Degarelix Medicine 07 December 2022 Extended indication Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer, for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy and as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Degarelix Domain Oncology Reason of inclusion Generic G Main indication Prostate cancer Extended indication Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer, for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy and as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. Current proprietary name Firmagon (Ferring) Already available biosimilars / generics Geen Proprietary name Manufacturer Accord Healthcare 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. Fabrikant: Accord Healthcare S.L.U Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2022 Expected Registration September 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 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