Daratumumab Medicine 10 December 2019 Extended indication Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason Therapeutic value No judgement Total cost € 14,400,000.00 Registration phase Clinical trials Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason 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 July 2020 Expected Registration May 2021 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Bortezomib-cyclofosfamide-dexamethason of lenalidomide-dexamethason. 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 1800 mg References NCT03201965 Additional remarks Daratumumab zal wekelijks worden toegediend in de eerst 8 weken (2 cycli), daarna iedere 2 weken voor 4 cycli (cyclus 3-6) en daarna iedere 4 weken tot progressie of een maximum van 2 jaar. Expected patient volume per year Patient volume < 160 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De behandeling van AL-amyloïdose in Nederland anno 2013, HOVON Additional remarks De incidentie wordt geschat op 8,9 per miljoen persoonjaren; dat betekent dat er in Nederland 160 nieuwe patiënten per jaar zijn. Expected cost per patient per year Cost € 60,000.00 - 120,000.00 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 G-standaard Additional remarks Uitgaande van de behandelduur zoals hierboven beschreven zullen er in het eerste jaar 23 toedieningen worden gegeven en in het tweede jaar 13 toedieningen. De prijs van subcutaan daratumumab, zoals gebruikt in de klinische studie, is nog niet vastgesteld. Waarschijnlijk zal de prijs vergelijkbaar zijn met andere indicaties van daratumumab en inde range van €60.000 tot €120.000 vallen Potential total cost per year Total cost € 14,400,000.00 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 III klinische studies: Relapsed Refractory MM 1+ prior lines w/PomDex; Relapsed Refractory multiple myeloma w/carfilzomib/dex; Amyloidosis; Subcutaneous Formulation in patients with relapsed or refractory multiple myeloma; 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 Pipeline Janssen Additional remarks Other information Additional remarks