Extended indication Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic
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
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).
Proprietary name Elonva
Manufacturer Organon
Portfolio holder 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 Positive CHMP opinion
Additional comments 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
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 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

< 375

Market share is generally not included unless otherwise stated.

References (1) Expertopinie. (2) NVOG.
Additional comments 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
References medicijnkosten.nl
Additional comments 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

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.

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.