Economic evaluation of Cytosponge®-trefoil factor 3 for Barrett esophagus: A cost-utility analysis of randomised controlled trial data

Abstract

Background Esophageal adenocarcinoma has a very poor prognosis unless detected early. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett esophagus, a precursor of esophageal adenocarcinoma. 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 esophagus 10-fold over a year compared with standard care. This is an economic evaluation of Cytosponge-TFF3 screening versus usual care using data from the BEST3 trial which took place between 20th March 2017 and 21st March 2019. Methods A Markov model with a one-year cycle-length and a lifetime time horizon was created, adapting previous modeling work on Cytosponge screening. The impact of one round of Cytosponge screening was modelled in patients with a median age of 69 years (based on BEST3 trial population). Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). 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 £82 more than usual care and generated an additional 0.015 quality-adjusted life-years (QALYs) at an ICER of £5,500 per QALY gained. Probabilistic sensitivity analysis gave an ICER of £5,405 (95% CI -£6,791 to £17,600). The average QALY gain per person is small because the majority of patients in the model will not develop BE and therefore will have no resulting change in their utility, however the small proportion of patients who are identified with BE dysplasia or cancer derive large benefit. At a willingness-to-pay threshold of £20,000 per QALY, the probability that Cytosponge-TFF3 was cost-effective was over 90%. Interpretation Using data from a pragmatic randomised trial, one-off Cytosponge-TFF3 screen is cost-effective relative to usual care for patients with gastro-esophageal reflux disease, despite relatively low uptake and an older population in this trial setting than previously modelled. Improving Cytosponge-TFF3 uptake and targeting younger patients is likely to further improve cost-effectiveness.

Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

“…In addition, it was shown that the interpretation of TFF3 positivity could be performed in an automated manner, thereby significantly reducing pathologist workload [39]. Further, modelling studies suggest Cytosponge TFF3-based screening to be cost-effective when used on a hypothetical population of white individuals aged ≥ 50 years with acid reflux symptoms [40,41].…”

Cellulose Sponge, the Detector of Esophageal Cancer: Innovation for Early Detection of Esophageal Cancer without Biopsy?: A Mini Review

“…In another study, the cytosponge segment size of 2 cm had a sensitivity of 90% with a specificity of 93.5% [16]. This includes the factor that there is no repetition of diagnostic procedures in examinations [14].…”

“…In another research showed gastric pain 11%, nausea or vomiting 6%, voice disturbance 3%, diarrhea or upset stomach 4%, and 1% serious adverse events such as unconsciousness and detachment of the sponge on day of the procedure. The failure to make the patient swallow CaSPER again was 19%, this was because there were no distal esophageal cells when removed [14].…”

“…The cost-effective cytosponge is seen from the cost incurred for one diagnostic, which is $107 with an incremental cost-effectiveness ratio (ICER) of $7184 per quality-adjusted life-years (QALY) [14]. The cost of endoscopic biopsy for esophageal cancer is ICER $52,483 per QALY and assay cost per test is $1475, endoscopy with biopsy is $2038, with a range of $760-$3750 [17].…”

Prognostic impact of deprivation on esophagogastroduodenoscopy outcome

“…Low socio-economic status has been highlighted as a potential barrier to uptake of these new screening technologies due to lower levels of health literacy [19] . However, none of the current trials have included a detailed, individualised evaluation of multiple deprivation scores and the subsequent impact [20,21] A lack of association between cancer and deprivation in this study may be influenced by the overall low incidence of cancer detection in this unselected cohort of patients.…”