Imsidolimab Medicine 03 June 2025 Extended indication Imsidolimab monotherapy for treatment of generalised pustular psoriasis in adults and elderly. Therapeutic value No estimate possible yet Total cost € 1,155,000.00 Registration phase Clinical trials Product Active substance Imsidolimab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Imsidolimab monotherapy for treatment of generalised pustular psoriasis in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Vanda Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Spesolimab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De GEMINI-studies lieten goede resultaten zien. De therapeutische waarde ten opzichte van andere behandelopties is nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05352893 (GEMINI1); NCT05366855 (GEMINI2); Expertopinie Additional remarks Expected patient volume per year Patient volume 60 - 80 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Het patiëntvolume wordt geschat op 60 tot 80 patiënten per jaar. 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 Horizonscan Additional remarks De prijs is nog niet bekend. Mogelijk zijn de kosten gelijk aan spesolimab. Potential total cost per year Total cost € 1,155,000.00 Total cost for sluice Additional remarks 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