2. 허가사항 범위(효능·효과 및 용법·용량)를 초과하여 다낭성난소증후군(PCOS) 환자의 불임증 치료에 투여 시 요양급여를 인정하되, 보조생식술에 투여 시에는 「보조생식술 급여기준」 범위 내에서 요양급여를 인정하며, 비급여로 실시한 경우에는 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 PCOS 환자의 불임증 치료에 급여인정하되,
「보조생식술 급여기준」에서 정한 범위에 따라 급여 또는 전액본인부담토록 함
■ 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
？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