Degarelix Medicine 07 December 2022 Extended indication Vergevorderd hormoonafhankelijk prostaatcarcinoom; Hoog-risico gelokaliseerd of lokaal gevorderd hormoonafhankelijk prostaatcarcinoom: in combinatie met radiotherapie of als neo-adjuvante behandeling voorafgaand aan radiotherapie. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Degarelix Domain Oncology Reason of inclusion Generic G Main indication Prostate cancer Extended indication Vergevorderd hormoonafhankelijk prostaatcarcinoom; Hoog-risico gelokaliseerd of lokaal gevorderd hormoonafhankelijk prostaatcarcinoom: in combinatie met radiotherapie of als neo-adjuvante behandeling voorafgaand aan radiotherapie. Current proprietary name Firmagon (Ferring) Already available biosimilars / generics Geen Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme.gonadotrophin releasing hormone (GnRH) antagonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2022 Expected Registration September 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPC Firmagon verloopt per 12 april 2023. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References 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 References Additional remarks 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