Tabelecleucel Medicine 12 June 2019 Extended indication Treatment of patients with Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorder in the allogeneic hematopoietic cell transplant setting who have failed on rituximab. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tabelecleucel Domain Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Treatment of patients with Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorder in the allogeneic hematopoietic cell transplant setting who have failed on rituximab. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Atara Portfolio holder Mechanism of action Allogeneic modified cell therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Yes Submission date October 2021 Expected Registration July 2022 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 3 times every 5 weeks Dosage per administration References klinische studies: ALLELE en MATCH. Additional remarks Tabelecleucel wordt toegediend in cycli van 5 weken (35 dagen). Gedurende elke cyclus zal tabelecleucel worden toegediend in een dosis van 2×10^6 cellen/kg op dagen 1, 8 en 15. Indien nodig worden meerdere behandelcycli gevolgd. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Op basis van de declaratiegegevens voor rituximab bij de indicatie: Behandeling van post-transplantatie lymfoproliferatieve ziekte (PTLD) na orgaan- of stamcel transplantatie bij volwassenen, is de inschatting dat er zo'n 30-50 patiënten rituxmab krijgen bij PTLD. Gezien rituximab echter relatief goed werkt voor deze groep patiënten is de verwachting dat slechts een deel hiervan in aanmerking zal komen voor tabelecleucel. 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 No Indication extensions References www.clinicaltrials.gov. Additional remarks Other information Additional remarks