Corifollitropin alfa Medicine 07 December 2021 Extended indication Extension of indication to include treatment of adolescent males (14 to less than 18 years) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG) for Elonva. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Corifollitropin alfa Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Extension of indication to include treatment of adolescent males (14 to less than 18 years) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG) for Elonva. Current proprietary name Already available biosimilars / generics Proprietary name Elonva Manufacturer Organon Portfolio holder Mechanism of action Hormonal therapy Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Pituitary gonadotropin Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2021 Expected Registration June 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Het product is in 2014 geregistreerd in de Verenigde Staten. Therapeutic value Current treatment options Testosteron injectie, testosteron gel en HCG injectie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Aangezien het in combinatie gebruikt zal worden met HCG injecties wordt er niet direct een meerwaarde gezien. Ook is er beperkte literatuur aanwezig om dit te onderbouwen. Een voordeel is het minder frequent prikken. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 100 μg of 150 μg References NCT03019575 Additional remarks CFA administered 100μg (if body weight ≤60kg) or 150μg (if body weight >60kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64). Expected patient volume per year Patient volume 20 - 25 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het zal gaan om een klein aantal patiënten, wellicht 20 tot 25 per jaar als het binnen de indicatie zit. Indien het in plaats van Pregnyl gegeven zal worden zullen de patiëntvolumes mogelijk hoger kunnen oplopen. Expected cost per patient per year Cost References medicijnkosten Additional remarks ELONVA 150 injectievloeistof 300MCG/ML WWSP 0,5ML. Gemiddelde prijs per dag €578,63 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