Extended indication Extension of indication to include treatment of adolescent males (14 to less than 18 years) with hy
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Corifollitropin alfa
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
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.
Proprietary name Elonva
Manufacturer Organon
Mechanism of action Hormonal therapy
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Pituitary gonadotropin

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2021
Expected Registration June 2022
Orphan drug No
Registration phase Registration application pending
Additional comments 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
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.
Frequency of administration 1 times every 2 weeks
Dosage per administration 100 μg of 150 μg
References NCT03019575
Additional comments 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.

Additional comments 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

References medicijnkosten
Additional comments ELONVA 150 injectievloeistof 300MCG/ML WWSP 0,5ML. Gemiddelde prijs per dag €578,63

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.