Abstract

Background: SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) showed patients with diabetes and recent worsening heart failure (HF), sotagliflozin initiated before or shortly after discharge lowered incident cardiovascular deaths, hospitalizations, and HF urgent visits. In this study, we evaluated the cost-effectiveness of sotagliflozin in all patients and those with preserved (HFpEF ≥50%) and reduced (HFrEF <50%) ejection fraction. Methods: We ran a Markov microsimulation model based on treatment effects from SOLOIST-WHF, healthcare costs and utilities from national sources, and estimated net costs for sotagliflozin of $434 (range from $407 to $612) monthly, to calculate projected lifetime healthcare costs, HF and CVD events, survival, and quality-adjusted life-years (QALYs) for sotagliflozin vs placebo in SOLOIST-WHF eligible patients from a payer perspective. Outcome measured as the incremental cost-effectiveness ratio (ICER), incremental costs / QALYs gained. Sensitivity analyses assessed and quantified uncertainties. Results: Over a lifetime, sotagliflozin compared to placebo added 0.39 QALYs (4.43 vs. 4.04 QALYs) and 0.64 life-years (7.12 vs. 6.48) at an incremental cost of $29,449 (95% uncertainty interval (UI): $26,610-$32,528) for an ICER of $75,510 per QALY gained (UI: $55,640-$98,300). In HFpEF patients, sotagliflozin compared to placebo added 0.43 QALYs (4.53 vs. 4.10 QALYs) and 0.68 life-years (7.14 vs. 6.46) at an incremental cost of $26,615 (UI: $23,376-$29,694) for an ICER of $61,488 per QALY gained (UI: $41,618-$84,280). In HRrEF patients, sotagliflozin added 0.37 QALYs (4.33 vs. 3.96 QALYs) and 0.63 life-years (7.09 vs. 6.46) at an incremental cost of $30,012 (UI: $26,773-$33,251) for an ICER of $77,996 per QALY gained (UI: $58,126-$100,780). The benefit of sotagliflozin in QALY mainly results from the decrease in CVD deaths. Findings were sensitive to drug cost and number of readmissions. Conclusions: This study demonstrates that sotagliflozin priced from $407 to $612 per month is a clinically and economically favorable medication in patients with diabetes, recent worsening heart failure, with both preserved and reduced ejection fraction.

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