Estetrol Medicine 03 June 2025 Extended indication Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal women. Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Estetrol Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in hysterectomised postmenopausal women. Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses. Current proprietary name Already available biosimilars / generics Proprietary name Fylrevy Manufacturer Gedeon Portfolio holder Gedeon Mechanism of action Hormonal therapy Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2025 Expected Registration March 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks De fabrikant geeft aan geen dossier in te dienen in Nederland Therapeutic value Current treatment options HST Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Abstract menopause society; gunstig effect op vasomotore klachten, maar geen effect op bloeddruk. Nog geen resultaten om een onderbouwing op te baseren. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT04209543 (E4Comfort Study I); NCT04090957 (E4Comfort Study II) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Richtlijnendatabase Additional remarks In Nederland ervaren jaarlijks ongeveer een miljoen vrouwen tussen de 40 en 60 jaar overgangsklachten, waarvan 80% in meer of mindere mate last heeft van vasomotorische symptomen zoals opvliegers en nachtelijk zweten. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks Estetrol in combinatie met drospirenon is momenteel gecommercialiseerd als contraceptie middel.