Darolutamide Medicine 08 December 2020 Extended indication Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT. Therapeutic value Possible added value Total cost € 17,500,000.00 Registration phase Registration application pending Product Active substance Darolutamide Domain Oncology 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 No Submission date March 2022 Expected Registration November 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De indicatie-uitbreiding is in maart 2022 ingediend bij de EMA. De fabrikant verwacht registratie in het vierde kwartaal van 2022. Therapeutic value Current treatment options Docetaxel met ADT of tweede generatie anti-androgeen (abiraterone, enzalutamide, apalutamide) met ADT. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 ARASENS studie heeft zijn primaire eindpunt gehaald. De overall survival (OS) nam significant toe vergeleken met docetaxel en ADT. Duration of treatment Median 41 month / months Frequency of administration 2 times a day Dosage per administration 600 mg References ARASENS (NCT02799602); https://pubmed.ncbi.nlm.nih.gov/35179323/ 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 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 8.226 in totaal. 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 G-standaard, november 2021 Additional remarks Op basis van behandelduur van 12 maanden. 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