Abstract
Introduction: Changes in composition of microbiome species may be associated with inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). IBD, which includes ulcerative colitis (UC) and Crohn's disease (CD) is an immune-mediated inflammatory disease whereas IBS is a chronic functional disease characterized by symptoms such as cramping, diarrhea, and constipation. Medications are used for IBD to treat the underlying disease and keep it in remission. IBS is more commonly addressed by symptom treatment and lifestyle adjustments. Thus, distinguishing between these two conditions is important. To address this need, uBiome® has developed SmartGutTM, a sequencing-based clinical microbial test that can detect beneficial and pathogenic microorganisms associated with IBS and IBD. In this study we developed a model to estimate the cost impact of using SmartGutTM in a US population of patients with gastrointestinal distress. Methods: A model was developed from a US payer perspective that provides SmartGutTM as a screening tool. The model estimates the incidence of gastrointestinal distress from the combined incidence rates of IBD, IBS, and other causes. Utilization was informed by manufacturer patient analysis. The cost of SmartGutTM was based on test costs from the manufacturer. Results: For a US payer covering 1,000,000 lives, the annual incidence of patients with chronic gastrointestinal distress is estimated to be 215,820, of which 27% are expected to receive repeat testing [uEB1] with an average of 2.35 screenings /patient. This costs the plan $151,527,972 annually, equating to an additional $12.63 per member per month compared to usual care. However, the SmartGutTM test report details the presence of microorganisms associated with IBS and IBD. The report includes recommendations for healthcare providers on treatment, lifestyle, and diet that can be discussed with the patient. Testing in these patients may lead to earlier identification of IBS or IBD, which may result in improved downstream outcomes and more efficient use of healthcare resources. Further research is being conducted in order to clearly delineate the test specifications of IBS and IBD and downstream health outcomes. Conclusion: Here we present our initial investigations to estimate the cost avoidance benefits of the early identification of and differentiation between IBD and IBS using SmartGutTM in a US population of patients, highlighting test costs and improved outcomes.
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