Benralizumab Medicine 12 June 2018 Extended indication Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history. Therapeutic value No estimate possible yet Total cost € 42,625,000.00 Registration phase No registration expected Product Active substance Benralizumab Domain Lung diseases Reason of inclusion Indication extension IND Main indication COPD Extended indication Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history. Current proprietary name Already available biosimilars / generics Proprietary name Fasenra Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks IL-5Rα antagonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Ontwikkeling voor deze indicatie was stopgezet (mei 2018). De RESOLUTE trial heeft de primaire uitkomstmaat niet gehaald. Therapeutic value Current treatment options Mepolizumab en reslizumab zijn concurrerende middelen. Ook omalizumab is geregistreerd voor eenzelfde indicatie, wel heeft dit middel een ander werkingsmechanisme (anti IgE in plaats van anti-IL5). 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 NCT04053634 (RESOLUTE); GOLD aanbevelingen: goldcopd.org Additional remarks Expected patient volume per year Patient volume 500 - 5,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; CBS; NIVEL; Pharmo en Boland DUTCH analyses; Brightling et al. 2014; biologic penetration TNF reuma Additional remarks 17 miljoen inwoners in Nederland, 3,4% heeft COPD. 18% van de COPD patiënten heeft ernstig of zeer ernstig COPD, wat vroeger GOLD 3 en GOLD 4 werd genoemd (LAN Standaard COPD), hiervan heeft 5 tot 15% verhoogde eosinofielen, aanname: biologic penetration van 70% (bij reuma biologics was dit 50%). Expected cost per patient per year Cost € 15,500.00 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 Fabrikant Additional remarks Potential total cost per year Total cost € 42,625,000.00 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