OBJECTIVES: Functional dyspepsia (FD) is a prevalent digestive disorder in China, characterized by postprandial discomfort and early satiety, which have a significant impact on quality-of-life and productivity. Prokinetic agents and traditional Chinese medicine (TCM) are widely used to treat FD in China with several drawbacks, like high adverse events and delayed action onset. This study aims to evaluate the cost-effectiveness of Aolanti, a novel herbal medicine (Aurantii Fructus extract), versus Zhizhu-Kuanzhong (ZZKZ) capsules for Chinese FD patients from the Chinese health system perspective.

METHODS: A decision tree and a 3-state Markov model were developed with a 1-year time horizon. Patients initially received Aolanti or ZZKZ for 4 weeks, followed by 4 weeks without treatment depending on response. After 8 weeks, patients entered the Markov model with different initial health states (Controlled FD, Relapsed FD, Uncontrolled FD) with a 4-week time cycle. Efficacy data were obtained from the pivotal phase III clinical trial and an ongoing real-world study. Healthcare resource utilization and cost data are collected from published literature, public database, and expert interviews. Utility data were derived from published literature. Costs were expressed in 2024 CNY (¥).

RESULTS: Aolanti extended asymptomatic survival by 30% (0.47 years vs 0.36 years) compared to ZZKZ, with an additional ¥2454.66 in total cost and a quality-adjusted life years (QALY) gains of 0.0232 over 1 year. The base case incremental cost-effectiveness ratio (ICER) was ¥10,943 per QALY gained, considered cost-effective at a willingness-to-pay of ¥107,230/QALY (1.2 times of GDP-per-capita in China).

CONCLUSIONS: Overall, Aolanti is likely to be a cost-effective option compared with ZZKZ capsules for Chinese FD patients. Meanwhile, it might also be meaningful to include a social perspective assessment since FD is a non-fatal disease, and recurrent symptoms could reduce productivity. Study results will be updated as ongoing real-world data become available.