Screening for Metabolic Dysfunction-Associated Steatohepatitis in Adults with Type 2 Diabetes in the U.S. and 5 European Countries: A Cost-Utility Analysis.

Abstract

Background & aims: Despite growing consensus of guidelines supporting screening for MASLD using non-invasive tests (NITs) in high-risk populations, access to NITs remains limited across the U.S. and E.U. Cost-effectiveness analyses of multimodal NIT strategies are needed to support implementation, address access challenges and inform coverage decisions.

Methods: A decision-analytic Markov model was developed to evaluate the cost-effectiveness of five multimodal NIT strategies for MASLD in hypothetical cohorts of patients with type 2 diabetes across six U.S. and European markets, compared with no screening; univariate and probabilistic sensitivity analyses were conducted to assess uncertainty.

Results: Multi-step non-invasive screening strategies were cost-effective compared with no screening across all countries, with ICERs ranging from dominance to £18,572 per QALY gained. In Germany, France, Italy and the US, at least one strategy dominated no screening. Probabilistic sensitivity analysis demonstrated robust cost-effectiveness, with multi-step non-invasive strategies demonstrating a 90-100% probability of cost-effectiveness across countries. Screening strategies involving liver biopsy were dominated by no screening in all settings.

Conclusion: Multi-step non-invasive screening strategies represent a cost-effective approach to improving adherence to guideline-based MASLD care in high-risk populations. As therapeutics capable of reversing fibrosis stages enter the market, the value of screening may increase further. Future research should focus on evaluating the economic impacts of longer-term care and emerging MASH therapeutics.

Impact and implications: This paper uses a Markov model to evaluate five strategies for the screening and treatment of MASH in a hypothetical cohort of patients with T2DM in the UK, France, Germany, Spain, Italy, and the US. Despite professional guidelines recommending the use of non-invasive tests to screen and inform care delivery for patients high-risk for advanced fibrosis due to MASH, adoption and payer coverage of non-invasive tests remain limited in many markets. Clinicians, payers, and policymakers may consider the findings presented within this paper, which validate the cost-utility of guidelines-recommended non-invasive screening approaches in high-risk populations, when developing institutional protocols or coverage policies. As approved therapeutics (e.g., resmetirom, semaglutide) enter the market, the value proposition for cost-effective screening strategies will likely continue to grow.