Lenalidomide Medicine 12 June 2018 Extended indication Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Therapeutic value No judgement Total cost € 45,650,000.00 Registration phase Registered and reimbursed Product Active substance Lenalidomide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Current proprietary name Already available biosimilars / generics Proprietary name Revlimid Manufacturer Celgene Portfolio holder Mechanism of action Immunosuppression Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immuunmodulator/proteasoom inhibitor. IMiD. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2018 Expected Registration May 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Weesgeneesmiddel-status is teruggetrokken. Positieve CHMP-opinie maart 2019. Registratie op 13 mei 2019. Therapeutic value Current treatment options VMP/Rd/VTD/VCD 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 25 mg References NCT00644228; Fabrikant Additional remarks Lenalidomide op dag 1-21 van 28 dagen. Mediane behandelduur afhankelijk of patient een SCT krijgt (dan 6 kuren) of niet (~24kuren) 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. Er worden veel nieuwe behandelmogelijkheden verwacht in 2019, deel van potentiële lenalidomide populatie krijgt al Rd op dit moment. Hoeveel patiënten hiervan daadwerkelijk met LBD zullen worden behandeld moet nog vastgesteld worden. Expected cost per patient per year Cost € 35,000.00 - 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 G-standaard; Fabrikant Additional remarks Dit zijn alleen de kosten voor lenalidomide Potential total cost per year Total cost € 45,650,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References G-standaard Additional remarks Lenalidomide en Velcade hebben off-label add-ons Indication extension Indication extensions Yes Indication extensions lenalidomide+rituximab in rriNHL, en lenalidomide+rituximab+CHOP in ABC DLBCL References Fabrikant Additional remarks Other information Additional remarks