고시 개정 사유
○국내·외 허가사항, 관련문헌(교과서, 임상진료지침, 임상연구문헌 등) 및 학회(전문가)의견 등을 참조하여 hMG와 Follitropin delta의 병용 투여 인정
-단, Follitropin delta는 기존약제들과 단위가 다른 점 고려하여 hMG와 병용투여 시 동 약제의 허가사항을 참고하여 병용 약제의 인정 총 용량 범위내에서 투여하도록 함
※관련근거
·Williams Gynecology, 4e (2020) > CHAPTER 21: Treatment of the Infertile Couple
·부인과학 Gynecology 제5판, (대한산부인과학회) Chapter 22. 보조생식술
·부인과 내분비학 (대한산부인과내분비학회)
·NICE Clinical guideline; Fertility problems: assessment and treatment (2017)
·ESHRE guideline; OVARIAN STIMULATION FOR IVF/ICSI, 2019
·American Society for reproductive medicine. medications for inducing ovulation. A guide for patients (2016)
·Lunenfeld et al., The Development of Gonadotropins for Clinical Use in the Treatment of Infertility, Frontiers in Endocrinology (2019)
·Bissonnette et al., Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin, American Society for Reproductive Medicine (2020)
·Andersen et al., Individualized versus conventionalovarian stimulation for in vitro fertilization: a multicenter,randomized, controlled,assessor-blinded, phase3 noninferiority trial, American Society for Reproductive Medicine (2017)
·Yacoub et al., Low risk of OHSS with follitropin delta use in women with different polycystic ovary syndrome phenotypes: a retrospective case series, Journal of Ovarian Research (2021)
·Bosch et al. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial, Reproductive biomedicine online (2019)
·Qiao et al, A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients, Human Reproduction, Vol.36, No.9 (2021)
·PBAC (2017), SMC (2017)