보험인정기준 상세내용

■ 고시 신설 전체내용

1. [일반원칙] 당뇨병용제 “세부사항” 범위 내에서 투여 시 요양급여를 인정함.

2. 허가사항 범위(효능？효과 및 용법？용량)를 초과하여 metformin에 부작용이 있거나 효과가 없는 다낭성난소증후군(PCOS) 환자의 불임증 치료에 투여 시 약값 전액을 환자가 부담토록 함.



■ 고시 신설 고시번호(시행일자)

고시 제2017-180호(2017.10.1.)



■ 고시 신설 사유

동 약제의 교과서, 가이드라인 및 임상연구문헌 등을 참조하여 metformin에 부작용이 있거나 효과가 없는 PCOS 환자의 불임증 치료(보조생식술 포함)에 급여인정 하되, 약값 전액 환자부담하는 것으로 기준 설정함.



■ 관련문헌 등

？식품의약품안전처 허가사항

？부인과학 제5판(대한산부인과학회) - 20장 내분비이상

？NICE - Fertility problems: assessment and treatment(CG156)

？Harrison's online (Harrison's Principles of Internal Medicine 19e, 2015) - 414: Infertility and Contraception

？Williams Gynecology(3e, 2016) - CHAPTER 17: Polycystic Ovarian Syndrome and Hyperandrogenism

？Leopoldo O Tso et al, Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome, Cochrane Database of Systematic Reviews 2014, Issue 11

？Palomba et al.., Metformin and gonadotropins for ovulation induction in patients with polycystic ovary syndrome: a systematic review with meta-analysis of randomized controlled trials. Reproductive Biology and Endocrinology 2014, 12:3

？Stefano Palomba, M.D., Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial. Fertility and Sterility Vol. 96, No. 6, December 2011

？John E. Nestler, M.D., EFFECTS OF METFORMIN ON SPONTANEOUS AND CLOMIPHENE-INDUCED OVULATION IN THE POLYCYSTIC OVARY SYNDROME N Engl J Med 1998;338:1876-80.

？Kashyap S, Wells GA, Rosenwaks Z., Insulin-sensitizing agents as primary therapy for patients with polycystic ovarian syndrome. Hum Reprod. 2004 Nov;19(11):2474-83. Epub 2004 Sep 9.

？Tang T et al, Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility, Cochrane Database of Systematic Reviews 2012, Issue 5