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[249] 기타의 호르몬제
구 분	세부인정기준 및 방법		사유
	현 행	개 정(안)
[249] Long-acting octreotide 주사제 (품명:산도스타틴라르주사10밀리그램 등)	허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 하며, 허가사항 범위를 초과하여 아래와 같은 기준으로 투여하는 경우에는 약값 전액을 환자가 부담토록 함. - 아 래 - ○ 카르시노이드 증후군을 나타내지 않으나 옥트레오스캔 양성 또는 생물표지자(Biomarkers)가 상승된 수술이 불가능한 전이성 진행성 내분비 종양 환자에게 투여 시	1. 허가사항 범위 내에서 투여 시 요양급여를 함을 원칙으로 함. 2. 허가사항 범위(효능ㆍ효과 등)를 초과하여 아래와 같은 기준으로 투여 시에도 요양급여를 인정함. - 아 래 - ○ 카르시노이드 증후군을 나타내지 않으나 옥트레오스캔 양성 또는 생물표지자(Biomarkers)가 상승된 수술이 불가능한 전이성 진행성 내분비 종양 환자에게 투여 시	임상문헌, 학회의견, 기심의사례 등을 참고하여 허가범위 초과하여 약값 전액본인부담하는 항목을 요양급여로 인정함.
※ 관련근거 ․□AHFS Drug Information (2006) p.3742 ․□Cinical Oncology 3rd (2004) p.1635 ․□NCCN Clinical Practice Guidelines in Oncology V.3.2017, Neuroendocrine Tumors ․□Octreotide acetate long-acting release in patients with metastatic neuroendocrine tumors pretreated with lanreotide, Annals of Oncology 11:1127-1130, 2000
※ 관련근거 · Harrison's Principles of Internal Medicine, 20e · Comprehensive Clinical Nephrology, 6th ed, 2019 · Current Diagnosis & Treatment: Emergency Medicine, 8e, 2017 · Pharmacotherapy: A pathophysiologic Approach, 10e, 2017 · KDIGO Anemia in Chronic Kidney Disease, 2012 · Chronic kidney disease: managing anaemia. NICE guideline Published: 3 June 2015 · Mikhail A et al. Renal association clinical practice guideline on anaemia od Chronic Kidney Disease, BMC Nephrology (2017) 18:345 · Locatelli F et al. Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice(ERBP), 2008 · Yamamoto H et al. 2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease · Collister D, Komenda P et al. The Effect of Erythropoietin-Stimulating Agents on Health-Related Quality of Life in Anemia of Chronic Kidney Disease: A Systematic Review and Meta-analysis. Ann Intern Med. 2016 Apr 5;164(7):472-8. · Palmer SC, Saglimbene V et al. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2014 Dec 8;(12):CD010590. · Johansen KL, Finkelstein FO et al. Systematic review of the impact of erythropoiesis-stimulating agents on fatigue in dialysis patients. Nephrol Dial Transplant. 2012 Jun;27(6):2418-25. · Palmer SC, Navaneethan SD et al. Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med. 2010 Jul 6;153(1):23-33. · Inrig JK, Barnhart HX et al. Effect of hemoglobin target on progression of kidney disease: a secondary analysis of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) trial. Am J Kidney Dis. 2012 Sep;60(3):390-401. · Patel M, Thimons DG et al. An open-label, randomized, multicenter, controlled study of epoetin alfa for the treatment of anemia of chronic kidney disease in the long term care setting. J Am Med Dir Assoc. 2012 Mar;13(3):244-8.

[249] 기타의 호르몬제
구 분	세부인정기준 및 방법		사유
	현 행	개 정(안)
[249] Octreotide 주사제 (품명 : 산도스타틴주 등)	1. 허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 하며, 허가사항 범위(효능ㆍ효과)를 초과하여 아래와 같은 기준으로 투여한 경우에도 요양급여를 인정함. - 아 래 - 가. ∼ 나. ( 생 략 ) < 추 가 > 2. 허가사항 범위를 초과하여 아래와 같은 기준으로 투여하는 경우에는 약값 전액을 환자가 부담토록 함. - 아 래 - 가. 유미흉(Chylothorax), 유미복수(Chylous ascites)에 1일 0.3mg씩 7～14일간 투여한 경우(소아의 경우 적의 증감가능) 나. 위ㆍ장관계 수술 후 문합부위 누출에 치료목적으로 투여한 경우 다. 췌장관련 수술 후 합병증 치료에 투여한 경우	1. 허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 하며, 허가사항 범위(효능ㆍ효과)를 초과하여 아래와 같은 기준으로 투여한 경우에도 요양급여를 인정함. - 아 래 - 가. ∼ 나. ( 현행과 같음 ) 다. 유미흉(Chylothorax), 유미복수(Chylous ascites)에 1일 0.3mg씩 7～14일간 투여한 경우(소아의 경우 적의 증감가능) 2. 허가사항 범위를 초과하여 아래와 같은 기준으로 투여하는 경우에는 약값 전액을 환자가 부담토록 함. - 아 래 - < 삭 제 > 가. 위ㆍ장관계 수술 후 문합부위 누출에 치료목적으로 투여한 경우 나. 췌장관련 수술 후 합병증 치료에 투여한 경우	임상문헌, 학회의견, 기심의사례 등을 참고하여 유미흉(Chylothorax), 유미복수(Chylous ascites)에 요양급여를 인정함.
※ 관련근거 ㆍHarrison's Principle of Internal Medicine, 20th Edition, Copyright ⓒ 2018. > Chapter 288: Disorders of the Pleura ㆍMurray & Nadel's Textbook of Respiratory Medicine, 6th ed. Copyright ⓒ 2016 > Chapter 81. Pneumothorax, Chylothorax, Hemothorax, and Fibrothorax ㆍCurrent Therapy in Vascular and Endovascular Surgery. Fifth Edition. Copyright ⓒ 2014 ㆍ김원곤외. 흉부외과학. 제2판. 고려의학. 2000. 제10장 흉막 및 흉막강의 질환 P103-105 ㆍBellini C, et al, Octreotide for congenital and acquired chylothorax in newborns: A systematic review. J Paediatr Child Health. 2018 Aug;54(8):840-847. ㆍHayashibara N, et al, Efficacy of octreotide against chylothorax following lateral neck dissection for thyroid cancer: A case report. Int J Surg Case Rep. 2016;21:107-10. ㆍGupta A, et al, Octreotide in malignant chylothorax: a case report. BMJ Support Palliat Care. 2016 Mar;6(1):122-4. ㆍBarili F et al. Administration of octreotide for management of postoperative high-flow chylothorax. Ann Vasc Surg. 2007 Jan;21(1):90-2. ㆍChen-Scarabelli C et al. Use of octreotide, a long-acting somatostatin analogue, in the treatment of chylothorax of idiopathic etiology. Minerva Chir. 2006 Apr;61(2):155-8. ㆍMincher L et al. The successful treatment of chylous effusions in malignant disease with octreotide. Clin Oncol . 2005 Apr;17(2):118-21. ㆍZiedalski TM et al. Chylothorax after heart/lung transplantation. J Heart Lung Transplant. 2004 May; 23(5): 627-31. ㆍEvans J et al. Chylous effusions complicating lymphoma: a serious event with octreotide as a treatment option. Hematol Oncol. 2003 Jun;21(2):77-81. <유미복수> ㆍSchwartz's Principles of Surgery, 10e. Copyright ⓒ 2015 by McGraw-Hill > Chapter 28: Small Intestine ㆍCampbell-Walsh Urology Eleventh Edition. Copyright ⓒ 2016 by Elsevier ㆍNelson Textbook of Pediatrics, Twentieth Edition. Copyright ⓒ 2016 by Elsevier, Inc. > Chapter 370. Ascites ㆍYang C, et al, Successful management of chylous ascites with total parenteral nutrition and octreotide in children. Nutr Hosp. 2013 Nov 1;28(6):2124-7. ㆍHayashibara N, et al, Efficacy of octreotide against chylothorax following lateral neck dissection for thyroid cancer: A case report. Int J Surg Case Rep. 2016;21:107-10 ㆍPan W, et al, The application of nutrition support in conservative treatment of chylous ascites after abdominal surgery. Ther Clin Risk Manag. 2016 Apr 15;12:607-12. ㆍNunes G, et al, Idiopathic chylous ascites in a patient with HIV infection: response to total parenteral nutrition and octreotide therapy. Clin J Gastroenterol. 2018 Jun;11(3):235-239. ㆍAoki H, et al. Milk-based test as a preventive method for chylous ascites following pancreatic resection. Department of Surgery.2010;27(5):427-32. ㆍTalluri S.K, et al. Chylous ascites. North Am J Med Sci . 2011; 3(9): 438-40. ㆍLee PH, et al. Octreotide therapy for chylous ascites in a chronic dialysis patient. Nephrology (Carlton). 2005 Aug;10(4):344-7. ㆍIaria M, et al. Chylous ascites following laparoscopic living donor nephrectomy. American Journal of Transplantation 2011;11(2):514. ㆍDietrich S, et al. Chylous Ascites in a Patient with Inflammatory Myofibroblastic Tumor. Case Rep Oncol. 2009 Aug 1;2(2):144-149. ㆍPessotti CF, et al. Use of octreotide in the treatment of chylothorax and chyloperitoneum. Arq Bras Cardiol. 2011 Aug;97(2):e33-e36. ㆍHuang Y, et al. Successful management of congenital chylous ascites in a premature infant using somatostatin analogue. Indian J Pediatr. 2011 Mar;78(3):345-7. ㆍTakeuchi K, et al. Successful medical treatment with octreotide for chyloperitoneum following paraaortic lymphadenectomy in the treatment of gynecologic malignancies a report of 2 cases. Journal of Reproductive Medicine for the Obstetrician and Gynecologist 2011;56(1-2):75-7. ㆍBaiocchi G. Chylous ascites in gynecologic malignancies: cases report and literature review. Arch Gynecol Obstet. 2010; 281(4): 677-81. ㆍZhou DX, et al. The effectiveness of the treatment of octreotide on chylous ascites after liver cirrhosis. Dig Dis Sci. 2009 Aug;54(8):1783-8. ㆍLegnani G, et al. Resolution of a postoperative chylous ascites using octreotide therapy: Case report and literature review. Chirurgia. 2009;22(4):207-9.