Daratumumab Medicine 12 June 2018 Extended indication Multipel myeloom frontline behandeling in combinatie met Rd, non fit voor ASCT. Therapeutic value No judgement Total cost € 17,190,000.00 Registration phase Clinical trials Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Main indication Multiple Myeloma Extended indication Multipel myeloom frontline behandeling in combinatie met Rd, non fit voor ASCT. Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Unknown 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 Unknown Particularity Indication extension ATMP Unknown Submission date January 2019 Expected Registration November 2019 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Daratumumab zit in de sluisprocedure. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 16 mg/kg References NCT02252172 Additional remarks Once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity. Expected patient volume per year Patient volume < 191 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 nieuwe MM patienten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar en >65 met comorbiditeiten (50%; 478 patiënten). Hiervan zal naar verwachting 40% een behandeling met Rd krijgen, dit betekent dat 191 patiënten in aanmerking komen. Hoeveel patiënten hiervan daadwerkelijk ook met Daratumumab zullen worden behandeld moet nog vastgesteld worden. Expected cost per patient per year Cost € 90,000.00 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 Medicijnkosten.nl Additional remarks Flacon 100 mg kost €483,36. Totaal is gebaseerd op een patient van 70 kg en een behandeling van 6 maanden. Potential total cost per year Total cost € 17,190,000.00 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 References Additional remarks Other information Additional remarks