Spesolimab Medicine 05 December 2023 Extended indication Spevigo is indicated for the prevention of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy. Therapeutic value No estimate possible yet Total cost € 660,000.00 Registration phase Registration application pending 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 flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy. 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 Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2023 Expected Registration November 2024 Orphan drug No Registration phase Registration application pending 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 Nog in afwachting of het werking heeft bij deze indicatie uitbreiding. In Duitsland is dit middel teruggetrokken vanwege onvoldoende effectiviteit. Duration of treatment Frequency of administration Dosage per administration References Effisayil 2 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 30-50 patiënten hiervoor in aanmerking kan komen maar dat maar 80% van de GPP patiënten kan te maken 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