Daratumumab Medicine 08 December 2020 Extended indication In combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant Therapeutic value No estimate possible yet Total cost € 3,017,130.00 Registration phase Registered and reimbursed Product Active substance Daratumumab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication In combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant 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 No Submission date April 2024 Expected Registration October 2024 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2024. Dit geneesmiddel is niet meer breed uitgesloten: https://zoek.officielebekendmakingen.nl/stcrt-2022-29010.html. Therapeutic value Current treatment options 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 1800mg References Fabrikant, NCT03710603. Additional remarks Eerste jaar: 23 toedieningen Tweede jaar en verder: 13 toedieningen Expected patient volume per year Patient volume < 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, Pakketadvies daratumumab, expert opinie. Additional remarks Jaarlijks aantal nieuwe multipel myeloom patiënten bedraagt 1.333 (NKR 2018), waarvan 90% symptomatisch: 1.200. Ongeveer de helft van deze patiënten komt in aanmerking voor een stamceltransplantatie (n=600). Van deze patiënten wordt in de eerste lijn ongeveer 95% behandeld (n=570). 95% van deze groep krijgt naar verwachting Dara-VTd inductie (542), 5% krijgt een andere behandeling (29 patiënten). Patiëntaantallen zijn neergezet op inschattingen huidige marktsituatie (inschatting = 95% DVTd, 5% andere behandeling). Zodra DVRd beschikbaar komt zal DVRd wel meer dan 5% krijgen in de transplant setting. Expected cost per patient per year Cost € < 100,571.00 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 Eerste jaar: €100.571 Tweede jaar: €56.845. Op basis van lijstprijs. Potential total cost per year Total cost € 3,017,130.00 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