Daratumumab Medicine 10 December 2019 Extended indication In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. Therapeutic value No estimate possible yet Total cost € 47,771,225.00 Registration phase Registered Product Active substance Daratumumab Domain Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Immunostimulation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antilichaam tegen CD38. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration June 2021 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2021. Op dit moment is er nog geen officieel advies uitgebracht met betrekking tot opname in het basispakket. Therapeutic value Current treatment options Kd, DVd, Pano-Vd, EVd, KRd, ERd, DRd, daratumumab, PomDex. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De data van de gerandomiseerde fase 3 Apollo trial is nog niet beschikbaar. In deze studie wordt Dara-Pom-Dex met Pom-Dex vergeleken. De plaatsbepaling in de richtlijn is hiervan afhankelijk. Duration of treatment Frequency of administration Dosage per administration 16 mg/kg References NCT03180736. Additional remarks Daratumumab in een dosis van 16mg/kg toegediend als een intraveneuze-infusie of 1.800mg subcutaan met wekelijkse intervallen gedurende 8 weken, daarna elke 2 weken gedurende nog eens 16 weken, daarna daarna om de 4 weken. Pomalidomide 4mg oraal (PO) op dag 1 tot en met 21 van elke 28-daagse cyclus Dexamethason 40mg (20mg voor patiënten ≥75 jaar) oraal, eenmaal daags op dag 1, 8, 15 en 22 van elke 28- dag behandelingscyclus. Jaar 1: 23 toedieningen; jaar 2+: 13 toedieningen. Expected patient volume per year Patient volume 300 - 650 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR. Pakketadvies daratumumab (Darzalex®) bij multipel myeloom (ziekte van Kahler), ZIN 2017. Additional remarks In het pakketadvies voor daratumumab wordt het aantal patiënten in de tweede lijn ingeschat op 651 waarvan er 293 patiënten behandeld zullen worden met daratumumab. 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 G-standaard; fabrikant. Additional remarks Jaar 1: 23 toedieningen x €4.372,66 = €100.571,20 Jaar 2+: 13 toedieningen x €4.372,66=€56.844,48. Er is een financieel arrangement van kracht voor Combinatiebehandeling bij multipel myeloom (MM) lopend tot en met 31 december 2024. Potential total cost per year Total cost € 47,771,225.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions 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