Bimekizumab

Active substance Bimekizumab
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Treatment of plaque psoriasis

Product

Manufacturer UCB
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments 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
Submission date July 2020
Expected Registration August 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Brodalumab, Ixekizumab, Secukinumab, Ustekinumab, adalimumab
Therapeutic value No judgement
Substantiation In de fase 3 studie ten opzichte van adalimumab werd superioriteit van bimekizumab aangetoond. De verwachting is dat de effectiviteit vergelijkbaar zal zijn met de andere IL17-remmers.
Duration of treatment continuous
References Papp et al. JAM ACAD DERMATOL 2018; 79: 277-286.

Expected patient volume per year

Patient volume

350

Market share is generally not included unless otherwise stated.

Additional comments 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
References Medicijnkosten.nl; Farmacotherapeutisch Kompas
Additional comments Prijs gebaseerd op inschattingen van andere biologicals met dezelfde indicatie (Brodalumab, ixekizumab, secukinumab, ustekinumab).

Potential total cost per year

Total cost

6,125,000

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.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Psoriatis arthritis; Ankylosing spondylitis
References UCB pipeline

Other information

There is currently no futher information available.