Idecabtagene vicleucel Medicine 12 June 2019 Extended indication Multiple Myeloom Relapsed and Refractory Therapeutic value No judgement yet Total cost Registration phase Registration application pending Product Active substance Idecabtagene vicleucel Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Multiple Myeloma Extended indication Multiple Myeloom Relapsed and Refractory Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Celgene Portfolio holder Mechanism of action CAR-T therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CAR-T Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date April 2020 Expected Registration May 2021 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Dit geneesmiddel is geclassificeerd als een ATMP. Fabrikant geeft aan dat indiening in april 2020 heeft plaatsgevonden. Therapeutic value Current treatment options Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 150 - 450 x 10^6 CAR+ T cells References NCT03361748 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Zo'n 1.200 patiënten komen jaarlijks in aanmerking voor een behandeling tegen Multiple Myeloom. Gezien het hier gaat om "Relapsed and Refractory" patiënten zal slechts een deel van deze patiënten in aanmerking komen. Expected cost per patient per year Cost € 320,000.00 - 330,000.00 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 Additional remarks De kosten mogelijk vergelijkbaar met andere CAR-T therapieën tisagenlecleucel en axicabtagene ciloleucel (€320.000 - €330.000). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References AdisInsight Additional remarks Other information Additional remarks