Patient-Reported Outcomes and the Economic Effects of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis: The Value Proposition

Hepatology

Volumn 68, Issue 6, 2018, Pages 2405-2412

  Younossi, Zobair M ^a  

^a Betty and Guy Beatty Center for Integrated Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE BURDEN; ECONOMIC EVALUATION; HEALTH CARE COST; HUMAN; NONALCOHOLIC FATTY LIVER; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT-REPORTED OUTCOME; PRIORITY JOURNAL; REVIEW; ECONOMICS;

HUMANS; NON-ALCOHOLIC FATTY LIVER DISEASE; PATIENT REPORTED OUTCOME MEASURES;

EID: 85054984602     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.30125     Document Type: Review

References (64)

1. Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, et al. The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Hepatology 2018;67:328-335.
2. Younossi Z, Henry L. Contribution of alcoholic and nonalcoholic fatty liver disease to the burden of liver-related morbidity and mortality. Gastroenterology 2016;150:1778-1785.
3. Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, et al. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol 2018;15:11-20.
4. Golabi P, Otgonsuren M, Cable R, Felix S, Koenig A, Sayiner M, et al. Non-alcoholic fatty liver disease (NAFLD) is associated with impairment of health related quality of life (HRQOL). Health Qual Life Outcomes 2016;14:18.
5. Younossi ZM, Henry L, Bush H, Mishra A. Clinical and economic burden of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clin Liver Dis 2018;22:1-10.
6. Younossi ZM, Henry L. Economic and quality-of-life implications of non-alcoholic fatty liver disease. Pharmacoeconomics 2015;33:1245-1253.
7. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease—meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology 2016;64:73-84.
8. Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology 2012;55:2005-2023.
9. Fazel Y, Koenig AB, Sayiner M, Goodman ZD, Younossi ZM. Epidemiology and natural history of non-alcoholic fatty liver disease. Metabolism 2016;65:1017-1025.
10. Anstee QM, Targher G, Day CP. Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat Rev Gastroenterol Hepatol 2013;10:330-344.
11. Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol 2013;10:686-690.
12. Kim GA, Lee HC, Choe J, Kim MJ, Lee MJ, Chang HS, et al. Association between non-alcoholic fatty liver disease and cancer incidence rate. J Hepatol 2018;68:140-146.
13. Lazo M, Hernaez R, Eberhardt MS, Bonekamp S, Kamel I, Guallar E, et al. Prevalence of nonalcoholic fatty liver disease in the United States: the third National Health and Nutrition Examination Survey, 1988–1994. Am J Epidemiol 2013;178:38-45.
14. Dulai PS, Singh S, Patel J, Soni M, Prokop LJ, Younossi Z, et al. Increased risk of mortality by fibrosis stage in nonalcoholic fatty liver disease: systematic review and meta-analysis. Hepatology 2017;65:1557-1565.
15. Younossi ZM, Stepanova M, Rafiq N, Makhlouf H, Younoszai Z, Agrawal R, et al. Pathologic criteria for nonalcoholic steatohepatitis: interprotocol agreement and ability to predict liver-related mortality. Hepatology 2011;53:1874-1882.
16. Angulo P, Kleiner DE, Dam-Larsen S, Adams LA, Bjornsson ES, Charatcharoenwitthaya P, et al. Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology 2015;149:389-397.
17. Dyson J, Jaques B, Chattopadyhay D, Lochan R, Graham J, Das D, et al. Hepatocellular cancer: the impact of obesity, type 2 diabetes and a multidisciplinary team. J Hepatol 2014;60:110-117.
18. Younossi ZM, Otgonsuren M, Henry L, Venkatesan C, Mishra A, Erario M, et al. Association of nonalcoholic fatty liver disease (NAFLD) with hepatocellular carcinoma (HCC) in the United States from 2004 to 2009. Hepatology 2015;62:1723-1730.
19. Younossi Z, Stepanova M, Ong JP, Jacobson IM, Bugianesi E, DusejaA, et al. Non-alcoholic steatohepatitis is the fastest growing cause of hepatocellular carcinoma in liver transplant candidates. Clin Gastroenterol Hepatol 2018. pii: S1542-3565(18)30611-6. https://doi.org/10.1016/j.cgh.2018.05.057. [Epub ahead of print].
20. Goldberg D, Ditah IC, Saeian K, Lalehzari M, Aronsohn A, Gorospe EC, et al. Changes in the prevalence of hepatitis C virus infection, nonalcoholic steatohepatitis, and alcoholic liver disease among patients with cirrhosis or liver failure on the waitlist for liver transplantation. Gastroenterology 2017;152:1090-1099.
21. Schwimmer JB, Deutsch R, Kahen T, Lavine JE, Stanley C, Behling C. Prevalence of fatty liver in children and adolescents. Pediatrics 2006;118:1388-1393.
22. Welsh JA, Karpen S, Vos MB. Increasing prevalence of nonalcoholic fatty liver disease among United States adolescents, 1988–1994 to 2007–2010. J Pediatr 2013;162:496-500.
23. Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 2018;67:123-133.
24. Younossi ZM, Loomba R, Rinella ME, Bugianesi E, Marchesini G, Neuschwander-Tetri BA Current and future therapeutic regimens for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Hepatology 2017; https://doi.org/10.1002/hep.29724. [Epub ahead of print].
25. Centers for Disease Control. Health-related quality of life. https://www.cdc.gov/HRQoL/concept.htm. Published May 2016. Accessed December 2017.
26. Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health 2012;15:437-442.
27. Younossi ZM. Chronic liver disease and health-related quality of life. Gastroenterology. 2001;120:305-307.
28. van der Plas SM, Hansen BE, de Boer JB, Stijnen T, Passchier J, de Man RA, et al. Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey. Quality of Life Res 2007;16:375-388.
29. Younossi ZM, Boparai N, Price LL, Kiwi ML, McCormick M, Guyatt G. Health-related quality of life in chronic liver disease: the impact of type and severity of disease. Am J Gastroenterol 2001;96:2199-2205.
30. Younossi ZM, Guyatt G, Kiwi M, Boparai N, King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut 1999;45:295-300.
31. Guyart G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40:171-178.
32. Sayiner M, Stepanova M, Pham H, Noor B, Walters M, Younossi ZM. Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease. BMJ Open Gastroenterol 2016;3:e000106.
33. Ware JE, Kosinski M. Interpreting SF-36 summary health measures: a response. Qual Life Res 2001;10:405-420.
34. Younossi ZM, Stepanova M, Henry L, Racila A, Lam B, Pham HT, et al. A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD. LiverInt 2017;37:1209-1218.
35. Younossi ZM, Stepanova M, Henry L. Performance and validation of Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV) in clinical trials of patients with chronic hepatitis C. Value Health 2016;19:544-551.
36. Younossi ZM, Afendy A, Stepanova M, Racila A, Nader F, Gomel R, et al. Development and validation of a primary sclerosing cholangitis–specific patient-reported outcomes instrument: the PSC PRO. Hepatology 2017; https://doi.org/10.1002/hep.29664. [Epub ahead of print].
37. Webster K, Odom L, Peterman A, Lent L, Cella D. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: validation of version 4 of the core questionnaire. Qual Life Res 1999;8:604.
38. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-365.
39. Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981;19:787-805.
40. EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
41. Dan AA, Kallman JB, Wheeler A, Younoszai Z, Collantes R, Bondini S, et al. Health-related quality of life in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther 2007;26:815-820.
42. Weinstein AA, Kallman Price J, Stepanova M, Poms LW, Fang Y, Moon J, et al. Depression in patients with nonalcoholic fatty liver disease and chronic viral hepatitis B and C. Psychosomatics 2011;52:127-132.
43. National Institute of Mental Health. Major depression. https://www.nimh.nih.gov/health/statistics/major-depression.shtml. Published November 2017. Accessed February 21, 2018.
44. Chawla KS, Talwalkar JA, Keach JC, Malinchoc M, Lindor KD, Jorgensen R. Reliability and validity of the Chronic Liver Disease Questionnaire (CLDQ) in adults with non-alcoholic steatohepatitis (NASH). BMJ Open Gastroenterol 2016;3:e000069.
45. Younossi ZM, Stepanova M, Lawitz E, Charlton M, Loomba R, Myers RP, et al. Improvement of hepatic fibrosis and patient-reported outcomes in non-alcoholic steatohepatitis treated with selonsertib. LiverInt 2018; https://doi.org/10.1111/liv.13706. [Epub ahead of print].
46. Xin S. Markov modelling in healthcare economic evaluations. Chinese Journal of Evidence-Based Medicine 2007;7:750-757.
47. Health Economics Associates. Health economic models. https://hea-consulting.com/services/health-economic-models. Accessed February 21, 2018.
48. Garber AM, Phelps CE. Economic foundations of cost-effectiveness analysis. J Health Econ 1997;16:1-31.
49. Marseille E, Larson B, Kazi DS, Kahn JG, Rosen S. Thresholds for the cost–effectiveness of interventions: alternative approaches. https://www.who.int/bulletin/volumes/93/2/14-138206/en/. Accessed July, 2018.
50. Wailoo AJ, Hernandez-Alava M, Manca A, Mejia A, Ray J, Crawford B, et al. Mapping to estimate health-state utility from non–preference-based outcome measures: an ISPOR Good Practices for Outcomes Research Task Force report. Value Health 2017;20:18-27.
51. Younossi ZM, Loomba R, Anstee QM, Rinella ME, Bugianesi E, Marchesini G, et al. Diagnostic modalities for non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and associated fibrosis. Hepatology 2017; https://doi.org/10.1002/hep.29721. [Epub ahead of print].
52. European Association for the Study of the Liver, European Association for the Study of Diabetes, European Association for the Study of Obesity. EASL-EASD-EASO clinical practice guidelines for the management of non-alcoholic fatty liver disease. J Hepatol 64:1388-1402.
53. Younossi ZM, Stepanova M, Rafiq N, Henry L, Loomba R, Makhlouf H, et al. Nonalcoholic steatofibrosis independently predicts mortality in nonalcoholic fatty liver disease. Hepatol Commun 2017;1:421-428.
54. Sayiner M, Otgonsuren M, Cable R, Younossi I, Afendy M, Golabi P, et al. Variables associated with inpatient and outpatient resource utilization among Medicare beneficiaries with nonalcoholic fatty liver disease with or without cirrhosis. J Clin Gastroenterol 2017;51:254-260.
55. NEJM Catalyst. What is value-based healthcare? https://catalyst.nejm.org/what-is-value-based-healthcare/. Published January 2017. Accessed February 5, 2018.
56. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371:796-797.
57. Younossi ZM, Blissett D, Blissett R, Henry L, Stepanova M, Younossi Y, et al. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology 2016;64:1577-1586.
58. Younossi ZM, Priyadarshini M, Tampi R, Nader F, Younossi IM, Racila A. Burden of illness economic model for patients with clinically relevant non-alcoholic steatohepatitis (NASH) in the United States [Abstract]. AASLD 2017.
59. Younossi ZM, Park H, Dieterich D, Saab S, Ahmed A, Gordon SC. The value of cure associated with treating treatment-naive chronic hepatitis C genotype 1: are the new all-oral regimens good value to society? LiverInt 2017;37:662-668.
60. Younossi ZM, Zheng L, Stepanova M, Henry L, Venkatesan C, Mishra A. Trends in outpatient resource utilizations and out-comes for Medicare beneficiaries with nonalcoholic fatty liver disease. J Clin Gastroenterol 2015;49:222-227.
61. Younossi ZM. What is the ethical responsibility of a provider when prescribing the new direct-acting antiviral agents to patients with hepatitis C infection? Clin Liver Dis (Hoboken) 2015;6:117-199.
62. Corey KE, Klebanoff MJ, Tramontano AC, Chung RT, Hur C. Screening for nonalcoholic steatohepatitis in individuals with type 2 diabetes: a cost-effectiveness analysis. Dig Dis Sci 2016;61:2108-2117.
63. Stepanova M, Rafiq N, Younossi ZM. Components of metabolic syndrome are independent predictors of mortality in patients with chronic liver disease: a population-based study. Gut 2010;59:1410-1415.
64. Allen AM, Van Houten HK, Sangaralingham LR, Talwalkar JA, McCoy RG. Healthcare cost and utilization in nonalcoholic fatty liver disease: real-world data from a large US claims database. Hepatology 2018; https://doi.org/10.1002/hep.30094. [Epub ahead of print].