Cabazitaxel Medicine 10 December 2019 Extended indication Cabazitaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen. Therapeutic value Possible equal value Total cost Registration phase Positive CHMP opinion Product Active substance Cabazitaxel Domain Oncology and Hematology Reason of inclusion Generic G Main indication Prostate cancer Extended indication Cabazitaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen. Current proprietary name Jevtana (Sanofi-Aventis) Already available biosimilars / generics Proprietary name Cabazitaxel Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Cytostatic Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2019 Expected Registration June 2020 Orphan drug Unknown Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks SPC Jevtana verloopt op 21-03-2026. Positieve CHMP-opinie in april 2020. 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