Extended indication Adults with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (
Therapeutic value Possible added value
Total cost 2,625,000.00
Registration phase Registration application pending

Product

Active substance Blinatumomab
Domain Oncology and Hematology
Main indication Leukemia
Extended indication Adults with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Proprietary name Blincyto
Manufacturer Amgen
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Expected Registration August 2018
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Diverse chemo-schema's
Therapeutic value Possible added value
Dosage per administration 15 μg/m2
References Gökbuget et al. ASH 2014; Abstract 379 and oral presentation.
Additional remarks Fabrikant: Behandelduur is max. 4 cycli indien response. Cyclus: 4 weken continue infusie (cIV) daarna behandelingsvrij interval van 2 weken.

Expected patient volume per year

Patient volume

20 - 30

Market share is generally not included unless otherwise stated.

References Fabrikant
Additional remarks NKR: b-ALL in totaal 165 patiënten, hiervan hebben 40 patiënten b-ALL met cytogenetische afwijkingen. Inschatting fabrikant 20-30.

Expected cost per patient per year

Cost 70,000.00 - 140,000.00
References Medicijnkosten.nl; Fabrikant
Additional remarks €2.912,21 per blinatumomab infpdr flacon 38,5 μg + solv 10 ml (uitgaande van 1,7m2). €55.331,99 per cyclus. Fabrikant (nov 2017): Behandelduur van 1-2 cycli (28 behandeldagen, 28 μg/dag). Uitgaande van 1 behandeling per patiënt jaar: €70.000-140.000 pppj.

Potential total cost per year

Total cost

2,625,000.00

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.

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.