OBJECTIVES: In Japan, type 2 diabetes mellitus (T2DM) is a serious public health concern that places substantial clinical and economic burdens on healthcare systems. This research aims to perform a cost-effectiveness analysis (CEA) evaluating oral Semaglutide against the least expensive SGLT-2 inhibitor (luseogliflozin hydrate) in Japanese patients with T2DM.

METHODS: A cost-utility analysis was performed to evaluate the cost-effectiveness of 7mg QD oral semaglutide versus luseogliflozin 2.5mg, based on the Year 2021 pricing. Treatment effects were obtained from the aggregated randomized controlled trial data at Week 26 (+/- 2 weeks), using network meta-analysis. The CEA with the public healthcare payers’ perspective was conducted using the model built on the JJ Risk Engine risk prediction algorithm by pooling data from 1,748 Japanese patients with T2DM over 7.2 years (Tanaka et al., 2021). The base analysis timeframe was set for 30 years, considering the lifetime period of the disease. The treatment duration was assumed to be three years. Model inputs and assumptions were varied in deterministic sensitivity analyses and probabilistic sensitivity analyses to evaluate the impact on the outcomes.

RESULTS: In contrast with luseogliflozin 2.5 mg, treatments with oral Semaglutide 7mg were associated with improved effectiveness (+0.07 QALY) at a slightly higher annual total cost (+ ¥63,395) but reduced event costs for comorbidities, resulting in ICERs of ¥945,783 per QALY. Sensitivity analyses confirmed that these results were robust, and they remained below the cost-effectiveness threshold of ¥5,000,000/QALY, applied for HTA in Japan, ranging from ¥583,903 to ¥2,010,482 per QALY.

CONCLUSIONS: These findings suggest that oral Semaglutide are a cost-effective treatment option compared to the least expensive SGLT-2i, luseigliflozin hydrate, for patients with T2DM and its comorbidities, based on Japanese real-world evidence. This may inform decision-makers to allocate healthcare resources efficiently for life-long disease treatments.