보험인정기준 상세내용

■ 고시 신설 전체내용



식품의약품안전처장이 인정한 범위 내에서 투여 시 요양급여를 인정함.



※ 식품의약품안전처장이 인정한 범위:

4세 이상 당뇨 환자에서 발생한 심각한 저혈당증



■ 고시 신설 고시번호(시행일자)

고시 제2025-224호(2026.1.1.)



■ 고시 신설 사유

○긴급도입의약품인 ‘바크시미나잘스프레이’가 신규 등재 예정임에 따라 급여기준을 신설함



■ 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.

· Marga G, Kamlesh K et al. Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia. Diabetes Therapy (2023) 14:1757？1769

· Jeffrey G. et al. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Therapy (2020) 11:1591？1603

· 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.

· Jennifer L. et al. Glucagon Nasal Powder: A Promising Alter native to Intramuscular Glucagon in Youth With Type 1 Diabetes, Diabetes Care 2016;39:555？562