보험인정기준 상세내용

■ 고시 개정 전체내용



허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

- 아 래 -

○ 좌심실 수축기능이 저하된 만성 심부전 환자(NYHA class Ⅱ∼Ⅳ)중, 좌심실 박출률(LVEF: Left Ventricular Ejection Fraction)이 40% 이하인 환자로서 표준치료(베타차단제, aldosterone antagonist 등)와 병용하여 투여함.



- 단, ACE 억제제 또는 Angiotensin Ⅱ 수용체 차단제와의 병용투여는 인정하지 아니함.



■ 고시 개정 고시번호(시행일자)

고시 제2023-120호(2023.7.1.)



■ 고시 개정 사유

○교과서, 가이드라인, 임상논문, 학회의견 등을 참조하여 좌심실 박출률(LVEF) 40% 이하에서 투여 조건을 변경함



■ 관련근거

1. Current Medical Diagnosis & Treatment 2023. Copyright ⓒ 2023 > 10-40: Heart Failure

2. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. Twelfth Edition. Copyright ⓒ 2022 > Chapter 50. Management of Heart Failure Patients with Reduced Ejection Fraction

3. Ferri's Clinical Advisor 2023 > Heart Failure

4. Fuster and Hurst's The Heart, 15e. Copyright ⓒ 2022 > Chapter 48: Diagnosis and Management of Chronic Heart Failure

5. Harrison's Principles of Internal Medicine 21e, > Chapter 258 : Heart Failure: Management

6. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure

7. 2022 심부전 진료지침, 대한심부전학회

8. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure, European Heart Journal (2021) 42, 3599-3726

9. CCS/CHFS Heart Failure Guidelines Update: Defining a New Pharmacologic Standard of Care for Heart Failure With Reduced Ejection Fraction, Canadian Journal of Cardiology 37 (2021) 531-546

10. Tsutsui H, et al. JCS/JHFS 2021 Guideline Focused Update on Diagnosis and Treatment of Acute and Chronic Heart Failure. J Card Fail 2021;27(12):1404-1444.

11. Solomon SD, et al. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med 2019;381(17):1609-1620.

12. Solomon SD, et al. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation 2020;141(5):352-361.

13. FDA_ CARDIOVASCULAR AND RENAL DRUGS Advisory Committee Briefing Document,15-Dec-2020 Entresto® (sacubitril/valsartan) for Chronic Heart Failure and Preserved Ejection Fraction

14. Januzzi JL, et al. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA 2019;322(11):1085-1095.

15. Houchen E, et al. Hospitalization Rates in Patients with Heart Failure and Reduced Ejection Fraction Initiating Sacubitril/Valsartan or Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers: A Retrospective Cohort Study. Cardiol Ther 2022;11(1):113-127.

16. Tan NY, et al. Comparative effectiveness of sacubitril-valsartan versus ACE/ARB therapy in heart failure with reduced ejection fraction. J Am Coll Cardiol Heart Fail 2020;8(1):43-54

17. Pathadka S, et al. Hospitalization and Mortality in Patients With Heart Failure Treated With Sacubitril/Valsartan vs. Enalapril: A Real-World, Population-Based Study. Front Cardiovasc Med 2021;7:602363.

18. CADTH (2021.3.)

19. INESS (2020.11)

20. HAS (2016. 5.)



■ 변경 전 고시번호(시행일자)

고시 제2022-56호(2022.3.1)