Spesolimab Medicine 05 December 2023 Extended indication Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Therapeutic value No estimate possible yet Total cost € 660,000.00 Registration phase Registered and reimbursed Product Active substance Spesolimab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Current proprietary name Already available biosimilars / generics Proprietary name Spevigo Manufacturer Boehringer Ingelheim Portfolio holder Boehringer Ingelheim Mechanism of action Antibody-drug conjugate Route of administration Unspecified or multiple Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2023 Expected Registration September 2024 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Geen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit middel heeft een positieve CHMP-opinie en goede resultaten in de Effisayil 2 studie. Er is nog geen ander middel voor deze indicatie en het aantal patiënten is klein. Deze indicatie betreft een preventieve behandeling en is een belangrijke aanvulling van de behandeling voor patiënten met deze ziekte. In Duitsland is dit middel echter eerder teruggetrokken vanwege onvoldoende effectiviteit. Duration of treatment Frequency of administration Dosage per administration The recommended dose of spesolimab is a single dose of 900mg (2 vials of 450mg) administered as an intravenous infusion. If flare symptoms persist an additional 900mg dose may be administered 1 week after the initial dose. References Effisayil 2; Expertopinie Additional remarks Expected patient volume per year Patient volume 30 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Mirza HA, Badri T, Kwan E. Generalized Pustular Psoriasis. [Updated 2020 Sep 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Additional remarks In Frankrijk wordt de prevalentie van Generalized pustular psoriasis geschat op 1,76 per miljoen inwoners. Voor Nederland zou dit neerkomen op ongeveer 30 patiënten. De fabrikant schat in dat in Nederland mogelijk 30 tot 50 patiënten hiervoor in aanmerking kunnen komen. Maar dat maar 80% van de GPP patiënten te maken kan krijgen met GPP flares waarvoor Spesolimab een uitkomst kan bieden. Expected cost per patient per year Cost € > 16,500.00 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 € 660,000.00 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