Carmustine Medicine 10 December 2019 Extended indication carmustine with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoieticprogenitor cell transplantation (HPCT) in haematological diseases Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Carmustine Domain Oncology and Hematology Reason of inclusion Generic G Main indication Other hematology Extended indication carmustine with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoieticprogenitor cell transplantation (HPCT) in haematological diseases Current proprietary name Already available biosimilars / generics Proprietary name Carmustine Obvius Manufacturer Oasmia Portfolio holder Mechanism of action Alkylating agent Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks fabrikant Obvius Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date July 2019 Expected Registration 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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