Daratumumab Medicine 12 June 2018 Extended indication Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Therapeutic value No estimate possible yet Total cost € 37,780,020.00 Registration phase Registered Product Active substance Daratumumab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Immunostimulation Route of administration Subconjunctival Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antilichaam tegen CD38. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date May 2019 Expected Registration January 2020 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in december 2019. Aanspraak status ZN: nee (mei 2022) Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Cassiopeia trial met primary endpoint Duration of treatment Frequency of administration 1 times a week Dosage per administration 16 mg/kg References NCT02541383; Moreau et al. Lancet. 2019 Jul 6;394(10192):29-38 Additional remarks Tijdens de inductiecycli 1 en 2 is dat eenmaal per week, tijdens cycli 3-6 eenmaal per twee weken. 16 toedieningen in totaal. Expected patient volume per year Patient volume < 540 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 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). Expected cost per patient per year Cost € 69,963.00 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, G-standaard Additional remarks Gelimiteerde behandelduur (inductie en consolidatie) met een vast aantal toedieningen (16 in totaal): €69.963 op basis van lijstprijs. Er is een financieel arrangement van kracht lopend tot en met 31 december 2024. Potential total cost per year Total cost € 37,780,020.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions In fase 3 klinische studies: Relapsed Refractory MM 1+ prior lines w/PomDex; Relapsed Refractory multiple myeloma w/carfilzomib/dex; Amyloidosis; Smoldering multiple myeloma; Frontline multiple myeloma transplant ineligible in combination w/ bortezomib, lenalidomide and dexamethasone; Frontline multiple myeloma transplant eligible in combination w/ bortezomib, lenalidomide and dexamethasone. References Additional remarks Other information Additional remarks