보험인정기준 상세내용

■ 고시 신설 전체내용

1. 허가사항 범위 내에서 투여 시 요양급여함을 원칙으로 함.

2. 허가사항 범위를 초과하여 아래와 같은 기준으로 투여 시 요양급여를 인정함.

- 아 래 -

가. 허가용량 투여로 배란유도에 실패한 경우 1일 최대 250mg까지 인정

나. 남성 불임증(과소약정자증·비폐쇄성 무정자증)

3. 상기 1. 2. 중 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

“난임시술 비용 급여화”로 과배란유도, 난포성숙 등에 사용하는 동 약제의 급여 기준을 확대하되,

「보조생식술 급여기준」에서 정한 범위에 따라 급여 또는 전액본인부담토록 함.



■ 관련문헌 등

· CURRENT Diagnosis & Treatment: Obstetrics & Gynecology, 11e > Chapter 53. Infertility

· Greenspan’s Basic & Clinical Endocrinology, 9e, 2011> Chapter 13. Female Reproductive Endocrinology and Infertility

· 부인과학 제5판, 대한산부인과학회 > 21장 불임증 22장 보조생식술

· Harrison's Principles of Internal Medicine, 19e chap. 414: Infertility and Contraception, chap. 411 Disorders of the Testes and Male Reproductive System

· Goldman's Cecil Medicine, 25th Edition> chapter 236 Reproductive Endocrinology and Infertility

· Campbell-Walsh Urology, Eleventh Edition. chap. 24> Male Infertility

· American Society for Reproductive Medicine. Medication for Inducing Ovulation. A Guide for patients revised 2012.

· National Institute for Health and Care Excellence (NICE). Fertility problems: assessment and treatment (CG156) Clinical guideline Published: 20 February 2013 Last updated August 2016

· Song D, Shi Y, Zhong Y. et al. Efficiency of mild ovarian stimulation with clomiphene on poor ovarian responders during IVF/ICSI procedures: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:36-43.

· Pilehvari S, ShahrokhTehraninejad E, Hosseinrashidi B. Comparison Pregnancy Outcomes Between Minimal Stimulation Protocol and Conventional GnRH Antagonist Protocols in Poor Ovarian Responders. J Family Reprod Health. 2016 Mar;10(1):35-42.

· Hussein Ghanem, Osama Shaeer, Amgad El-Segini. Combination clomiphene citrate and antioxidant therapy for idiopathic male infertility: a randomized controlled trial. Fertility and Sterility 2010;93:2232？5.

· ALAYMAN HUSSEIN et al. Clomiphene Administration for Cases of Nonobstructive Azoospermia: A Multicenter Study. Journal of Andrology, 2005;26:787？791

· Lass A, McVeigh E, et al. Routine use of r-hFSH follitropin alfa filled-by-mass for follicular development for IVF: a large multicentre observational study in the UK. Reprod Biomed Online. 2004 Dec;9(6):604-10.

· Hossein-Rashidi B,？Khandzad B,？Shahrokh-Tehraninejad E,？Bagheri M,？Gorginzadeh M. Recombinant FSH Compared to？Clomiphene？Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial. J Family Reprod Health.？2016 Mar;10(1):42-8.

· Recombinant versus urinary gonadotrophins for triggering ovulation in assisted conception. Human Reproduction Vol.20, No.8 pp. 2061？2073, 2005