Epcoritamab Medicine 04 June 2026 Extended indication 1L Diffuse Large B-Cell Lymphoma (E + R-CHOP) Therapeutic value Total cost € 660,000,000.00 Registration phase Clinical trials Product Active substance Epcoritamab Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication 1L Diffuse Large B-Cell Lymphoma (E + R-CHOP) Current proprietary name Already available biosimilars / generics Proprietary name Tepkinly Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action 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 ATMP Submission date 2028 Expected Registration 2028 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Dit geneesmiddel is in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen. Therapeutic value Current treatment options R-CHOP Therapeutic value Substantiation De eerste interim resultaten worden in 2026 verwacht. Het primaire eindpunt is twee jaar progressievrije overleving in patiënten met IPI 3-5. De verwachting is dat het niet voor alle DLBCL patiënten geïndiceerd wordt. Duration of treatment Frequency of administration Dosage per administration References NCT05578976 (EPCORE DLBCL-2) Additional remarks Expected patient volume per year Patient volume 1,300 - 2,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks Er zijn tussen de 1.300 en 2.000 gebruikers van R-CHOP voor CD20+ DLBCL. Expected cost per patient per year Cost € < 400,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References https://www.formularywatch.com/view/unique-new-lymphoma-treatment-priced-at-37-500-monthly Additional remarks In de Verenigde Staten kost epcoritamab $37,500 per maand. De kosten zullen dus erg afhangen van de behandelduur. Bij een behandeling van zes tot twaalf maanden zal de prijs ongeveer tussen de €200.000 en €400.000 zijn. De prijs in Europa is nog niet bekend. Potential total cost per year Total cost € 660,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks