Version 7

Bimekizumab

Medicine

Extended indication Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Therapeutic value Possible equal value
Total cost € 6,125,000.00
Registration phase Registered and reimbursed

Product

Active substance Bimekizumab
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Proprietary name Bimzelx
Manufacturer UCB
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
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 Unknown
Submission date July 2020
Expected Registration August 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie in juni 2021.

Therapeutic value

Current treatment options Brodalumab, Ixekizumab, Secukinumab, Ustekinumab, adalimumab
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.
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.
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 remarks Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er circa 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

Off label use

Off label use No

Indication extension

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

Other information