Cost-effectiveness analysis of dotinurad compared to febuxostat for gout with hyperuricemia in China: a modeling study

Dotinurad, a newly approved selective uric acid transporter 1 (URAT1) inhibitor, offers a novel treatment option for gout with hyperuricemia in China. However, its economic value relative to established urate-lowering therapies (ULTs) remains unclear. This study aimed to evaluate the cost‑effectiveness of dotinurad versus febuxostat for treating gout with hyperuricemia in China from the healthcare system perspective, and to supplement the primary comparison with a comparison against benzbromarone in a scenario analysis. A lifetime Markov model (1-month cycle) was developed for patients aged 53 years with chronic gout and serum uric acid (SUA) ≥ 7.0 mg/dL. Initial dosing followed the POS0255 trial (NCT05007392, first posted on ClinicalTrials.gov on 16 August 2021), with maintenance, dose escalation, and allopurinol as second-line therapy. Health states included controlled/uncontrolled SUA on first- or second-line treatment, or off treatment and death, along with a concomitant state of acute gout flare. Transition probabilities, costs, and utilities were derived from POS0255 trial, literature, and public databases. Outcomes included the incremental cost-effectiveness ratio (ICER) and incremental net monetary benefit (iNMB) at a willingness-to-pay (WTP) threshold of ¥99,665/QALY (1× GDP per capita). Sensitivity and scenario analyses were performed to assess the robustness of the model results and evaluate the impact of key assumptions under different input conditions. Dotinurad had higher total costs (¥92,222.27 vs. ¥89,214.76) and greater QALYs (9.93 vs. 9.90) than febuxostat, yielding an ICER of ¥123,487.37/QALY, which fell below the 3× GDP threshold (¥298,995) but exceeded the 1× GDP threshold (¥99,665). The iNMB was −¥580.19. Dotinurad was cost-effective in 16.2% of probabilistic simulations at the 1× GDP threshold and 52.0% at the 3× GDP threshold. From the Chinese healthcare-system perspective, dotinurad was not cost-effective versus febuxostat at the 1× GDP-per-capita WTP threshold but was cost-effective at the 3× GDP threshold. With sufficient budgetary capacity, dotinurad may broaden treatment options; NRDL inclusion should also consider budget impact, affordability, negotiated pricing, and unmet clinical needs. Not applicable.