De Novo Cost-Effectiveness Model Framework for Nonalcoholic Steatohepatitis-Modeling Approach and Validation

Area of Science:

• Hepatology
• Health Economics
• Pharmacoeconomics

Background:

• Nonalcoholic steatohepatitis (NASH) is a chronic liver disease with significant hepatic and extra-hepatic morbidity.
• Existing cost-effectiveness models (CEMs) for NASH often omit crucial comorbid conditions.
• This heterogeneity limits accurate assessment of NASH interventions.

Purpose of the Study:

• To develop a novel, de novo cost-effectiveness model (CEM) framework for NASH.
• To incorporate extra-hepatic disease states and outcomes alongside hepatic components.
• To enable future estimation of the cost-effectiveness of NASH interventions.

Main Methods:

• A hybrid patient-level simulation and cohort-level Markov model framework was developed.
• Model inputs included fibrosis progression, liver disease outcomes, comorbidity outcomes (cardiovascular disease, type 2 diabetes, obesity), mortality, quality of life, and costs.
• Efficacy and adverse event data were sourced from the REGENERATE trial interim analysis.

Main Results:

• The prototype analysis showed obeticholic acid increased total costs, life years, and quality-adjusted life years compared to standard of care.
• Cross-validation with existing models revealed significant differences, primarily due to mortality inputs and comorbidity effects.
• The model highlights the impact of comorbidities on NASH cost-effectiveness.

Conclusions:

• This is the first NASH CEM to integrate the clinical consequences of multiple comorbidities.
• The flexible framework allows for cost-effectiveness estimations in diverse settings.
• Further development is planned as more data become available.