Daratumumab Medicine 08 December 2020 Extended indication Smouldering multipel myeloom. Therapeutic value No judgement Total cost € 9,488,224.50 Registration phase Clinical trials Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Smouldering multipel myeloom. 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration April 2022 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in het tweede kwartaal van 2022. 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 NCT03301220. Additional remarks Jaar 1: 23 toedieningen; jaar 2 en 3: 13 toedieningen. Maximale behandelduur van 36 maanden. Expected patient volume per year Patient volume < 111 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies daratumumab. Additional remarks Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.117, waarvan 10% asymptomatisch: 111. Expected cost per patient per year Cost € 61,735.00 - 109,224.00 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: €109.224; Jaar 2 & 3: €61.735. Op basis van de lijstprijs. Potential total cost per year Total cost € 9,488,224.50 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