Secukinumab Medicine 07 June 2022 Extended indication Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Therapeutic value Possible added value for a subgroup Total cost € 4,036,800.00 Registration phase Registration application pending Product Active substance Secukinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Current proprietary name Already available biosimilars / generics Proprietary name Cosentyx Manufacturer Novartis Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antilichaam gericht tegen IL-17A. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date February 2022 Expected Registration December 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options NSAID’s , Glucocorticosteroiden, csDMARDS en TNFi (In-label adalimumab en etanercept en off-label golimumab) Therapeutic value Possible added value for a subgroup This assessment does not indicate any potential inclusion in the package. Substantiation Anti-TNF zal waarschijnlijk vooralsnog de eerste keuze blijven. Dit is al gevestigd in de behandelrichtlijn en hier is de meeste ervaring mee in de praktijk. Duration of treatment Frequency of administration 1 times a month Dosage per administration 75 mg per dosering bij kinderen < 50Kg en 150 mg bij kinderen > 50Kg lichaamsgewicht References NCT03769168 Additional remarks Expected patient volume per year Patient volume < 8 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;71:717–34; Mistry RR et al. Open Acc Rheum. 2019;11:19–31; Thierry S et al. Joint Bone Spine (2014) 112-117; Swart et al. Arthritis Res Ther 20, 285 (2018) Additional remarks JIA komt bij ongeveer 4.000 kinderen in Nederland voor; 30-40 nieuwe JIA diagnoses per jaar. De twee subtypen (Psoriatic arthritis en Enthesitis related arthritis) omvatten 20% van alle subtypen. Dit betekent dat er mogelijk substitutie bij een deel van de 800 prevalente patiënten plaats zal vinden plus 6 tot 8 nieuwe patiënten per jaar. Expected cost per patient per year Cost € 336,400.00 - 672,800.00 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 G-standaard Additional remarks Afhankelijk van de dosering (per lichaamsgewicht) betreffen de kosten per patient per jaar € 3364,20 (<50kg) of € 6728,40 (>50kg). De AIP van Cosentyx betreft € 560,70 per 150mg. Potential total cost per year Total cost € 4,036,800.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Hidradenitis Suppurativa References Additional remarks Other information Additional remarks