Daratumumab Medicine 08 December 2020 Extended indication Multipel myeloom frontline behandeling i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT. Therapeutic value No judgement Total cost € 6,648,390.00 Registration phase Clinical trials Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Multipel myeloom frontline behandeling i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT. Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks anti-CD38 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration November 2021 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q4 2021. 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 1800mg References fabrikant, NCT03652064 Additional remarks Jaar 1: 20 toedieningen; jaar 2+: 13 toedieningen Expected patient volume per year Patient volume < 70 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies daratumumab, expert opinie. 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 of <70 met comorbiditeiten, 70% behandeld (352 ptn). 80% van deze groep krijgt Dara-Rd dus max 20% van deze groep krijgt een andere behandeling (< 70 ptn). Expected cost per patient per year Cost € 94,977.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant Additional remarks Jaar 1: €94.977; jaar 2+: €61.735 Potential total cost per year Total cost € 6,648,390.00 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