식품의약품안전처장이 인정한 범위 내에서 ‘당뇨병을 가진 소아·성인의 중증 저혈당증’에 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
※ 식품의약품안전처장이 인정한 범위
1. 치료목적 사용
당뇨병을 가진 소아·성인의 중증 저혈당증 치료
2. 진단목적 사용
성인의 위장관 운동 억제(검사 진단보조)
■ 고시 신설 고시번호(시행일자)
고시 제2025-224호(2026.1.1.)
■ 고시 신설 사유
○긴급도입의약품인 ‘글루카겐하이포키트주’가 등재예정임에 따라 급여기준을 신설함. 다만, 식품의약품안전처장이 인정한 범위 내에서 ’치료목적으로 당뇨병을 가진 소아·성인의 중증 저혈당증’으로 제한함
■ 관련문헌 등
· Goldman-Cecil Medicine 27e. 2024
· Harrison’s Principles of Internal Medicine, 21e. 2022.
· ADA(American Diabetes Association), 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes―2025.
· AACE(American Association of Clinical Endocrinology), Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan―2022 Update.
· 대한당뇨병학회, 당뇨병 진료지침 제8판. 2023.
· ISPAD Clinical Practice Consensus Guidelines 2022: Assessment and management of hypoglycemia in children and adolescents with diabetes.
· Andrew collier et al. comparison of Intravenous Glucagon and Dextrose in Treatment of Severe Hypoglycemia in an Accident and Emergency Department. Diabetes Care 10:712-15, 1987.
· MA. W. PATRICK et al. Comparison of intramuscular glucagon and intravenous dextrose in the treatment of hypoglycaemic coma in an accident and emergency department. Archives of Emergency Medicine, 1990, 7, 73-77.
· Michael R. Rickels et al. Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study. Diabetes Care 2016;39:264？270.
· Thomas R. Pieber et al. Dasiglucagon―A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. Diabetes Care 2021;44:1361？1367.
· Tadej Battelino et al. Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial. Pediatr Diabetes. 2021;22:734？741.
· Pharmacotherapy: A Pathophysiologic Approach, 11e. 2020
· ESGAR/ESPR(Europian Society of Gastrointestinal Abdominal Radiology/Europian Society of Paediatric Radiology), The first joint ESGAR/ESPR consensus statement on the technical performance of cross-sectional small bowel and colonic imaging(2016)
· ACR/SAR(American College of Radiology/Society of Abdominal Radiology), ACR？SAR？SPR PRACTICE PARAMETER FOR THE PERFORMANCE OF COMPUTED TOMOGRAPHY (CT) ENTEROGRAPHY (2015)
· Abhilash Perisetti et al. Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP), Endosc Int Open 2022; 10: E558？E561
· Anupam Aditi et al. Glucagon Shortens Cecal Intubation Time and Total Procedure Time During Colonoscopy: A Prospective, Double-Blind Placebo Controlled Randomized Trial, Biomed J Sci & Tech Res 22(2)-2019; 16467-16472