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Bimekizumab

Bimzelx

Extended indication Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthriti
Therapeutic value No estimate possible yet
Total cost 5,018,650.00
Registration phase Registered

Product

Active substance Bimekizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional 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
ATMP No
Submission date September 2022
Expected Registration June 2023
Orphan drug No
Registration phase Registered
Additional remarks Dit middel is in de sluis geplaatst tot er een financieel arrangement is overeengekomen. Zorginstituut Nederland beoordeelt of bimekizumab (Bimzelx®) vergoed kan worden. Start beoordeling dossier in april 2023. Datum publicatie advies is nog niet bekend.

Therapeutic value

Current treatment options Verschillende TNF blokkers na falen NSAID of anti-IL17A; secukinumab.
Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

300 - 400

Market share is generally not included unless otherwise stated.
References ReumaNederland (1); Expert opinie (2);
Additional remarks Axiale spondylartritis komt voor bij ongeveer 1 op de 200 mensen. Dit zijn in Nederland ongeveer 95.000 mensen (1). De inschatting is dat ongeveer 8.000 patiënten anti-TNF medicatie kregen in 2021, waarvan 1.000 op interleukineremmers. De verwachting is dat er 300 tot 400 patiënten in aanmerking zullen komen voor bimekizumab (2). Dit aantal zal na verloop van tijd nog hoger kunnen oplopen.

Expected cost per patient per year

Cost 14,339.00
References www.z-index.nl De AIP bedraagt €2.206 per verpakking van 2 PFP/PFS (160mg/ml). De AIP per injectie bedraagt €1.103
Additional remarks De aanbevolen dosis voor volwassen patiënten met axiale spondylartritis is 160mg (gegeven als 1 subcutane injectie) om de 4 weken. De totale kosten per patiënt zijn dus 13 injecties van €1.103 per injectie = €14.339 (zie draft SmPC)

Potential total cost per year

Total cost

5,018,650.00

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

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.