Donor-derived T-lymphocyte enriched leukocyte preparation depleted ex vivo of host-alloreactive T cells. Medicine 09 January 2018 Extended indication Adjunctive treatment to a haploidentical, T-cell depleted haematopoietic stem cell transplantation (HSCT) in adult patients with high-risk haematological malignancies. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Donor-derived T-lymphocyte enriched leukocyte preparation depleted ex vivo of host-alloreactive T cells. Domain Oncology and Hematology Reason of inclusion Main indication Other hematology Extended indication Adjunctive treatment to a haploidentical, T-cell depleted haematopoietic stem cell transplantation (HSCT) in adult patients with high-risk haematological malignancies. 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 New medicine ATMP Unknown Submission date June 2017 Expected Registration January 2019 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Restart of the procedure 27 March 2018 - responses received to Day 120 List of Questions. 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 400-500 allogene stamceltransplantaties per jaar. 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