Abstract

Introduction: In May 2020, the US FDA approved the use of dapagliflozin, an SGLT2 inhibitor, for the reduction of cardiovascular death and heart failure hospitalization in patients with heart failure with reduced ejection fraction (HFrEF). We examined the cost-effectiveness of adding dapagliflozin to guideline-directed medical therapy (GDMT) in patients with or without diabetes. Methods: We developed a state-transition Markov model with inputs from the DAPA-HF trial, FDA review documents, published literature, and nationally representative datasets (Panel A). The model was calibrated to event rates observed in DAPA-HF; survival was extrapolated using non-parametric approaches. The main outcomes were quality-adjusted life years (QALYs) and incremental cost effectiveness ratio (ICER) of dapagliflozin + GDMT compared with GDMT alone, from a healthcare sector perspective and a lifetime analytic horizon. We applied a discount rate of 3% per year for future costs and benefits, and assumed a willingness-to-pay threshold of $100,000 per QALY gained. In sensitivity analyses, we examined subgroups with or without diabetes, and varied the cost of dapagliflozin (base case = $6,188 per year). This analysis was independent of the trial sponsor. Results: Compared with GDMT alone, adding dapagliflozin produced 0.57 additional QALYs at an incremental cost of $56,650, producing an ICER of $98,700 per QALY gained (Panel B). In subgroup analyses, dapagliflozin produced 0.71 additional QALYs in patients with diabetes at an ICER of $89,100 per QALY gained, and 0.48 additional QALYs in patients without diabetes at an ICER of $108,800 per QALY (Panels C and D). A 9% price reduction (to $5,613 per year) would make dapagliflozin cost-effective in patients without diabetes. Conclusions: Adding dapagliflozin to GDMT in patients with HFrEF is cost-effective and has the potential to improve long-term outcomes. Scalable strategies to improve access and uptake are urgently required.

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