Darolutamide

Extended indication	Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC)
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Darolutamide
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Prostate cancer
Extended indication	Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC)
Proprietary name	Nubeqa
Manufacturer	Bayer
Mechanism of action	Antiandrogen
Route of administration	Oral
Therapeutical formulation	Film-coated tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	Androgreenreceptorblokker

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	November 2024
Expected Registration	September 2025
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	De minister van VWS heeft de Tweede Kamer begin september 2024 geïnformeerd dat darolutamide (Nubeqa®) in de sluis blijft staan. Dat betekent dat het medicijn niet in het basispakket van de zorgverzekering komt. De minister heeft met de leverancier onderhandeld over een prijsverlaging. Maar het is niet gelukt om tot een akkoord te komen.

Therapeutic value	No estimate possible yet
Frequency of administration	2 times a day
Dosage per administration	600 mg
References	NCT04736199 (ARANOTE)

There is currently nothing known about the expected patient volume.

Cost	39,942.00
References	Medicijnkosten.nl (1)
Additional remarks	Nubeqa tablet filmomhuld 300 mg: €29,80 (incl. BTW) (1). Een jaar behandeling kost dan €39.942 (excl. BTW) (€29,80∗4∗365,24/1,09).

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.