Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea

Eui Soon Kim, Sun Kyeong Park, Jong Chan Youn, Hye Sun Lee, Hae Young Lee, Hyun Jai Cho, Jin Oh Choi, Eun Seok Jeon, Sang Eun Lee, Min Seok Kim, Jae Joong Kim, Kyung Kuk Hwang, Myeong Chan Cho, Shung Chul Chae, Seok Min Kang, Jin Joo Park, Dong Ju Choi, Byung Su Yoo, Jae Yeong Cho, Kye Hun KimByung Hee Oh, Barry Greenberg, Sang Hong Baek

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry. Methods: A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY). Results: Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY). Conclusion: There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.

Original languageEnglish
Article numbere8
JournalJournal of Korean Medical Science
Volume39
Issue number1
DOIs
StatePublished - 2024

Bibliographical note

Publisher Copyright:
© 2024 The Korean Academy of Medical Sciences.

Keywords

  • Cost-Effectiveness Analysis
  • Drug Therapy
  • Empagliflozin
  • Heart Failure
  • SGLT2 Inhibitors

Fingerprint

Dive into the research topics of 'Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea'. Together they form a unique fingerprint.

Cite this