Corifollitropin alfa Medicine 07 December 2021 Extended indication Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG). Therapeutic value No estimate possible yet Total cost € 4,877,250.00 Registration phase Positive CHMP opinion Product Active substance Corifollitropin alfa Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG). Current proprietary name Already available biosimilars / generics Proprietary name Elonva Manufacturer Organon Portfolio holder Organon 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 Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie verkregen in april 2022. 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 Average 64 week / weeks Frequency of administration 1 times every 2 weeks Dosage per administration 100 μg (voor patiënten <60kg) of 150 μg (voor patiënten >60kg) 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 < 375 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) Expertopinie. (2) NVOG. Additional remarks Het zal gaan om een klein aantal patiënten, wellicht 20 tot 25 per jaar per centra (1). Er zijn 15 grote centra, daarom zal het maximaal 375 patiënten betreffen die in aanmerking komen voor deze behandeling (2). Expected cost per patient per year Cost € 12,210.00 - 13,802.00 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 medicijnkosten.nl Additional remarks Prijs incl. BTW: Elonva 100 injvlst 200mcg/ml wwsp 0,5ml Corifollitropine alfa € 511,90 per stuk. Elonva 150 injvlst 300mcg/ml wwsp 0,5ml Corifollitropine alfa € 578,63 per stuk. Kosten in jaar 1: Prijs/1,09(excl. BTW)*52/2(1*per 2 weken in een jaar) = 12210 - 13802 (range afhankelijk van gewicht) Potential total cost per year Total cost € 4,877,250.00 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