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 judgement Total cost € 34,504,000.00 Registration phase Registered Product Active substance Daratumumab Domain Oncology and 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 Intravenous Therapeutical formulation Intravenous drip 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 Deze daratumumab indicatie valt niet onder het huidige financieel arrangement. Deze indicatie is in de sluis geplaatst aangezien daratumumab breed uitgesloten is van opname in het verzekerde pakket. Positieve CHMP-opinie in december 2019. Therapeutic value Current treatment options Therapeutic value No judgement 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 Daratumumab wordt toegediend in een dosis van 16 mg/kg lichaamsgewicht. 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 < 454 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 fit zijn voor ASCT zijn <70 jaar, 95% behandeld (478 ptn). 95% van deze groep krijgt naar evrwachting Dara-VTd inductie (454 ptn), 5% krijgt een andere behandeling. Expected cost per patient per year Cost € 76,000.00 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 Gelimiteerde behandelduur (inductie en consolidatie) met een vast aantal toedieningen (16 in totaal): €76.000 op basis van lijstprijs. Potential total cost per year Total cost € 34,504,000.00 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