Cost-Effectiveness of Sotagliflozin in Heart Failure Patients with Preserved and Reduced Ejection Fractions – Results from SOLOIST-WHF

BACKGROUND In the SOLOIST-WHF trial (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) evaluating patients with type 2 diabetes and recent worsening heart failure, initiation of sotagliflozin before or soon after hospital discharge reduced cardiovascular and heart failure-related clinical events, including hospitalizations and urgent visits. We assessed the long-term cost-effectiveness of sotagliflozin in the overall trial population and according to ejection fraction subtype, including heart failure with preserved ejection fraction (HFpEF ≥50%) and reduced ejection fraction (HFrEF <50%). METHODS A patient-level Markov microsimulation model incorporating treatment effects observed in SOLOIST-WHF, national cost estimates, and externally derived health-state utility values was used to project lifetime clinical and economic outcomes from a healthcare payer perspective. Net monthly treatment costs for sotagliflozin were estimated at $434. Lifetime projections included healthcare expenditures, cardiovascular and heart failure events, survival, and quality-adjusted life-years (QALYs) comparing sotagliflozin with placebo among patients eligible for SOLOIST-WHF. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per QALY gained, and uncertainty was evaluated through sensitivity analyses. RESULTS Across the lifetime horizon, sotagliflozin increased quality-adjusted survival by 0.39 QALYs (4.43 vs. 4.04) and life expectancy by 0.64 life-years (7.12 vs. 6.48) compared with placebo, with an incremental cost of $29,449 (95% uncertainty interval [UI]: $26,610-$32,528), corresponding to an ICER of $75,510 per QALY gained (UI: $55,640-$98,300). Among patients with HFpEF, treatment produced gains of 0.43 QALYs (4.53 vs. 4.10) and 0.68 life-years (7.14 vs. 6.46) at an incremental cost of $30,587 (UI: $28,459-$35,826), yielding an ICER of $71,135 per QALY (UI: $61,482-$87,652). In patients with HFrEF, sotagliflozin increased outcomes by 0.37 QALYs (4.33 vs. 3.96) and 0.63 life-years (7.09 vs. 6.46) with incremental costs of $32,425 (UI: $31,011-$38,127), resulting in an ICER of $87,635 per QALY (UI: $74,751-$112,287). Improvements in QALYs were primarily driven by reductions in cardiovascular events, and results were most sensitive to medication cost and readmission rates. CONCLUSIONS At an estimated monthly price of $434, sotagliflozin represents a clinically beneficial and economically favorable treatment for patients with diabetes and recent worsening heart failure across ejection fraction groups, with slightly greater cost-effectiveness observed among patients with HFpEF than HFrEF (ClinicalTrials.gov identifier: NCT03521934).