Cost‐Effectiveness of Pharmacologic Therapies for Metabolic Dysfunction–Associated Steatohepatitis With Significant Fibrosis in the United States
Ali A. Abdeen, Turgay Ayer, Aanan Biswas, Chase J. Wehrle, Sobia N. Laique, Ali AminianABSTRACT
Aims
The approval of new pharmacotherapies for metabolic dysfunction‐associated steatohepatitis (MASH) presents a critical need for value assessment. We evaluated the cost‐effectiveness of resmetirom, semaglutide and tirzepatide for U.S. adults with MASH and F2–F3 fibrosis.
Materials and Methods
We developed a Markov cohort model with a lifetime horizon from the perspective of a U.S. healthcare payer. The model simulated biopsy‐confirmed patients with MASH progressing through liver‐specific health states. Efficacy inputs for fibrosis regression and MASH resolution were obtained from a Bayesian network meta‐analysis. Each pharmacotherapy was compared individually against standard of care; a formal sequential incremental analysis across active therapies was not performed. Cost‐effectiveness was assessed against the standard of care using a $100 000/QALY willingness‐to‐pay threshold.
Results
In the base‐case analysis, tirzepatide had the largest QALY gain and the lowest incremental cost relative to standard of care, yielding an incremental cost‐effectiveness ratio of ($42 705/QALY). Semaglutide was also cost‐effective (ICER: $80 076/QALY). Resmetirom (ICER: $273 445/QALY) exceeded the WTP threshold. Drug price was the most influential parameter in sensitivity analyses; probabilistic sensitivity analysis showed a 99.5% probability of cost‐effectiveness for tirzepatide and 89.8% for semaglutide at $100 000/QALY.
Conclusions
At current U.S. prices, tirzepatide and semaglutide are cost‐effective for MASH with F2–F3 fibrosis, while resmetirom is not. The tirzepatide finding should be interpreted with caution, given that it is not yet FDA‐approved for MASH and its effect estimate is based on a network meta‐analysis of a phase 2 trial. Payer coverage and equitable access to MASH therapies require value‐based pricing strategies.