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Modeling the Disease Burden and Cost-Effectiveness of Screening and Treatment for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Patients

Award Number: R01HS026937
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Modeling the Disease Burden and Cost-Effectiveness of Screening and Treatment for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Patients - Project Summary/Abstract In the US, type 2 diabetes (T2D) is a major cause of morbidity and mortality due to microvascular and macrovascular complications. Nonalcoholic fatty liver disease (NAFLD) is another common co-morbidity but its burden in patients with T2D is poorly studied. Although NAFLD affects 50-70% of T2D patients, there is neither a screening guideline nor established treatment for NAFLD. Besides weight loss, pioglitazone – an old diabetes drug – is the only drug recommended by the American Association for the Study of Liver Diseases for treating NASH, the more progressive form of NAFLD, in patients with T2D. In addition, liraglutide (in phase 2 trials) and obeticholic acid (with phase 3 interim data) appear effective for improving NASH and advanced fibrosis. At least 4 other drugs (making a total of 5) are undergoing phase 3 trials and up to 50 drugs are in phase 2 trials. As new drugs become available in the near future, physicians and patients will face difficult tradeoffs among long-term benefits, risks, and costs. Given the widespread nature of NAFLD in patients with T2D, screening to identify those with NASH, who are at high-risk of advance liver disease, for early intervention may help patients live longer with a better quality life. Yet, the lack of comparative effectiveness and cost- effectiveness analyses of screening for NAFLD has resulted in conflicting clinical guidelines. Choosing the best treatment and screening strategy for NAFLD is complicated and can be aided by the use of computer-based models. Unfortunately, existing diabetes models do not include NAFLD, and NAFLD models do not account for diabetes and its complications. The objective of this study is to develop a computer simulation model of NAFLD in T2D to estimate its burden, and evaluate treatment and screening options for NASH. Specific aims are: 1) Develop and validate a microsimulation model of the natural history of NAFLD, including NASH; 2) Estimate and project the burden of NAFLD-associated liver complications in patients with T2D until 2030; 3) Assess the cost-effectiveness of treatments for NASH in patients with T2D; and 4) Evaluate the cost-effectiveness of screening for NASH in patients with T2D. This proposal builds upon our inter-disciplinary team’s strong foundation of constructing decision models to assist clinical decision making and studying the epidemiology of diabetes and NAFLD. Our model will provide a better understanding of a prevalent, important, yet underappreciated diabetes complication, using an innovative approach to diabetes and liver disease modeling. The study also establishes the groundwork for future evaluation of new treatment regimens and screening modalities for patients with T2D and NAFLD, which will advance the prevention and treatment of both diseases for millions of patients each year.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $367,899 )
2024	2024	THE CLEVELAND CLINIC FOUNDATION	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	8/13/2024	NON-COMPETING CONTINUATION	$367,899
														Subtotal = $367,899

Issue Date FY: 2023 ( Subtotal = $384,387 )
2023	2023	THE CLEVELAND CLINIC FOUNDATION	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	8/15/2023	NON-COMPETING CONTINUATION	$384,387
														Subtotal = $384,387

Issue Date FY: 2022 ( Subtotal = $389,221 )
2022	2022	CLEVELAND CLINIC FOUNDATION	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	9/2/2022	NON-COMPETING CONTINUATION	$389,221
														Subtotal = $389,221

Issue Date FY: 2021 ( Subtotal = $389,092 )
2021	2021	CLEVELAND CLINIC FOUNDATION, THE	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Research on Healthcare Costs, Quality and Outcomes	000	2	8/24/2021	NON-COMPETING CONTINUATION	$389,092
														Subtotal = $389,092

Issue Date FY: 2020 ( Subtotal = $398,552 )
2020	2020	CLEVELAND CLINIC FOUNDATION, THE	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	9/21/2020	NEW	$398,552
														Subtotal = $398,552

Grand Total All Awards = $1,929,151

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Modeling the Disease Burden and Cost-Effectiveness of Screening and Treatment for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Patients

Award Number: R01HS026937

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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