Bimekizumab Medicine 07 December 2022 Extended indication Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Therapeutic value No estimate possible yet Total cost € 5,018,650.00 Registration phase Registered and reimbursed Product Active substance Bimekizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Current proprietary name Already available biosimilars / generics Proprietary name Bimzelx Manufacturer UCB Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. Vermoedelijk intramurale bekostiging vanwege het feit dat het een biological is. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2022 Expected Registration June 2023 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Dit middel is in de sluis geplaatst tot er een financieel arrangement is overeengekomen. De minister van Volksgezondheid, Welzijn en Sport (VWS) heeft besloten bimekizumab (Bimzelx®) per 2 oktober 2024 te vergoeden uit het basispakket van de zorgverzekering. Het medicijn kan worden gebruikt bij mensen met axiale spondyloartritis. Therapeutic value Current treatment options Verschillende TNF blokkers na falen NSAID of anti-IL17A; secukinumab. 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 Additional remarks Expected patient volume per year Patient volume 300 - 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References ReumaNederland (1); Expert opinie (2); Additional remarks Axiale spondylartritis komt voor bij ongeveer 1 op de 200 mensen. Dit zijn in Nederland ongeveer 95.000 mensen (1). De inschatting is dat ongeveer 8.000 patiënten anti-TNF medicatie kregen in 2021, waarvan 1.000 op interleukine remmers. De verwachting is dat er 300 tot 400 patiënten in aanmerking zullen komen voor bimekizumab (2). Dit aantal zal na verloop van tijd nog hoger kunnen oplopen. Expected cost per patient per year Cost € 14,339.00 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 www.z-index.nl De apothekersinkoopprijs bedraagt €2.206 per verpakking van 2 PFP/PFS (160mg/ml). De apothekersinkoopprijs per injectie bedraagt €1.103. Additional remarks De aanbevolen dosis voor volwassen patiënten met axiale spondylartritis is 160mg (gegeven als 1 subcutane injectie) om de 4 weken. De totale kosten per patiënt zijn dus 13 injecties van €1.103 per injectie = €14.339 (zie draft SmPC) Potential total cost per year Total cost € 5,018,650.00 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