UK funded the BEST3 trial, National Institute for Health Research, the UK National Health Service, Medtronic and the Medical Research Council.Declaration of Interests: RCF is named on patents related to Cytosponge-TFF3 and biomarker assays which have been licensed by the Medical Research Council to Covidien (now Medtronic); RCF is also a shareholder and consultant for Cyted Ltd. All other authors have no conflict of interest to declare.