Author information
- Department of Medicine, Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
- Center for Liver Diseases and Masses, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
- Veritas Health Economics Consulting, Inc., Carlsbad, CA.
- Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, OH.
Abstract
Background: Nonalcoholic fatty liver disease (NAFLD) is associated with substantial morbidity, mortality, and economic burden. With currently no approved treatment, an effectual pharmaceutical intervention for this disease must be both clinically- and cost-effective.
Methods: A Markov model was constructed to estimate clinical outcomes, costs, and quality of life impact of a hypothetical pharmaceutical intervention. Lifetime clinical outcomes, life-years, quality-adjusted life-years (QALYs), costs (2020 $US), incremental cost-effectiveness ratios (ICERs), and economically justifiable prices (EJPs) were quantified. Only patients with fibrosis stage F2-F4 were assumed eligible to initiate pharmaceutical treatment.
Results: Over a mean life expectancy of approximately 21 years in the simulated cohort, drug treatment reduced liver-related mortality by 6.0% (2.7% absolute reduction). Assuming an annual drug cost of $36,000, total discounted medical costs were $574,238 and $120,312 for drug and usual care, respectively, with discounted QALYs estimated to be 9.452 and 9.272 for the two comparators. This yielded an ICER of $2,517,676/QALY gained. The EJP of drug at an ICER threshold of $150,000/QALY gained was $2,633, a 93% reduction from base case. Sensitivity analyses suggest that, without a substantial decrease in drug price, ICERs would exceed $500,000/QALY gained even with the most favorable efficacy assumptions.
Conclusions: For a pharmaceutical intervention to be considered cost effective in the NAFLD fibrosis population, substantial clinical benefit will need to be coupled with a modest annual price. Annual drug costs exceeding $12,000 likely will not provide reasonable value, even with favorable efficacy. More work is needed to estimate the cost-effectiveness of lifestyle modifications.