Bimekizumab Medicine 07 December 2022 Extended indication Extension of indication to include treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bimekizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Extension of indication to include treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Current proprietary name Already available biosimilars / generics Proprietary name Bimzelx Manufacturer UCB Portfolio holder Incyte 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 Unknown Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2022 Expected Registration July 2023 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 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 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 15,000.00 - 20,000.00 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 Farmacotherapeutisch kompas Additional remarks Bimzelx, 1 ml injectievloeistof 160 mg/ml: € 1.202,27. Op basis van inschattingen van andere biologicals met dezelfde indicatie is de verwachting dat bimekizumab €15.000-€20.000 zal gaan kosten. 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