Ospemifene Medicine 07 December 2021 Extended indication Extension of indication in vulvar and vaginal atrophy (VVA) patients treated with ospemifene compared to 1)patients newly prescribed SERMs for oestrogen- deficiency conditions or breast cancer prevention. 2) the incidence in untreated VVA patients. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ospemifene Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Extension of indication in vulvar and vaginal atrophy (VVA) patients treated with ospemifene compared to 1)patients newly prescribed SERMs for oestrogen- deficiency conditions or breast cancer prevention. 2) the incidence in untreated VVA patients. Current proprietary name Already available biosimilars / generics Proprietary name Senshio Manufacturer Shionogi Portfolio holder Mechanism of action Unknown 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 Unknown ATMP Unknown Submission date June 2021 Expected Registration April 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 60 mg References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 605.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References NHS Commissioning Statement Additional remarks De jaarlijkse kosten in het VK zijn door de NHS berekend als £514.68 per jaar. Omgerekend naar euro zou dit betekenen op jaarbasis €604,58 per patiënt. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks