Extended indication Multiple Myeloom Relapsed and Refractory
Therapeutic value No judgement yet
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
Manufacturer Celgene
Mechanism of action CAR-T therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments CAR-T

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
Submission date April 2020
Expected Registration May 2021
Registration phase Registration application pending
Additional comments Dit geneesmiddel is geclassificeerd als een ATMP. Fabrikant geeft aan dat indiening in april 2020 heeft plaatsgevonden.

Therapeutic value

Therapeutic value No judgement yet
Duration of treatment one-off
Dosage per administration 150 - 450 x 10^6 CAR+ T cells
References NCT03361748

Expected patient volume per year

References NKR
Additional comments 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
Additional comments De kosten mogelijk vergelijkbaar met andere CAR-T therapieën tisagenlecleucel en axicabtagene ciloleucel (€320.000 - €330.000).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References AdisInsight

Other information

There is currently no futher information available.