OBJECTIVES: Nonalcoholic Steatohepatitis (NASH) is associated with an accelerated progression toward cirrhotic NASH and advanced liver diseases. Resmetirom was conditionally approved in the United States (US), in conjunction with diet and exercise, for the treatment of adults with noncirrhotic NASH and moderate-to-advanced liver fibrosis. Objective of this study was to assess the cost-effectiveness of resmetirom compared with standard-of-care (SOC) NASH resolution and fibrosis improvement from the perspective of US private payers.

METHODS: A cost-effectiveness Markov model was developed to reflect the clinical pathways of patients with NASH and fibrosis stages F2 or F3. The model health states allow for noncirrhotic patients to achieve NASH resolution or NASH relapse in addition to the liver fibrosis disease states. Noncirrhotic states transition probabilities were estimated using the placebo arm from the MAESTRO-NASH phase 3 trial. Advanced liver disease transition probabilities were obtained from the literature. Resmetirom NASH and fibrosis treatment efficacy rates, adverse events rates, and noncirrhotic health utility were based on phase 3 clinical trial data. Costs and quality-adjusted life years (QALYs) were assessed over a lifetime horizon using a 3% annual discount rate. Deterministic and probabilistic sensitivity analysis (DSA and PSA) assessed model uncertainty.

RESULTS: Discounted lifetime costs and QALYs for resmetirom and SOC were, respectively; $799,397 vs. $586,333 and 11.86 vs. 9.97 QALYs. Assuming a willingness-to-pay (WTP) of $150K/QALY, resmetirom generated a net monetary benefit value of $69,531. When QALYs were valued at $150K, the DSA results and PSA results favored resmetirom. All the DSA scenarios generated a positive net monetary benefit (NMB). In the PSA, resmetirom was superior in 90.7% of the simulations. Resmetirom reduced lifetime decompensated cirrhosis, hepatocellular carcinoma, and liver transplants, respectively, by 44.4%, 44.8%, and 45.5% compared with SOC.

CONCLUSIONS: Resmetirom is a cost-effective treatment option compared to SOC in adult patients with noncirrhotic NASH and moderate-to-advanced liver fibrosis.