Extended indication

Treatment of plaque psoriasis

Therapeutic value

No judgement

Total cost

6,125,000.00

Registration phase

Registration application pending

Product

Active substance

Bimekizumab

Domain

Chronic immune diseases

Reason of inclusion

New medicine (specialité)

Main indication

Skin diseases

Extended indication

Treatment of plaque psoriasis

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

6,125,000.00

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.

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.