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 Bayer 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 Therapeutic value Current treatment options Docetaxel + ADT, abirateron + ADT, enzalutanide + ADT, apalutamide + ADT, abirateron + docetaxel + ADT. 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 600mg References NCT04736199 (ARANOTE) Additional remarks Treatment duration: At the data cutoff date for the primary analysis, the median treatment duration was 24.2 months in the darolutamide group with 53.8% of patients still receiving darolutamide treatment. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het is de verwachting dat darolutamide dezelfde plaats in de behandeling krijgt als enzalutamide en apalutamide (beide in combinmatie met ADT). Beide behandelingen worden vanwege de hogere kosten vooral ingezet bij patiënten die geen (generiek) abirateron kunnen verdragen. Het verwachte marktaandeel zal daarom laag zijn. Ter illustratie: in 2022 werden 39 en 35 mHSPC patiënten behandeld metenzalutamide en apalutamide, repectievelijk (Bron: pakketadvies darolutamide). 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 300mg: €29,80 (inclusief BTW) (1). Een jaar behandeling kost dan €39.942 (exclusief 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