Benralizumab Medicine 03 December 2024 Extended indication Hypereosinofiel syndroom (HES) Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Benralizumab Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other non-oncological hematological medications Extended indication Hypereosinofiel syndroom (HES) Current proprietary name Already available biosimilars / generics Proprietary name Fasenra Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Hypereosinofiel Syndroom (HES) valt onder de eosinofiele bloedziekten. In navolging van de ernstig astma indcaties van Fasenra en Tezspire is dit volgens de afbakeningsbrief 2014 een GVS-traject, aangevuld met een add-on, omdat de behandeling opgestart dient te worden in het ziekenhuis onder begeleiding van een specialist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2025 Expected Registration October 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Mepolizumab, corticosteroïden, immunotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn geen studies gericht op hypereosinofiel syndroom gevonden. Duration of treatment Frequency of administration Dosage per administration References NCT04191304 (NATRON) Additional remarks Expected patient volume per year Patient volume 160 - 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Requena et al. Immun Inflamm Dis. 2021 (1); Hypereosinofiel syndroom. Stichting Zeldzame Bloedziekten. 2024 (2). Additional remarks Met een prevalentie van 0,89 per 100.000 zijn er 160 Nederlanders met hypereosinofiel syndroom (1). Anderzijds wordt er een prevalentie van 250 met circa 35 tot 50 gevallen per jaar in Nederland geschat (2). Expected cost per patient per year Cost References Medicijnkosten.nl (1) Additional remarks Benralizumab injectievloeistof 30mg/ml WWSP 1ml kost €2.537,09 (1). 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