Expand all sections

Benralizumab

Fasenra

Extended indication Extension of indication to include treatment of eosinophilic granulomatosis.
Therapeutic value Possible equal value
Total cost 2,610,000.00
Registration phase Registered

Product

Active substance Benralizumab
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Extension of indication to include treatment of eosinophilic granulomatosis.
Proprietary name Fasenra
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks In navolging van de ernstig astma indicatie (het naleven van de afbakeningsbrief), zal dit een GVS-traject worden, aangevuld met een add-on, omdat behandeling opgestart dient te worden onder toezicht van een specialist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration November 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie september 2024.

Therapeutic value

Current treatment options Mepolizumab
Therapeutic value Possible equal value
Substantiation Benralizumab is non-inferieur aan mepolizumab (2).
Frequency of administration 1 times every 4 weeks
Dosage per administration 1 injectie met 30 mg benralizumab
References NCT04157348 (MANDARA) (1); Wechsler et al. NEJM. 2024 (2).

Expected patient volume per year

Patient volume

< 87

Market share is generally not included unless otherwise stated.
References Expertopinie (1). Declaratiedata. 2024 (2).
Additional remarks De incidentie in Nederland is ongeveer 50 nieuwe diagnoses per jaar (1). In de laatste NEJM studie heeft 100% van de geïncludeerde patiënten astma en 70% heeft radiologisch longafwijkingen. In 2023 waren er 87 gebruikers van mepolizumab (2). Het patiëntvolume dat in aanmerking komt voor benralizumab zal afhangen van de prijs ten opzichte van mepolizumab.

Expected cost per patient per year

Cost 30,000.00
References Kosten zijn ongeveer €30.000

Potential total cost per year

Total cost

2,610,000.00

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.
Additional remarks Op basis van de aantallen in de Horizonscan van mepolizumab, is er een range tussen de €1.500.000 en €3.000.000 te verwachten.

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.