Cost-effectiveness and potential value of pharmaceutical treatment of nonalcoholic fatty liver disease. (31st December 2022)

• Record Type: Journal Article
• Authors: Rustgi, Vinod K.; Duff, Steve B.; Elsaid, Mohamed I.
• Is Part Of: Journal of medical economics. Volume 25:Number 1(2022)
• Page Start: 347
• Page End: 355
• Publication Date: 2022-12-31
• Subjects: NASH -- fibrosis -- cost burden -- cirrhosis -- natural history; C21 -- C2 -- C -- C22 -- C2; Medical care -- Cost control -- Periodicals; Medical economics -- Periodicals; 362.10941
• DOI: 10.1080/13696998.2022.2026702
• Languages: English
• ISSNs: 1369-6998

Abstract

Abstract: Background: Nonalcoholic fatty liver disease (NAFLD) is associated with substantial morbidity, mortality, and economic burden. With currently no approved treatment, an effective pharmaceutical intervention for this disease must be both clinically- and cost-effective. Methods: A Markov model was constructed to estimate the 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 the drug at an ICER threshold of $150, 000/QALY gained was $2, 633, a 93% reduction from a base case. Sensitivity analyses suggest that, without a substantial decrease in the 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, the 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.