Semaglutide deemed cost-effective for HFpEF with obesity in German healthcare, despite substantial budget impact

Heart failure with preserved ejection fraction (HFpEF) is a prevalent and debilitating condition with limited disease-modifying therapies. Patients with HFpEF often present with obesity, a comorbidity that exacerbates symptoms and worsens prognosis. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like semaglutide have demonstrated improvements in symptoms and weight in trials like STEP-HFpEF. However, the economic value and affordability of integrating semaglutide into healthcare systems for this specific patient population remained an important unanswered question.

Researchers developed a cohort state-transition (Markov) model, based on data from the STEP-HFpEF trial, to assess semaglutide versus placebo. The analysis adopted the perspective of the German statutory health insurance (SHI) system for patients with HFpEF and obesity. Health states were defined by quartiles of the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) and death. Primary outcomes included total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Various sensitivity analyses, including deterministic, probabilistic, and time-horizon scenarios, were performed. A 1-year prevalence-based budget impact analysis estimated additional SHI expenditure under different eligibility and uptake scenarios.

Over a 5-year horizon, semaglutide significantly increased total costs from 12,748.6 € to 17,690.5 € (in 2025 €). Concurrently, it increased QALYs from 3.208 to 3.371, resulting in an ICER of 30,443 €/QALY. This yielded a positive incremental net monetary benefit, indicating economic value. Over a shorter 1-year period, the ICER was higher at 82,237 €/QALY. At the base-case price, the probability of semaglutide being cost-effective at a 100,000 €/QALY threshold was 0.911, which improved with further price reductions. The 1-year budget impact was substantial, ranging from approximately 168 million € to 864 million €, depending on the eligibility criteria and patient uptake.

Semaglutide increased QALYs by 0.163 over 5 years while generating an ICER of 30,443 €/QALY, suggesting it is cost-effective under base-case assumptions.