Bimekizumab Medicine 12 June 2018 Extended indication Psoriasis Therapeutic value No judgement Total cost € 6,125,000.00 Registration phase Clinical trials Product Active substance Bimekizumab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Psoriasis Current proprietary name Already available biosimilars / generics Proprietary name 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. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration June 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Brodalumab, Ixekizumab, Secukinumab, Ustekinumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Papp et al. JAM ACAD DERMATOL 2018; 79: 277-286. Additional remarks Expected patient volume per year Patient volume 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er ca. 165.000. Middel zal zijn plek moeten veroveren ten opzichte van andere reeds aanwezige biologicals. Verwachting is een paar honderd patiënten. Aantallen afhankelijk van toekomstig label. 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 Medicijnkosten.nl; Farmacotherapeutisch Kompas Additional remarks Prijs gebaseerd op inschattingen van andere biologicals met dezelfde indicatie (Brodalumab, Ixekizumab, Secukinumab, Ustekinumab). Potential total cost per year Total cost € 6,125,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Psoriatis arthritis; Ankylosing spondylitis References UCB pipeline Additional remarks Other information Additional remarks