OBJECTIVES: The SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial illustrated that in patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, significantly lowered cardiovascular deaths, hospitalizations, and urgent visits for heart failure. Based on these results, we determined lifetime health benefits, health care costs, and cost-effectiveness of sotagliflozin versus placebo in the US.

METHODS: We applied treatment effects from SOLOIST-WHF, health care costs and utilities from national sources, and estimated net costs for sotagliflozin of $434.34 (range from $407.39 to $611.84) monthly using a Markov simulation model to calculate projected lifetime healthcare costs, heart failure and CVD events, survival, and quality-adjusted life-years (QALYs) for sotagliflozin versus placebo in SOLOIST-WHF eligible patients from a payer perspective (with modifications to estimate a societal perspective). Uncertainty was quantified using stochastic, probabilistic sensitivity, and scenario analyses.

RESULTS: From the simulated cohort, average survival was 7.21 and 6.72 years, respectively. The lifetime QALYs for sotagliflozin and placebo were 4.59 and 4.26, respectively. The lifetime mean costs for sotagliflozin and placebo were $173,602 and $154,433, respectively. Sotagliflozin added 0.34 QALYs at an incremental lifetime cost of $19,169 (95% uncertainty interval (UI), $16,610,-$22,528), for an incremental cost effectiveness ratio of $57,090 per QALY gained (95%UI, $45,640-$98,300 per QALY gained. There were 29.2%, 93.8%, and 99.1% probabilities of being cost effective at willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per QALY gained, respectively. Findings were sensitive to drug cost and numbers of readmissions.

CONCLUSIONS: In this combined patient-level and simulation cost-effectiveness analysis in patients with diabetes and recent worsening heart failure, sotagliflozin priced at $434.34 a month, was projected to improve long-term clinical outcomes and be cost-effective at the American Heart Association suggested costing threshold of $100,000 per QALY gained.