Favourable opinion for reimbursement of ELONVA (corifollitropin alfa) in the “treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism (HH), in combination with human Chorionic Gonadotropin (hCG)”.
Role in the care pathway?
Role of the medicinal product
The non-comparative nature of the study provided by the pharmaceutical company does not enable the different treatments to be ranked in order to determine the role of ELONVA (corifollitropin alfa) compared to the other therapeutic options recommended and used off-label in HH in adolescent males.
ELONVA (corifollitropin alfa), in combination with human Chorionic Gonadotropin (hCG), is a new treatment option for adolescent males (14 years and older) with hypogonadotropic hypogonadism (HH). This is a first-line treatment for HH in adolescent males (14 years and older).
Clinical Benefit
Substantial
The clinical benefit (CB) of ELONVA (corifollitropin alfa) is substantial in the MA indication extension.
Clinical Added Value
no clinical added value
Considering:
the non-comparative nature of the only study available concerning a sample of 17 patients with acquired HH or congenital HH, it is not possible to quantify the clinical benefit of a combination of corifollitropin alfa and hCG in HH in adolescent males (14 years and older) compared to the therapeutic alternatives recommended and used off-label,
the fact that it is not possible to determine the effect size of ELONVA (corifollitropin alfa) in either congenital HH or acquired HH. Yet these two diseases differ in terms of the extent of the hormone deficiency,
the administration methods for ELONVA (corifollitropin alfa) with a dosage regimen of one injection every two weeks, which is of interest in terms of promoting compliance in adolescents,
the safety profile of ELONVA (corifollitropin alfa), used in combination with hCG, which appears to be favourable,
the Committee deems that ELONVA provides minor clinical added value (CAV V) in the current care pathway, which includes the clinically relevant comparators (see 2.3.1).
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