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Research Article
27 September 2024

Evaluating the burden of illness of metabolic dysfunction–associated steatohepatitis in a large managed care population: The ETHEREAL Study

Publication: Journal of Managed Care & Specialty Pharmacy
Volume 30, Number 12

Abstract

BACKGROUND:

Metabolic dysfunction–associated steatohepatitis (MASH; formerly nonalcoholic steatohepatitis) is the inflammatory form of metabolic dysfunction–associated steatotic liver disease (formerly nonalcoholic fatty liver disease). MASH is a progressive disease associated with increased risk for many hepatic and extra-hepatic complications such as cirrhosis, hepatocellular carcinoma, the requirement for liver transplantation, and cardiovascular (CV)-related and kidney-related complications. It is important to understand the clinical and economic burden of MASH.

OBJECTIVES:

To assess and compare the clinical and economic burdens of MASH in adults with the non-MASH population in a real-world setting.

METHODS:

This observational, retrospective study used the Healthcare Integrated Research Database (HIRD), which contains health care claims data for commercially insured and Medicare Advantage health plan members across the United States. All-cause, CV-related, and liver-related medical costs and health care resource utilization were evaluated in patients with at least 2 diagnoses of MASH during the patient identification period (October 1, 2016, to April 30, 2022) and compared with a non-MASH cohort 1:1 matched on age, Quan Charlson Comorbidity Index, region of residence, and health plan type and length of enrollment. Generalized linear regression with negative binomial and γ distribution models were used to compare health care resource utilization and medical costs, respectively, while controlling for confounders. Covariate-adjusted all-cause, CV-related, and liver-related hospitalization rate ratios and medical cost ratios were assessed and compared for the MASH and matched non-MASH cohorts.

RESULTS:

A total of 18,549 patients with MASH were compared with 18,549 matched patients in the non-MASH cohort. After adjusting for covariates, MASH was associated with significantly higher rates of hospitalization and higher medical costs compared with the non-MASH cohort. When compared with the non-MASH cohort, patients with MASH had 1.22 (95% CI = 1.15-1.30; P < 0.0001) times higher rates of all-cause hospitalization, 1.13 (95% CI = 1.03-1.24; P = 0.008) times higher rates of CV-related hospitalization, and 7.22 (95% CI = 4.91-10.61; P < 0.0001) times higher rates of liver-related hospitalization. Similarly, all-cause medical costs were 1.26 (95% CI = 1.22-1.30; P < 0.0001) times higher, CV-related medical costs were 1.66 (95% CI = 1.59-1.73; P < 0.0001) times higher, and liver-related medical costs were 7.79 (95% CI = 7.42-8.17; P < 0.0001) times higher among patients with MASH.

CONCLUSIONS:

Compared with those of the non-MASH cohort with similar age, Quan Charlson Comorbidity Index, health plan, region of residence, and duration of enrollment, patients with MASH had significantly higher all-cause, CV-related, and liver-related hospitalizations and medical costs.

Plain language summary

This study used data from a health care claims database to assess the burden of a serious liver disease known as metabolic dysfunction–associated steatohepatitis (MASH). This study compared the use of health care services and costs between patients with and without MASH. Liver-related hospital stays and costs were more than 6 times higher in patients with MASH than those without MASH.

Implications for managed care pharmacy

Investigating health care resource utilization and costs associated with MASH will increase awareness of this progressive disease among providers, payers, and other decision-makers. This study demonstrated substantial clinical and economic burden of MASH compared with the non-MASH population emphasizing the importance of early recognition and intervention for better outcomes. Racial and ethnic differences in MASH-associated burden reported in this study reiterate the need for additional studies assessing health disparities in liver health.

Supplementary Material

Supplemental Material (24-106_supplement.pdf)
Supplemental Material

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Information & Authors

Information

Published In

cover image Journal of Managed Care & Specialty Pharmacy
Journal of Managed Care & Specialty Pharmacy
Volume 30Number 12December 2024
Pages: 1414 - 1430
PubMed: 39331041

History

Published online: 27 September 2024
Published in print: December 2024

Authors

Affiliations

Michael Charlton, MBBS* [email protected]
Department of Medicine, University of Chicago, Chicago, IL.
Ivy Tonnu-Mihara, PharmD, MS
Carelon Research, Wilmington, DE.
Chia-Chen Teng, MS
Carelon Research, Wilmington, DE.
Ziqi Zhou, MS
Carelon Research, Wilmington, DE.
Feven Asefaha, MS
Rakesh Luthra, MS
Health Economics and Outcomes Research, Novo Nordisk Inc., Plainsboro, NJ.
Amy Articolo, DO
Medical Affairs, Novo Nordisk Inc., Plainsboro, NJ.
Anthony Hoovler, MD
Medical Affairs, Novo Nordisk Inc., Plainsboro, NJ.
Chioma Uzoigwe, MPH
Real World Evidence, Novo Nordisk Inc., Plainsboro, NJ.

Notes

*
AUTHOR CORRESPONDENCE: Michael Charlton, 1.888.824.0200; [email protected]
Drs Tonnu-Mihara, Articolo, and Hoovler, Mr Luthra, Ms Uzoigwe are employees of Novo Nordisk Inc. Dr Tonnu-Mihara was not an employee of Novo Nordisk Inc. at the time of this study. Dr Charlton has consulted for Novo Nordisk, Pfizer, Madrigal, Sagimet, Ocelot, Novartis, Merck, Bristol Myers Squibb, 89Bio, and Intercept, and received research support from NorthSea, Pfizer, and Madrigal.

Funding Information

Ms Teng is an employee of Carelon Research Inc., a wholly owned subsidiary of Elevance Health Inc., and they received funding from Novo Nordisk to perform this research. Ms Asefaha is an employee of Panalgo and a contractor for Carelon Research Inc.

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