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Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月2日

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  • Bent Estler,
  • Hanna Fröhlich,
  • Tobias Täger,
  • Norbert Frey,
  • Lutz Frankenstein

摘要

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.