Belzutifan

Extended indication	Somatrogon monotherapy for treatment of growth hormone deficiency in adults
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Somatrogon
Domain	Metabolism and Endocrinology
Reason of inclusion	Indication extension
Main indication	Metabolic diseases
Extended indication	Somatrogon monotherapy for treatment of growth hormone deficiency in adults
Proprietary name	Ngenla
Manufacturer	Pfizer
Portfolio holder	Pfizer
Mechanism of action	Hormonal therapy
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)
Additional remarks	Dit geneesmiddel is in 2022 geregistreerd en vergoed voor kinderen en adolescenten vanaf 3 jaar. Dit betreft de indicatieuitbreiding naar volwassenen.

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	June 2024
Expected Registration	May 2025
Orphan drug	Yes
Registration phase	Registration application pending
Additional remarks	Verwachte registratie aan de hand van inschatting van de fabrikant.

Current treatment options	Dagelijkse somatropine injecties, TransCon Growth Hormone, somapacitan
Therapeutic value	No estimate possible yet
Frequency of administration	1 times a week
References	NCT01909479
Additional remarks	Behandelduur is persoonsafhankelijk.

There is currently nothing known about the expected patient volume.

Cost	< 26,112.98
References	Medicijnkosten.nl
Additional remarks	Kosten Ngenla 24 mg: €219,19 (incl. BTW), Ngenla 60 mg: €545,48 (incl. BTW) (1). Een wekelijkse behandeling met 60 mg kost €26.112,98 (excl. BTW) p.p.p.j. (€545,48/1,09∗52,18).

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.