Lenalidomide / bortezomib / dexamethason Medicine 12 June 2018 Extended indication Multiple myeloom 1e lijn Therapeutic value No judgement Total cost € 56,025,000.00 Registration phase Clinical trials Product Active substance Lenalidomide / bortezomib / dexamethason Domain Oncology and Hematology Reason of inclusion Main indication Multiple Myeloma Extended indication Multiple myeloom 1e lijn Current proprietary name Already available biosimilars / generics Proprietary name Revlimid / Velcade / dexamethason Manufacturer Celgene Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immuunmodulator/proteasoom inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date May 2018 Expected Registration April 2019 Orphan drug Yes 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 Frequency of administration 1 times a day Dosage per administration 15 mg References SWOG; Fabrikant Additional remarks Revlimid op dag 1-21 van 28 dagen. 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 patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. 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 LBD zullen worden behandeld moet nog vastgesteld worden. Expected cost per patient per year Cost € 67,000.00 - 68,000.00 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; Fabrikant Additional remarks €5.196 x 13 = € 67.548 Potential total cost per year Total cost € 56,025,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References G-standaard Additional remarks Revlimid en Velcade hebben off-label add-ons Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks