SeHCAT (tauroselcholic [75selenium] acid) for the investigation of bile acid diarrhoea in adults: a systematic review and cost-effectiveness analysis

Background Tauroselcholic [ 75 selenium] acid (SeHCAT™) (GE Healthcare, Chicago, IL, USA) is a radiopharmaceutical that may be useful in diagnosing bile diarrhoea. Objectives To assess the clinical effectiveness and cost-effectiveness of SeHCAT for investigation adults with chronic unexplained diarrhoea, diarrhoea-predominant irritable bowel syndrome or functional diarrhoea (suspected primary diarrhoea), Crohn’s disease who have not undergone ileal resection secondary diarrhoea). Methods Sixteen databases were searched to November 2020. The review process included measures minimise error bias. Results summarised by study quality was considered. analysis combined short-term (6-month) decision-analytic model (diagnosis initial treatment response) lifetime Markov comprising three health states (diarrhoea, no death), transitions determined probabilities response treatment. Analyses conducted from an NHS Personal Social Services perspective. Twenty-four studies this review. Of these, 21 observational studies, reporting some outcome data patients treated sequestrants, which only positive test offered sequestrants. median rate among 7-day retention value ≤ 15%, 68% (range 38–86%) (eight studies). estimated sensitivity (≤ 15% threshold) predict colestyramine 100% (95% confidence interval 54.1% 100%) specificity estimate 91.2% 76.3% 98.1%) (one study). proportion intolerant/discontinued sequestrants 4–27%) There insufficient information determine whether intolerance varied between colestyramine, colestipol colesevelam. For both populations, (i.e. 15%) strategy dominated other strategies resulted incremental ratios < £20,000–30,000 per quality-adjusted life-year gained. suspected population, most likely cost-effective: 67% 73% probability at threshold £20,000 £30,000 gained, respectively. these 89% 92% Cost-effectiveness mostly led response. highest majority scenarios explored. Limitations conclusions lack evidence linking use testing patient-relevant outcomes. optimal threshold, define select uncertain. It unclear ‘borderline’ ‘equivocal’ values (e.g. 10% > could benefit Although results economic evaluation populations indicated two lower than common thresholds paucity poor mean uncertainty high. Future work optimum design would multiarm randomised controlled trial, participants meeting inclusion criteria are receive colestipol, colesevelam placebo, all testing. Study registration This registered as PROSPERO CRD42020223877. Funding project funded National Institute Health Care Research (IHR) Evidence Synthesis programme will published full Technology Assessment ; Vol. 26, No. 45. See NIHR Journals Library website further information.