Ixekizumab Medicine 03 December 2024 Extended indication Ixekizumab monotherapy for treatment of active enthesitis-related or psoriatic juvenile idiopathic arthritis in children and adolescents Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ixekizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Ixekizumab monotherapy for treatment of active enthesitis-related or psoriatic juvenile idiopathic arthritis in children and adolescents Current proprietary name Already available biosimilars / generics Proprietary name Taltz Manufacturer Eli Lilly Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection 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 August 2024 Expected Registration June 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. Therapeutic value Current treatment options NSAIDs, glucocorticosteroiden, csDMARDS en TNFi (In-label adalimumab en etanercept en off-label golimumab) 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 NCT04527380 (I1F-MC-RHCG) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 9,902.00 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 GIPdatabank (1) Additional remarks In 2021 was de vergoeding per gebruiker van Taltz €9.902,61 (1). De verwachte kosten p.p.p.j. voor deze indicatie zal rond dit getal liggen. Potential total cost per year Total cost 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