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Darolutamide

Nubeqa

Extended indication Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatm
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

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

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

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

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).

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.