Cost-Effectiveness and Budget-Impact Analysis of Semaglutide in Heart Failure with Preserved Ejection Fraction and Obesity in the German Health-Care System.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is common, debilitating, and has limited availability of disease-modifying therapies. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as semaglutide improved symptoms and weight in the Semaglutide Treatment Effect in People with obesity and HFpEF (STEP-HFpEF) trial but their economic value in HFpEF is unclear. METHODS: We developed a cohort state-transition (Markov) model based on STEP-HFpEF to evaluate semaglutide versus placebo in patients with HFpEF and obesity from the German statutory health insurance (SHI) perspective. Health states were defined by Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) quartiles and death. Outcomes included costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Deterministic, probabilistic, time-horizon, and structural KCCQ trajectory scenario analyses were performed. A 1-year prevalence-based budget impact analysis estimated additional SHI expenditure under alternative eligibility and uptake scenarios. RESULTS: Over 5 years, semaglutide increased total costs (2025 €) (17,690.5 € versus 12,748.6 €) and QALYs (3.371 versus 3.208), yielding an ICER of 30,443 €/QALY and a positive incremental net monetary benefit. Over 1 year, the ICER was 82,237 €/QALY. At the base-case price, the probability that semaglutide is cost-effective at 100,000 €/QALY was 0.911, rising with further price reductions. The 1-year budget impact ranged from approximately 168 million € to 864 million €, depending on eligibility and uptake. CONCLUSIONS: Semaglutide appears cost-effective for HFpEF with obesity under the base-case assumptions and over longer analytic horizons. Yet it generates substantial budget impact, indicating that affordability and pricing will be critical for its sustainable implementation.