Active substance Blinatumomab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication ALL
Extended indication Extension of indication to include the use of blinatumomab as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as consolidation therapy


Proprietary name Blincyto
Manufacturer Amgen
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2020
Expected Registration September 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Standaard consolidatie chemotherapie pediatrische ALL
Therapeutic value No judgement
Substantiation Resultaten worden gepresenteerd tijdens een congres later in 2020.
Duration of treatment Not found
References Fabrikant
Additional comments informatie met betrekking tot effectiviteit, behandelduur, toedieningsfrequentie, dosering nog niet beschikbaar

Expected patient volume per year

Patient volume

< 5

Market share is generally not included unless otherwise stated.

References Fabrikant; expert opinie uit Prinses Maxima Centrum
Additional comments Maximaal 5 patiënten

Expected cost per patient per year

References; Fabrikant
Additional comments €2.791 per blinatumomab infpdr flacon 38,5μg + solv 10 ml. (inclusief BTW). Uiteindelijke kosten nog afhankelijk van dosering en aantal toedieningen.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.