Darolutamide Medicine 08 December 2020 Extended indication Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT. Therapeutic value No estimate possible yet Total cost € 17,500,000.00 Registration phase Clinical trials Product Active substance Darolutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT. 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 Androgreenreceptor blokker. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2021 Expected Registration August 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant verwacht indiening in het vierde kwartaal van 2021 en registratie in het derde kwartaal van 2022. Therapeutic value Current treatment options Docetaxel met ADT of tweede generatie anti-androgeen (abiraterone, enzalutamide, apalutamide) met 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 600 mg References ARASENS (NCT02799602); Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Bron: NKR en ARCHES Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8226 in totaal. Maximaal 20% gaat het om gemetastaseerde hormoon gevoelige prostaatkanker (n=1.645). Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaat kankerpatiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: maximaal 500 patiënten die reëel gezien in aanmerking zullen komen. Expected cost per patient per year Cost € 30,000.00 - 40,000.00 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 Additional remarks Moet concurreren met enzalutamide en apalutamide dus de prijs zal vergelijkbaar zijn. Potential total cost per year Total cost € 17,500,000.00 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