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 Possible added value Total cost € 297,060.00 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 Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Er is zeker therapeutische meerwaarde zoals ook bij volwassenen met de diagnose axiale en perifere spondylartritis al is aangetoond. Anti-IL17 therapie wordt bij volwassenen vaak gekozen na TNF-blokker maar ook als eerste keuze biological. In volwassenen is de effectiviteit op sommige domeinen van de ziekte verschillend. Zo is TNF-blokkade met een monoclonaal beter bij colitis of uveitis, maar IL17 is superieur voor de huid en mogelijk beter in remmen van ankylosering bij inflammatie van de wervelkolom. Duration of treatment Frequency of administration Dosage per administration References NCT04527380 (I1F-MC-RHCG); Ramanan et al. ACR Convergence 2024; Expertopinie Additional remarks Expected patient volume per year Patient volume < 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Record Abatacept; ReumaNederland; Ringold S et al. Arthritis Care Res. 2019; Mistry RR et al. Open Acc Rheum. 2019; Thierry S et al. Joint Bone Spine. 2014; Swart et al. Arthritis Res Ther. 2018; GIPdatabank. Additional remarks JIA komt bij ongeveer 4.000 kinderen in Nederland voor; 30 tot 40 nieuwe JIA diagnoses per jaar. De twee subtypen (psoriatic arthritis en enthesitis-related arthritis) omvatten 20% van alle subtypen. Secukinumab is vergelijkbaar bij kinderen. In 2023 waren er ongeveer 30 gebruikers voor JIA-enthesitis en juveniele PsA onder de 18 jaar. 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 per patiënt per jaar voor deze indicatie zal rond dit getal liggen. Potential total cost per year Total cost € 297,060.00 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