Epcoritamab Medicine 07 December 2022 Extended indication Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Epcoritamab Domain Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2022 Expected Registration December 2023 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04628494 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