Carfilzomib Medicine 12 June 2018 Extended indication Newly diagnosed multiple myeloma (MM) - in combination with lenalidomide and dexamethasone. Therapeutic value No judgement Total cost € 62,250,000.00 Registration phase Clinical trials Product Active substance Carfilzomib Domain Oncology and Hematology Reason of inclusion Main indication Multiple Myeloma Extended indication Newly diagnosed multiple myeloma (MM) - in combination with lenalidomide and dexamethasone. Current proprietary name Already available biosimilars / generics Proprietary name Kyprolis Manufacturer Amgen Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Selective and irreversible proteasome inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 88 week / weeks Frequency of administration 6 times a month Dosage per administration 20-27 mg/m2 References Siegel et al. J Clin Oncol JCO2017765032. 2018 Jan 17. Additional remarks 20mg/m2 op dagen 1 en 2 van de eerste cycle, dagen 8, 9, 15 en 16: 27 mg/m2. De daarop volgende cycles dagen 1,2,8,9,15,16 27 mg/m2 (cycles van 4 weken). Expected patient volume per year Patient volume < 830 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 1117, waarvan 90% symptomatisch: 1006. Patiënten <70 jaar zonder co-morbiditeiten bedraagt 50%. 95% wordt behandeld (478). Patiënten >70 jaar en >65 met co-morbiditeiten bedraagt 50%. 70% wordt behandeld (352). In totaal worden er dus jaarlijks 478+352=830 patiënten in de eerste lijn behandeld. Hoeveel patiënten hiervan daadwerkelijk met Carfilzomib zullen worden behandeld moet nog vastgesteld worden. Expected cost per patient per year Cost € 75,000.00 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 Inschatting op basis van kosten carfilzomib 10 mg van €212 en behandelschema studie ASPIRE. Uitgaande van een volledig behandeljaar. Potential total cost per year Total cost € 62,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks