Enclomifene Medicine 09 January 2018 Extended indication Secondary hypogonadism Therapeutic value No judgement Total cost Registration phase Negative CHMP opinion Product Active substance Enclomifene Domain Metabolism and Endocrinology Reason of inclusion Main indication Hormonal disorders Extended indication Secondary hypogonadism Current proprietary name Already available biosimilars / generics Proprietary name EnCyzix Manufacturer Repros Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date October 2016 Expected Registration 2018 Orphan drug No Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP januari 2018, geen herbeoordeling aangevraagd. Therapeutic value Current treatment options Clomid, is wel off-label, dit middel is een trans isomeer hiervan. Of testosteron/HCG substitutie. Valt in SERM groep (selective oestrogen receptor modulator). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 12,5 of 25 mg References Additional remarks Behandelduur variëert van maanden tot jaren. Expected patient volume per year Patient volume < 3,200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 20% van de mannen die nu HCG gebruiken en de mannen die nu clomifen gebruiken (kleine groep). Expected cost per patient per year Cost References Additional remarks Meerkosten. Patiënten gebruikne HCG en testosteron. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Hypogonadotrope hypogonadisme in obese mannen. References Additional remarks In obese mannen kunnen je ook hypogonadotrope hypogonadisme vinden. Dit is een grijs gebied, maar een met veel patiënten. In vrouwen verwacht ik niet dat het een toevoeging is op de huidige middelen en minder effectief. Other information Additional remarks