Benralizumab Medicine 03 December 2024 Extended indication Bulleus pemfigoïd Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Benralizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Bulleus pemfigoïd 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 Deze toediening is in navolging van de ernstig astma indicatie en de afbakeningsbrief 2014 een GVS-traject, aangevuld met een add-on, omdat behandeling in het ziekenhuis opgestart dient te worden onder toezicht van een specialist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration November 2025 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks NCT04612790 (FJORD) is terminated. Therapeutic value Current treatment options Corticosteroïden, azathioprine, mycofenolaat mofetil, methotrexaat, cyclofosfamide, erytromycine, tetracyclines in combinatie met nicotianine. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04612790 (FJORD) Additional remarks n.t.b. Expected patient volume per year Patient volume < 4,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Bulleus pemfigoïd. Orphanet. 2020 (1). Additional remarks De prevalentie in Europa wordt geschat op 1 op de 4.000 (1). 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