Darolutamide Medicine 03 December 2024 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 Total cost Registration phase Registration application pending Product Active substance Darolutamide Domain Oncology Reason of inclusion Indication extension IND 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) Current proprietary name Already available biosimilars / generics Proprietary name Nubeqa Manufacturer Bayer Portfolio holder Mechanism of action Antiandrogen Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Androgreenreceptorblokker Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2024 Expected Registration September 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice 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 Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 600 mg References NCT04736199 (ARANOTE) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 39,942.00 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. 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks