1. 허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. 췌염의 급성증상(급성췌염, 만성췌염의 급성악화기, 수술 후의 급성췌염, 췌관조영술 후 급성췌염, 외상성 췌염)의 개선 목적으로 급성기에 사용시 인정(허가사항에 따라 ‘주사용후탄 등’만 해당)
나. 파종혈관내응고증(DIC)에 급성기 사용시 인정
다. 혈액투석(Hemodialysis, 자702) 또는 혈액관류(Hemoperfusion, 자704)를 행하는 “출혈성 병변이 있는 환자이거나, 수술 전후의 환자, 혈소판수 50,000/mm3 미만의 저혈소판증 환자”에게 사용시 인정
라. 지속적정정맥 또는 동정맥혈액투석(Continuous venovenous or Arteriovenous hemodialysis, 자703) 또는 지속적 정정맥 또는 동정맥 혈액여과술(Continuous venovenous or Arteriovenous hemofiltration, 자705)에 사용시 인정
2. 허가사항 범위를 초과하여 아래와 같은 경우에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
○ 부분체외순환(ECMO)의 관류혈액 응고방지
■ 고시 개정 고시번호(시행일자)
고시 제2019-191호(2019.9.1.)
■ 고시 개정 사유
？ 허가사항, 교과서, 임상진료지침, 임상연구문헌, 관련학회 의견 등을 참조하여
췌관조영술 후의 급성췌염, 외상성 췌염, 혈액투석 또는 혈액관류를 시행하는 혈소판수 50,000/㎣ 미만의 저혈소판증 환자에 급여 인정함.
？ 임상연구문헌 및 전문가 의견 등에 따라 동 약제 허가사항을 초과하여 부분체외순환(ECMO)의 항응고방지 목적으로 사용 시 전액본인부담으로 인정함.
■ 관련문헌 등
· Current Medical Diagnosis & Treatment, 2019
· ERCP, 3e, 2019
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· ASGE(American Society For Gastrointestinal Endoscopy), Adverse events associated with ERCP(2017)
· 총담관결석의 진료 가이드라인, 대한췌담도학회(2013)
· American College of Gastroenterology Guideline: Management of Acute Pancreatitis. Am J Gastroenterol 2013;108(9):1400-15.
· Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015, Japanese Society of Hepato-Biliary-Pancreatic Surgery. J Hepatobiliary Pancreat Sci;2015;22:405-432
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· Tadashi Takeuchi et al. Clinical Evaluation of FUT-175(Nafamostat mesilate) on Pancreatitis, A Double-Blind Controlled Study with Gabexate Mesilate. Digestive Medicine 1984;1:269
· Ge Yu et al. Nafamostat Mesilate for Prevention of Post-ERCP Pancreatitis. Pancreas 2015;44:561？569.
· Kubiliun et al. Evaluation of Pharmacologic Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Systematic Review. Clinical Gastroenterology and Hepatology 2015;13:1231？1239
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· Critical Care Nephrology, 3e. 2019
· Brenner and Rector's The Kidney, 10e. 2016
· Textbook of Critical Care, 7e. 2017
· Handbook of Dialysis Therapy, 5e. 2017
· The Japanese Clinical Practice Guideline for acute kidney injury 2016, Journal of Intensive Care 2018;6:48
· Japanese Society for Dialysis Therapy Guidelines for Management of Cardiovascular Diseases in Patients on Chronic Hemodialysis. 2012. Therapeutic Apheresis and Dialysis 2012;16(5):387？435
· KDIGO Clinical Practice Guideline for Acute Kidney Injury, 2012.
· Eun Yi Kim et al. Low-Dose Nafamostat Mesilate in Hemodialysis Patients at High Bleeding Risk. The Korean Journal of Nephrology 2011;30:61-66
· T. Akizawa et al. Clinical Benefits of Nafamostat Mesilate as an Anticoagulant for High bleeding Risk Hemodialysis. Artificial Organs 1991;14:209-212
· Hyun Chul Kim et al. A Multi-Center Phase Ⅲ Clinical Trial to Assess the Influence to Bleeding and Anticoagulant Effect of Nafamostat Mesilate(Futhan) in Hemodialysis Patients with High Bleeding-Risk. The Korean Journal of Nephrology 2004;23(6):920-926.
· Yang et al. Superior Outcome of Nafamostat Mesilate as an Anticoagulant in Patients Undergoing Maintenance Hemodialysis with Intracerebral Hemorrhage. Renal Failure 2009;31:668-675
· T. Akizawa et al. Nafamostat Mesilate: A Regional Anticoagulant for Hemodialysis in Patients at High Risk for Bleeding. Nephron 1993;64:376-381
· Matsuo et al. Anticoagulation with Nafamostat Mesilate, a Synthetic Protease Inhibitor, in Hemodialysis Patients with a Bleeding Risk. Haemostasis 1993;23:135-141.
· Critical Heart Disease in Infants and Children. 3e.
· Oh’s Intensive Care Manual. 8e.
· Extracorporeal Life Support Organization(ELSO): General Guidelines for all ECLS Cases. August, 2017.
· Lim JY, et al. Anticoagultaion During Extracorporeal Membrane Oxygenation; Nafamostat Mesilate Versus Heparin. Ann Thorac Surg.2016 Aug;102(2):534-9.
· Park JH, et al. Nafamostat mesilate as a regional anticoagulant in patients with bleeding complications during extracorporeal membrane oxygenation. Int J Artif Organs 2015; 38(11): 595 ？ 9.
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