BL-8040 Medicine 12 June 2019 Extended indication Bone marrow transplant in MM icm G-CSF. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance BL-8040 Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Bone marrow transplant in MM icm G-CSF. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BioLineRx Portfolio holder Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Weesgeneesmiddelstatus van de FDA voor stamcel mobilisatie. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 1.25mg/kg + G-CSF References NCT03246529 Additional remarks GENESIS: Tot 2 subcutane injecties van BL-8040 worden verwacht tijdens de studie Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies daratumumab (Darzalex®) bij multipel myeloom, ZIN 2017 Additional remarks Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar en >65 met comorbiditeiten (50%). Dit betekent dat van de maximaal 500 patiënten een deel hiervan in aanmerking zal komen voor deze nieuwe behandeling. 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 PhII: Acute myeloid leukaemia; Pancreatic cancer References Additional remarks Other information Additional remarks