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[일반원칙]

구 분	현 행	개 정(안)	사유
당뇨병용제	인슐린 비의존성 당뇨병(제2형 당뇨병) 환자에게 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 허가사항 범위이지만 동 인정기준 이외에는 약값 전액을 환자가 부담함. - 아 래 - 가. ~ 나. 생략 다. Exenatide 주사제 투여 1) 투여대상 생략 2) 투여방법 3종 병용요법(Metformin+ Sulfonylurea+Exenatide)을 인정 라. ~ 바. 생략 ※ 대상약제 [경구제 중 단일제] 생략 [경구제 중 복합제] 생략 [주사제] ⋅ Insulin 주사제 ⋅ Exenatide 주사제	인슐린 비의존성 당뇨병(제2형 당뇨병) 환자에게 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 허가사항 범위이지만 동 인정기준 이외에는 약값 전액을 환자가 부담함. - 아 래 - 가. ~ 나. 현행과 같음 다. GLP-1 수용체 효능제 1) 투여대상 현행과 같음 2) 투여방법 3종 병용요법(Metformin+ Sulfonylurea+GLP-1 수용체 효능제)을 인정 라. ~ 바. 현행과 같음 ※ 대상약제 [경구제 중 단일제] 현행과 같음 [경구제 중 복합제] 현행과 같음 [주사제] ⋅ Insulin 주사제 ⋅ GLP-1 수용체 효능제: Exenatide, Lixisenatide	‘약제급여목록 및 급여상한금액표’에 신규등재되는 릭수미아펜주의 국내·외 허가사항, 교과서, 관련 학회의견, 임상진료지침, 임상논문 및 외국급여평가자료 등을 참조하여 동일기전인 Exenatide와 동일하게 급여 인정함.

※ 관련근거

․ Harrison's online (Harrison's Principles of Internal Medicine 18e, 2012), Chapter 344. Diabetes Mellitus

․ Goldman's Cecil Medicine. 24th edition.(2012), Chapter 237 - Type 2 Diabetes Mellitus

․ Goodman & Gilman's The Pharmacological Basis of Therapeutics 12e.(Retrieved November 6 2013.)

․ Conn's Current Therapy 2014. Section 11. Endocrine and Metabolic disorders.

․ 대한당뇨병학회: 당뇨병 진료지침 2013.

․ NICE clinical guideline 87 (Issued: May 2009, last modified: March 2014) Type 2 diabetes: The management of type 2 diabetes

․ AACE Comprehensive Diabetes Management Algorithm ENDOCRINE PRACTICE Vol 19 No. 2 March/April 2013

․ Management of hyperglycemia in type 2 diabetes: A patient-centered approach - Position statement of the American Diabetes Association and the  European Association for the Study of Diabetes (ADA/EASD)

․ Scottish Intercollegiate Guidelines Network 116, March 2010 .Management of diabetes

․ Rosenstock J. et al. Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X) Diabetes Care. 2013 Oct;36(10):2945-51

․ Fonseca VA. et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012 Jun;35(6):1225-31

․ Ahrén B. et al. Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M). Diabetes Care. 2013 Sep;36(9):2543-50.

․ Yu Pan C. et al. Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: A randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Diabetes Metab Res Rev. 2014 Mar 18.

․ Bolli GB. et al. Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). Diabet Med. 2014 Feb;31(2):176-84.

․ Rosenstock J. et al. Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). J Diabetes Complications. 2014 Jan 28.

․ Pinget M, et al. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7.

․ Riddle MC. et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96.

․ Seino Y. et al. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012 Oct;14(10):910-7.

․ Riddle MC. et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503.

․ Schmidt L. et al. A systematic review and meta-analysis of the efficacy of lixisenatide in the treatment of patients with type 2 diabetes. Diabetes Obes Metab. 2014 Jan 29.