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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. GLP-1 수용체 효능제 <신 설> 1) 투여대상 Metformin+Sulfonylurea계 약제 병용투여로 충분한 혈당조절을 할 수 없는 환자 중 가) 체질량지수(BMI: Body mass index)≥30kg/㎡인 비만환자 나) Insulin 요법을 할 수 없는 환자 2) 투여방법 3종 병용요법(Metformin+ Sulfonylurea+GLP-1 수용체 효능제)을 인정 <신 설> 라. ~ 바. 생략 ※ 대상약제 [경구제 중 단일제] ⋅ Biguanide계: Metformin HCl ⋅ Sulfonylurea계: Glibenclamide, Gliclazide, Glimepiride, Glipizide ⋅ Meglitinide계: Mitiglinide calcium hydrate, Nateglinide, Repaglinide ⋅ α-glucosidase inhibitor계: Acarbose, Miglitol, Voglibose ⋅ Thiazolidinedione계: Lobeglitazone sulfate, Pioglitazone HCl, Rosiglitazone maleate ⋅ DPP-IV inhibitor계: Alogliptin, <신 설>, Gemigliptin, Linagliptin, Saxagliptin, Sitagliptin phosphate, Teneligliptin, Vildagliptin ⋅ SGLT-2 inhibitor계: Dapagliflozin, Ipragliflozin [경구제 중 복합제] ⋅ Glibenclamide+Metformin HCl, Gliclazide+ Metformin HCl, Glimepiride+Metformin HCl ㆍ Mitiglinide calcium hydrate+Metformin HCl, Nateglinide +Metformin HCl, Repaglinide + Metformin HCl ㆍ Voglibose+Metformin HCl ㆍ Pioglitazone HCl+Metformin HCl, Rosiglitazone maleate+ Metformin HCl ㆍ Pioglitazone HCl+Glimepiride, Rosiglitazone maleate+ Glimepiride ㆍ Alogliptin+Metformin HCl, Gemigliptin +Metformin HCl, Linagliptin+Metformin HCl, Saxagliptin+Metformin HCl, Sitagliptin phosphate+Metformin HCl, <신 설> Vildagliptin +Metformin HCl ㆍ Alogliptin+Pioglitazone HCl [주사제] 생략	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) 경구제와 병용요법 가) 투여대상 Metformin+Sulfonylurea계 약제 병용투여로 충분한 혈당조절을 할 수 없는 환자 중 (1) 체질량지수(BMI: Body mass index)≥25kg/㎡ 또는 (2) Insulin 요법을 할 수 없는 환자 나) 투여방법 3종 병용요법(Metformin+ Sulfonylurea+GLP-1 수용체 효능제)을 인정 2) Insulin와 병용요법 가) 투여대상 기저 Insulin(Insulin 단독 또는 Metformin 병용) 투여에도 HbA1C가 7% 이상인 경우 나) 투여방법 기저 Insulin+GLP-1 수용체 효능제(+ Metformin)을 인정 라. ~ 바. 현행과 같음 ※ 대상약제 [경구제 중 단일제] ⋅ Biguanide계: Metformin HCl ⋅ Sulfonylurea계: Glibenclamide, Gliclazide, Glimepiride, Glipizide ⋅ Meglitinide계: Mitiglinide calcium hydrate, Nateglinide, Repaglinide ⋅ α-glucosidase inhibitor계: Acarbose, Miglitol, Voglibose ⋅ Thiazolidinedione계: Lobeglitazone sulfate, Pioglitazone HCl, Rosiglitazone maleate ⋅ DPP-IV inhibitor계: Alogliptin, Anagliptin, Gemigliptin, Linagliptin, Saxagliptin, Sitagliptin phosphate, Teneligliptin, Vildagliptin ⋅ SGLT-2 inhibitor계: Dapagliflozin, Ipragliflozin [경구제 중 복합제] ⋅ Glibenclamide+Metformin HCl, Gliclazide+ Metformin HCl, Glimepiride+Metformin HCl ㆍ Mitiglinide calcium hydrate+Metformin HCl, Nateglinide +Metformin HCl, Repaglinide + Metformin HCl ㆍ Voglibose+Metformin HCl ㆍ Pioglitazone HCl+Metformin HCl, Rosiglitazone maleate+ Metformin HCl ㆍ Pioglitazone HCl+Glimepiride, Rosiglitazone maleate+ Glimepiride ㆍ Alogliptin+Metformin HCl, Gemigliptin +Metformin HCl, Linagliptin+Metformin HCl, Saxagliptin+Metformin HCl, Sitagliptin phosphate+Metformin HCl, Teneligliptin+ Metformin HCl, Vildagliptin+Metformin HCl ㆍ Alogliptin+Pioglitazone HCl [주사제] 현행과 같음	- 동 약제의 허가사항, 교과서, 가이드라인 및 임상연구문헌 등을 참조하여 인슐린 병용 투여시에도 급여 인정하며, 경구제와 병용시 투여대상의 BMI 기준을 완화함. - 신규 등재 예정인 약제 Anagliptin(가드렛정100밀리그램)은 DPP-IV 저해제와 동일 급여기준을 적용함. -‘약제급여목록 및 급여상한금액표’에 Teneligliptin+metformin 복합제(테넬리아엠정)가 등재 예정임에 따라 성분명을 명시함.

※ 관련근거

․ 식품의약품안전처 허가사항

․ Martindale: The Complete Drug Reference - Management of diabetes mellitus (Latest modification: 17-May-2013)

․ Endocrinology: Adult and Pediatric, 7e(2015) - Chapter 48 Management of Type 2 Diabetes Mellitus

․ Harrison's online (Harrison's Principles of Internal Medicine 19e, 2015) - CHAPTER 418: Diabetes Mellitus: Management and Therapies

․ 대한당뇨병학회: 당뇨병 진료지침 2013.

․ ADA Guideline: Standards of medical care in diabetes 2015(Jan, 2015)

․ AACE/ACE Guideline: AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY –CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN – 2015(Apl, 2015)

․ Conrad Eng, Caroline K Kramer, Bernard Zinman, Ravi Retnakaran, Glucagon-like peptide-1 receptor agonist and basal insulin combination tre atment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet 2014; 384: 2228–34

․ Arnolds S, et al. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study Diabetes Care, Volume 33, Number 7, July 2010. 1509-1515

․ Buse JB, et al. Use of Twice-Daily Exenatide in Basal insulin-Treated Patients With Type 2 Diabetes Annals of Internal Medicine 2011;154:103-1251

․ Michaela D, et al. Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes Diabetes Care, 2014. Online published Aug. 22

․ Riddle MC, et al. Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by Established Basal Insulin Diabetes Care. 2013 Sep;36(9):2489-96

․ Seino Y, et al. Randomized, double-blinded, 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 Diabetes, Obesity and Metabolism 14: 910–917, 2012.

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

․ KEN Y T, et al. GLP-1 receptor agonists in type 2 diabetes - NICE guidelines versus clinical practice Br J Diabetes Vasc Dis. 2014:14:52-59

․ Aetna: Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan(Sep 2014) ․ Subject: Insulins - Fully-Insured Plans

․ PBAC: Public Summary Document – Exenatide, pre-filled injection pen, 5 micrograms per dose, 10 micrograms per dose, Byetta®, November 2008

․ Scottish Medicines Consortium: lixisenatide 10microgram/0.2mL, 20microgram/0.2mL solution for injection in pre-filled disposable pen (Lyxumia®) SMC No. (903/13)

․ Scottish Medicines Consortium: exenatide twice-daily in combination with insulin (Byetta) SMC No. (785/12)

․ Harrison's Online, 19th ed Chapter 418 Diabetes Mellitus: Management and Therapies> Pharmacologic Treatment of Diabetes> Type 2 Diabetes Mellitus> Glucose-Lowering Agents

․ Japan Diabetes Society, Treatment Guide for Diabetes(2012-2013), Pharmacotherapy > Oral drug treatment

․ Hae Kyung Yang et al. A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naive patients with type 2 diabetes. Endocrine Journal. 2015 May;62(5):449-462

․ S.-M. Jin et al. Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension. Diabetes Obes Metab. 2015 May;17(5):511-5