Benralizumab Medicine 04 June 2024 Extended indication Extension of indication to include treatment of eosinophilic granulomatosis. Therapeutic value Possible equal value Total cost € 2,610,000.00 Registration phase Registered Product Active substance Benralizumab Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Extension of indication to include treatment of eosinophilic granulomatosis. Current proprietary name Already available biosimilars / generics Proprietary name Fasenra Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks In navolging van de ernstig astma indicatie (het naleven van de afbakeningsbrief), zal dit een GVS-traject worden, aangevuld met een add-on, omdat behandeling opgestart dient te worden onder toezicht van een specialist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date January 2024 Expected Registration November 2024 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie september 2024. Zorginstituut Nederland heeft de minister voor Medische Zorg geadviseerd om benralizumab (Fasenra®) te vergoeden uit het basispakket van de zorgverzekering op grond van farmaceutische zorg. Therapeutic value Current treatment options Mepolizumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Benralizumab is non-inferieur aan mepolizumab (2). Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1 injectie met 30mg benralizumab References NCT04157348 (MANDARA) (1); Wechsler et al. NEJM. 2024 (2). Additional remarks Expected patient volume per year Patient volume < 87 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie (1). Declaratiedata. 2024 (2). Additional remarks De incidentie in Nederland is ongeveer 50 nieuwe diagnoses per jaar (1). In de laatste NEJM studie heeft 100% van de geïncludeerde patiënten astma en 70% heeft radiologisch longafwijkingen. In 2023 waren er 87 gebruikers van mepolizumab (2). Het patiëntvolume dat in aanmerking komt voor benralizumab zal afhangen van de prijs ten opzichte van mepolizumab. Expected cost per patient per year Cost € 30,000.00 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 Kosten zijn ongeveer €30.000 Additional remarks Potential total cost per year Total cost € 2,610,000.00 Total cost for sluice Additional remarks Op basis van de aantallen in de Horizonscan Geneesmiddelen van mepolizumab, is er een range tussen de €1.500.000 en €3.000.000 te verwachten. 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