Cost–utility analysis of sotagliflozin for heart failure patients with diabetes in China

Heart failure (HF) imposes a substantial economic burden, especially among populations with comorbidities in China. Sotagliflozin has shown clinical benefits in HF patients with type 2 diabetes mellitus (T2DM). This study evaluated the cost-utility of sotagliflozin in China and explored pricing strategies to support its potential market entry. A multistate Markov model was developed to assess the cost-utility of adding sotagliflozin to standard therapy in HF-T2DM patients, using data from the SOLOIST-WHF trial. A hypothetical cohort of 1000 patients was simulated, with transition probabilities adjusted for the Chinese population. Costs and utilities were derived from Chinese sources where available, and both outcomes and costs were discounted at 5% annually. Deterministic, probabilistic and scenario-based sensitivity analyses were conducted to assess uncertainty and evaluate alternative pricing scenarios. In the base-case analysis, the incremental cost-utility ratio of sotagliflozin was $50,072.77 per QALY, exceeding the Chinese willingness-to-pay threshold of $37,864. Deterministic analysis identified cardiovascular mortality in the control group as the most influential parameter. Probabilistic analysis showed a 38.84% probability of cost-utility. A 22.7% price reduction would be required for sotagliflozin to meet cost-effectiveness thresholds. Varying treatment duration did not change this outcome. This study found that sotagliflozin is not cost-effective for HF-T2DM patients in China at current prices. Its economic value is highly sensitive to drug cost, highlighting the need for localized pricing strategies. These findings can inform future reimbursement decisions and support value-based market entry planning.