보험인정기준 상세내용

■ 고시 신설 전체내용



1. 허가사항 범위 내에서 요양 급여를 인정함.



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

- 아 래 -

가. 투여대상

성선기능저하, 난소기능부전으로 인한 저에스트로겐증 환자(예: 터너증후군 등)

나. 투여연령

만 11세 이상 여성 환자

※ 동 약제 투여 시에는 환자의 연령, 성장 속도, 성성숙도(Tanner stage) 등을 고려하여 담당진료의사의 전문의학적 판단에 따라 적정 투여하며, 식약처 허가사항의 사용상의 주의사항(소아에 대한 투여 등)을 반드시 참고하여 신중히 투여하도록 함.



3. 허가사항 범위를 초과하여 보조생식술에 투여 시 [일반원칙] 보조생식술에 사용되는 호르몬 약제 급여기준에 따라 요양급여를 인정함.



■ 고시 신설 고시번호(시행일자)

고시 제2023-184호(2023.10.1.)



■ 고시 신설 사유

○Estradiol hemihydrate 경구제(품명: 프레다정1mg 등)의 급여기준 신설



■ 관련문헌 등

· 내분비대사학 3판(2022)_대한내분비학회

· 부인과 내분비학 2th(2022)_대한산부인과내분비학회

· 소아내분비학 3th(2014)_대한소아내분비학회

· Harrison's Principles of Internal Medicine, 21e

· Smith & Tanagho's General Urology, 19e

· Greenspan's Basic & Clinical Endocrinology, 10e

· Zitelli and Davis' Atlas of Pediatric Physical Diagnosis, 9, 342-381

· Current Medical Diagnosis & Treatment 2023

· Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting, European Journal of Endocrinology (2017) 177, G1？G70

· Current best practice in the management of Turner syndrome, Ther Adv Endocrinol Metab 2018, Vol. 9(1) 33？40

· Turner syndrome: French National Diagnosis and Care Protocol (NDCP; National Diagnosis and Care Protocol, Orphanet Journal of Rare Diseases (2022) 17:261

· ESHRE Guideline: management of women with premature ovarian insufficiency(2016)

· Optimal Pubertal Induction in Girls with Turner Syndrome Using Either Oral or Transdermal Estradiol: A Proposed Modern Strategy, Horm Res Paediatr 2019;91:153？163

· CLINICAL PRACTICE GUIDELINE Care of Girls and Women with Turner Syndrome: A Guideline of the Turner Syndrome Study Group, The Journal of Clinical Endocrinology & Metabolism 92(1):10？25(2007)

· [NDTP] Position statement on the diagnosis and management of premature/primary ovarian insufficiency (except Turner Syndrome). Annales d’Endocrinologie 82 (2021) 555？571

· Line Cleemann et al., Effect of Dosage of 17ß-Estradiol on Uterine Growth in Turner Syndrome―A Randomized Controlled Clinical Pilot Trial. J Clin Endocrinol Metab 105: e715？e723, 2020

· Charmian A. Quigley et al., Effects of Low-Dose Estrogen Replacement During Childhood on Pubertal Development and Gonadotropin Concentrations in Patients With Turner Syndrome: Results of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Clin Endocrinol Metab 99: E1754？E1764, 2014

· Jose´ I Labarta et al., Individualised vs fixed dose of oral 17b-oestradiol for induction of puberty in girls with Turner syndrome: an open-randomised parallel trial. European Journal of Endocrinology (2012) 167 523？529

· E. M. N. Bannink et al., Puberty induction in Turner syndrome: results of oestrogen treatment on development of secondary sexual characteristics, uterine dimensions and serum hormone levels. Clinical Endocrinology (2009) 70, 265？273

· Feras Zaiem MD et al., ORAL VERSUS TRANSDERMAL ESTROGEN IN TURNER SYNDROME: A SYSTEMATIC REVIEW AND META-ANALYSIS. Endocrine Practice Volume 23, Issue 4, April 2017, Pages 408-421

· L. Torres-Santiago et al., Metabolic Effects of Oral Versus Transdermal 17-Estradiol (E2): A Randomized Clinical Trial in Girls With Turner Syndrome. J Clin Endocrinol Metab, July 2013, 98(7):2716？2724

· Ronald J. Ruggiero et al., ESTROGEN: PHYSIOLOGY, PHARMACOLOGY, AND FORMULATIONS FOR REPLACEMENT THERAPY. J Midwifery Womens Health 2002;47:130？8

· Soo？Min Kim et al., Serum estradiol level according to dose and formulation of oral estrogens in postmenopausal women. Scientific Reports (2021) 11:3585

· Moon Young Seo et al., Trend of Menarcheal Age among Korean Girls. J Korean Med Sci. 2020 Dec 21;35(49):e406