Evaluating treatment response thresholds for cost-effective treatment in metabolic dysfunction-associated steatotic liver disease

초록

Background/Aims: The first metabolic dysfunction-associated steatotic liver disease (MASLD) drug was approved with an unsatisfactorily small effect size. This study aimed to determine key factors impacting the cost-effectiveness of a new hypothetical MASLD drug as well as its treatment efficacy. Methods: A Markov model reflecting the natural history of MASLD was developed, incorporating fibrosis progression, cardiovascular disease risk, and mortality. Treatment effect of drug X (with $20,000ofannualcost)wasassumedtoachievea>=1stagefibrosisregression,witha25$68,010/QALY-below the $100,000/QALY willingness-to-pay threshold, indicating that drug X treatment is cost-effective. Two-way sensitivity analysis further highlighted that the drug should achieve at least a 15% initial regression gap and maintain a minimum 3% sustained durability gap to remain cost-effective. In addition baseline fibrosis stage distribution also acted as an influencing factor. Conclusions: Long-term sustained durability of the hypothetical drug, patient distribution based on baseline fibrosis stage, as well as initial treatment response rate are key factors that influence the cost-effectiveness of new MASLD drugs. (Clin Mol Hepatol 2026;32:276-288)

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