Abstract
BACKGROUND: The association between diabetes mellitus (DM) and metabolic dysfunction-associated steatotic liver disease (MASLD) is well documented, with DM increasing the risk of developing MASLD and liver fibrosis. AIM: To evaluate the cost-effectiveness and budget impact of transient elastography (TE) for detecting significant fibrosis in Thai patients with DM. METHODS: We conducted a lifetime cost-utility analysis from a societal perspective, combining a decision tree with a Markov model. Four alternatives were compared: Fibrosis-4 (FIB-4) index triage followed by TE, steatosis-associated fibrosis estimator (SAFE) score triage followed by TE, standalone TE, and no screening. Clinical probabilities, utilities, and costs came from previous studies and Siriraj Hospital data. Costs and quality-adjusted life-years (QALYs) were discounted 3% annually, and incremental cost-effectiveness ratios (ICERs) were judged against the 160000-Thai baht (THB; 4619 United States dollars [USD])/QALY threshold. A 5-year budget impact was evaluated from the payer perspective. RESULTS: Among the screening methods evaluated, TE alone yielded the highest total lifetime costs of 200403 THB (5785 USD) and the highest QALYs of 12.81. Compared to no screening, all strategies demonstrated cost-effectiveness with ICERs of 75961, 80385, and 98965 THB (2193, 2321, and 2857 USD)/QALY gained for FIB-4 + TE, SAFE + TE, and TE alone, respectively. Extended dominance favored SAFE + TE, yet probabilistic analysis showed FIB-4 + TE had the highest cost-effectiveness probability and the smallest budget impact. Estimated annual budget impacts amounted to 470.7-755.8 million THB (13.6-21.8 million USD). CONCLUSION: Implementing screening for significant fibrosis in patients with DM is cost-effective. In resource-limited settings, prioritizing the FIB-4 index as a triage tool before TE is recommended.