Mepolizumab

Extended indication	Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab).
Therapeutic value	No judgement
Registration phase	Registration application pending

Product

Active substance	Mepolizumab
Domain	Lung diseases
Reason of inclusion	Indication extension
Main indication	Lung other
Extended indication	Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab).
Proprietary name	Nucala
Manufacturer	GSK
Mechanism of action	Interleukin inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)
Additional remarks	Monoklonaal antilichaam gericht tegen IL5; toedieningsvorm is poeder voor oplossing voor injectie (flacon) en oplossing voor injectie (voorgevulde pen)

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

Current treatment options	Meestal wordt bij behandeling van CRSwNP volstaan met INC. Een gedeelte wordt geopereerd en als dat niet helpt kunnen biologicals worden ingezet. Dupilumab is sinds kort beschikbaar.
Therapeutic value	No judgement
Frequency of administration	1 times every 4 weeks
Dosage per administration	100 mg
References	NCT04607005

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.