Omidubicel Medicine 08 December 2020 Extended indication Patients With (Leukemia, Lymphoma, and Myelodysplastic Syndrome (MDS)) who are eligible for allogeneic hematopoietic stem cell transplantation. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Omidubicel Domain Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Patients With (Leukemia, Lymphoma, and Myelodysplastic Syndrome (MDS)) who are eligible for allogeneic hematopoietic stem cell transplantation. Current proprietary name Already available biosimilars / generics Proprietary name NiCord Manufacturer Gamida Cell Ltd 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 Fabrikant Gamida Cell. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2023 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Actual primary completion datum in December 2019. Therapeutic value Current treatment options Op basis van deze studie: https://pubmed.ncbi.nlm.nih.gov/30523748/ is de behandeling feasible. Klein indicatiegebied met ook de opkomst van haplo stamceltransplantatie als donor source. 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 NCT02730299. https://pubmed.ncbi.nlm.nih.gov/30523748/. Additional remarks Expected patient volume per year Patient volume < 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. Er wordt verwacht dat dit geneesmiddel bijna niet in Nederland ingezet zal worden, het zal maximaal in 5% van de gevallen ingezet worden. 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 Yes Indication extensions Aplastic anaemia; Haemoglobinopathies; Myelodysplastic syndromes; Sickle cell anaemia; Thalassaemia. References Adisinsight Additional remarks Fase 1-2 studies. Other information Additional remarks