Abstract

Objectives

To assess the cost-effectiveness of resmetirom for the treatment of metabolic dysfunction-associated steatohepatitis in Brazil.

Methods

A Markov model was developed using TreeAge Pro® 2009 from the perspective of the Brazilian public healthcare system. The model used a 20-year time horizon with annual cycles. Seven health states were included: absence of fibrosis (F0), mild to advanced fibrosis (F1, F2, and F3), cirrhosis (F4), liver transplantation, and mortality. Costs were reported in Brazilian reais (BRL) and purchasing power parity US dollars (PPP-USD), and outcomes were measured in quality-adjusted life-years (QALYs). Both deterministic and probabilistic sensitivity analyses were performed. Incremental cost-effectiveness ratios (ICERs) were compared with multiple willingness-to-pay thresholds to determine cost-effectiveness.

Results

Resmetirom demonstrated an average incremental cost of 121 762 PPP-USD and an incremental gain of 1.05 QALYs compared with placebo. The mean ICER was approximately 40 017 PPP-USD/QALY, with a symmetric distribution and moderate variability (30 869-50 234 PPP-USD/QALY). The ICER scatterplot showed a predominance in the northeast quadrant, with no instances of dominance. The model was consistent across variations in input parameters.

Conclusions

Resmetirom was more effective than placebo but incurred higher costs. From the healthcare system perspective, it was not considered cost-effective under Brazil’s conventional willingness-to-pay thresholds (1 to 3 times gross domestic product per capita per QALY) or thresholds based on opportunity cost. These findings underscore the need for caution in coverage and reimbursement decisions.