Benralizumab Medicine 03 December 2024 Extended indication Fasenra is indicated as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause Therapeutic value No estimate possible yet Total cost € 5,986,000.00 Registration phase Positive CHMP opinion Product Active substance Benralizumab Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other non-oncological hematological medications Extended indication Fasenra is indicated as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause Current proprietary name Already available biosimilars / generics Proprietary name Fasenra Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action 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 indicaties 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 ATMP No Submission date August 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2026. 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 1 times every 4 weeks Dosage per administration 30mg 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 € < 29,200.00 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. References Medicijnkosten.nl (1) Additional remarks Benralizumab injectievloeistof 30mg/ml WWSP 1ml kost €2.430,45 (1). Potential total cost per year Total cost € 5,986,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks