Cost-effectiveness of early empagliflozin initiation after acute myocardial infarction: a German statutory health insurance perspective

Abstract Background and objective Empagliflozin reduced heart failure (HF) hospitalizations after acute myocardial infarction (MI) in EMPACT-MI without a mortality benefit. We assessed whether HF morbidity prevention generates long-term economic value from the German statutory health insurance perspective. Methods We developed a monthly cohort Markov model over a lifetime horizon comparing early empagliflozin plus standard care with standard care in post-MI patients at increased HF risk. The base case applied the EMPACT-MI hazard ratio of 0.77 for first HF hospitalization, assumed no direct mortality benefit, and modelled 24 months of treatment. Costs were in 2026 euros. The primary analysis covered 17.9 months; exploratory lifetime outcomes included quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results Early empagliflozin gained 0.0315 QALYs at €1,418 incremental cost (ICER €45,100/QALY) and avoided 52.0 lifetime HF hospitalizations per 1000 patients. The probability of cost-effectiveness was 16.2%, 55.2%, and 79.7% at €30,000, €50,000, and €80,000/QALY, respectively. Price reductions of 25% and 50% lowered the ICER to €32,300/QALY and €19,500/QALY. The maximum annual price compatible with €30,000/QALY was €607. Results were most sensitive to the HF hospitalization effect, drug price, and baseline HF risk. A trial-anchored analysis using the EMPACT-MI placebo event and mortality rates yielded a similar ICER (€47,200/QALY). Conclusions Early empagliflozin generated modest projected QALY gains, predominantly through modelled indirect survival gains, at higher lifetime costs.Economic value was conditional, depending on willingness-to-pay, net price, and absolute HF risk, with the most favorable profile at lower net prices and in HF-risk-enriched patients.