OBJECTIVES

Despite guideline-directed disease-modifying therapies, patients suffering from heart failure with reduced ejection fraction (HFrEF) continue to face long-term clinical sequelae. Empagliflozin, a sodium glucose co-transporter 2 inhibitor (SGLT2i), has been shown to reduce hospitalizations and deaths in patients with HFrEF. We conducted a cost-utility analysis to estimate the value of add-on empagliflozin versus usual care (UC) for HFrEF from a UK healthcare system perspective.

METHODS

A three-state Markov model (stable HFrEF, hospitalization, death) was developed with a monthly cycle length and a 20-year time horizon. Stable HFrEF patients were stratified into New York Heart Association (NYHA) classes. Costs and quality-adjusted life-years (QALYs) were discounted at 3.5% annually. Event rates were extrapolated from published Kaplan-Meier curves, while utilities, NYHA class transition probabilities and costs were derived from literature and national reference sources when appropriate. Adverse event (AE) probabilities were converted from published rates. We performed deterministic and probabilistic sensitivity analyses to account for parameter uncertainty, and value of information (VOI) analysis for decision uncertainty.

RESULTS

Empagliflozin use resulted in an incremental cost and QALY of £2,483 and 0.09 over UC respectively with an incremental cost-effectiveness ratio (ICER) of £26,543/QALY. Baseline utility, cost of empagliflozin, and probability of AEs were significant drivers for the base-case ICER. Probabilistic sensitivity analysis using Monte Carlos simulation revealed a cost-effectiveness probability of 54.6% at a threshold of £30,000/QALY. Probability of empagliflozin being cost-effective plateaued at 65% with increasing willingness-to-pay (WTP) thresholds, reflecting high decision uncertainty that is largely driven by uncertainties in utility values, probabilities of AEs and costs of AEs.

CONCLUSIONS

Add-on empagliflozin is cost-effective versus UC in HFrEF management at a WTP threshold of £30,000/QALY but with high decision uncertainty. Further research is warranted to address underlying parameter uncertainty before empagliflozin can be recommended, with certainty, as a cost-effective treatment against UC.