Sarilumab Medicine 08 June 2021 Extended indication Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX. Therapeutic value Possible equal value Total cost € 4,528,800.00 Registration phase Registered and reimbursed Product Active substance Sarilumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX. Current proprietary name Already available biosimilars / generics Proprietary name Kevzara Manufacturer Sanofi 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 December 2023 Expected Registration January 2025 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Adalimumab, etanercept, tocilizumab, abatacept Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog geen data gepubliceerd. Anti-TNF zal vooralsnog eerste keuze bij pJIA blijven. Het geneesmiddel zal naar verwachting een vergelijkbare effectiviteit hebben als tocilizumab. Het werkingsmechanisme is namelijk ook vergelijkbaar met tocilizumab. Duration of treatment Frequency of administration Dosage per administration References NCT02776735 Additional remarks Expected patient volume per year Patient volume < 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Reumanederland (1); Declaratiedata (2). Additional remarks Juvenile idiopathic arthritis komt voor bij ongeveer 4.000 kinderen in Nederland met ongeveer 30 tot 40 nieuwe gevallen per jaar (1). Het aandeel polyartritis van de totale JIA groep is in totaal 25%. Er zijn 332 patiënten die op dit moment interleukine remmers ontvangen voor deze indicatie (2). Expected cost per patient per year Cost € 11,322.00 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 Lijstprijs voor een jaar behandelen op basis van de G-Standaard van Z-Index. Additional remarks Huidige kosten per dag inclusief btw: €35,69 voor de sterkte 175mg/ml pen 1,14ml (€32,74 exclusief btw). Kosten op jaarbasis in 2019 per patiënt betrof €7.353 (op basis van de GIP databank waarbij waarschijnlijk geen volledig jaar is behandeld voor de gehele populatie en de kosten lager uitvallen). Potential total cost per year Total cost € 4,528,800.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks