Christopher V Almario1, Benjamin D Noah2, Alma Jusufagic3, Daniel Lew4, Brennan M R Spiegel5. 1. Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California; Division of Health Services Research, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California. 2. Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California. 3. Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California. 4. Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California. 5. Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California; Division of Health Services Research, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California. Electronic address: Brennan.Spiegel@cshs.org.
Abstract
BACKGROUND & AIMS: Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) relies on the Rome IV symptom-based criteria, which are imperfect for separating functional vs organic disease. Biomarker tests for IBS-D might be added to symptom data to allow clinicians to make more accurate and precise diagnoses in a cost-effective manner. We tested the economic consequences of using a range of hypothetical IBS-D biomarkers, and explored at what cost and level of accuracy a biomarker becomes cost effective. We produced a framework for payers to evaluate the return on an investment of implementing IBS-D biomarkers of varying accuracy and cost. METHODS: We used decision analysis software to evaluate a hypothetical cohort of patients who met Rome IV criteria for IBS-D. We conducted cost-utility and budget impact analyses of 2 competing approaches: usual care or an IBS biomarker-based diagnostic approach. Patients in the usual care group received empiric IBS treatment; non-responders received additional diagnostic tests for organic disease. In the group evaluated with a biomarker test, those with a positive result received IBS treatment before additional diagnostic analyses, whereas patients with a negative result underwent upfront diagnostic testing. Outcomes were incremental cost per quality-adjusted life year gained (third-party payer perspective) and incremental per-member per-month cost. RESULTS: In the base-case analysis, using a willingness-to-pay threshold of $100,000/quality-adjusted life year, we found that biomarkers are not cost effective when the biomarker test costs more than $846, even if the test is 100% accurate in detecting IBS-D. In probabilistic analysis using 1,000 simulations, most trials (75% or more) show that the biomarker-based diagnostic approach is cost effective above the following accuracy thresholds: a $100 biomarker test with 51% accuracy, a $200 test with 57% accuracy, a $300 test with 63% accuracy, a $400 test with 69% accuracy, a $500 test with 76% accuracy, a $600 test with 82% accuracy, a $700 test with 89% accuracy, and a $800 test with 94% accuracy. CONCLUSIONS: In decision analysis of a hypothetical cohort of patients who met Rome IV criteria for IBS-D, we identified cost and accuracy thresholds that can guide investigators and payers as they develop, validate, price, and/or reimburse IBS-D biomarker tests for use in everyday clinical practice.
BACKGROUND & AIMS: Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) relies on the Rome IV symptom-based criteria, which are imperfect for separating functional vs organic disease. Biomarker tests for IBS-D might be added to symptom data to allow clinicians to make more accurate and precise diagnoses in a cost-effective manner. We tested the economic consequences of using a range of hypothetical IBS-D biomarkers, and explored at what cost and level of accuracy a biomarker becomes cost effective. We produced a framework for payers to evaluate the return on an investment of implementing IBS-D biomarkers of varying accuracy and cost. METHODS: We used decision analysis software to evaluate a hypothetical cohort of patients who met Rome IV criteria for IBS-D. We conducted cost-utility and budget impact analyses of 2 competing approaches: usual care or an IBS biomarker-based diagnostic approach. Patients in the usual care group received empiric IBS treatment; non-responders received additional diagnostic tests for organic disease. In the group evaluated with a biomarker test, those with a positive result received IBS treatment before additional diagnostic analyses, whereas patients with a negative result underwent upfront diagnostic testing. Outcomes were incremental cost per quality-adjusted life year gained (third-party payer perspective) and incremental per-member per-month cost. RESULTS: In the base-case analysis, using a willingness-to-pay threshold of $100,000/quality-adjusted life year, we found that biomarkers are not cost effective when the biomarker test costs more than $846, even if the test is 100% accurate in detecting IBS-D. In probabilistic analysis using 1,000 simulations, most trials (75% or more) show that the biomarker-based diagnostic approach is cost effective above the following accuracy thresholds: a $100 biomarker test with 51% accuracy, a $200 test with 57% accuracy, a $300 test with 63% accuracy, a $400 test with 69% accuracy, a $500 test with 76% accuracy, a $600 test with 82% accuracy, a $700 test with 89% accuracy, and a $800 test with 94% accuracy. CONCLUSIONS: In decision analysis of a hypothetical cohort of patients who met Rome IV criteria for IBS-D, we identified cost and accuracy thresholds that can guide investigators and payers as they develop, validate, price, and/or reimburse IBS-D biomarker tests for use in everyday clinical practice.
Authors: Brennan M R Spiegel; Gareth S Dulai; Brian S Lim; Neel Mann; Fasiha Kanwal; Ian M Gralnek Journal: Clin Gastroenterol Hepatol Date: 2006-07-17 Impact factor: 11.382
Authors: Brennan M R Spiegel; Mary Farid; Eric Esrailian; Jennifer Talley; Lin Chang Journal: Am J Gastroenterol Date: 2010-03-02 Impact factor: 10.864
Authors: Michael D Kappelman; Sheryl L Rifas-Shiman; Carol Q Porter; Daniel A Ollendorf; Robert S Sandler; Joseph A Galanko; Jonathan A Finkelstein Journal: Gastroenterology Date: 2008-09-17 Impact factor: 22.682
Authors: Brennan Spiegel; Lucinda Harris; Susan Lucak; Emeran Mayer; Bruce Naliboff; Roger Bolus; Eric Esrailian; William D Chey; Anthony Lembo; Hetal Karsan; Kirsten Tillisch; Gareth Dulai; Jennifer Talley; Lin Chang Journal: Am J Gastroenterol Date: 2009-06-02 Impact factor: 10.864