Viable T-cells Medicine 09 January 2018 Extended indication Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Viable T-cells Domain Oncology and Hematology Reason of inclusion Main indication Haemophilia Extended indication Adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for a malignant disease. Current proprietary name Already available biosimilars / generics Proprietary name ATIR101 Manufacturer Kiadis Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2017 Expected Registration April 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 42 day / days Frequency of administration Dosage per administration 2x10^6 cellen/kg References Clinical trial NCT02500550 Additional remarks Twee intraveneuse infusies van 2x10^6 T-cellen/kg, 42 dagen na elkaar. 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