Mepolizumab Medicine 08 December 2020 Extended indication Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab). Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Mepolizumab Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung other Extended indication Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab). Current proprietary name Already available biosimilars / generics Proprietary name Nucala Manufacturer GSK Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antilichaam gericht tegen IL5; toedieningsvorm is poeder voor oplossing voor injectie (flacon) en oplossing voor injectie (voorgevulde pen) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration September 2021 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 100 mg References NCT04607005 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks