Bimekizumab

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.
Therapeutic value	No estimate possible yet
Total cost	5,018,650.00
Registration phase	Positive CHMP opinion

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

Type of trajectory	Normal trajectory
Submission date	September 2022
Expected Registration	May 2023
Orphan drug	No
Registration phase	Positive CHMP opinion
Additional remarks	Positieve CHMP opinie is verkregen op 26 april 2023. Registratie verwacht vanaf 26 mei 2023.

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 spondyloartritis 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.

Patient volume

300 - 400

Market share is generally not included unless otherwise stated.

References

ReumaNederland (1); Expert opinie (2);

Additional remarks

Axiale spondyloartritis 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 €2206,00 per verpakking van 2 PFP/PFS (160 mg/ml). De AIP per injectie bedraagt €1103,00 euro
Additional remarks	De aanbevolen dosis voor volwassen patiënten met axiale spondyloartritis is 160 mg (gegeven als 1 subcutane injectie) om de 4 weken. De totale kosten per patient zijn dus 13 injecties van €1103,00 per injectie = €14.339,00 (zie draft SmPC)

Cost

14,339.00

References

www.z-index.nl
De AIP bedraagt €2206,00 per verpakking van 2 PFP/PFS (160 mg/ml). 
De AIP per injectie bedraagt €1103,00 euro

Additional remarks

De aanbevolen dosis voor volwassen patiënten met axiale spondyloartritis is 160 mg (gegeven als 1 subcutane injectie) om de 4 weken. 
De totale kosten per patient zijn dus 13 injecties van €1103,00 per injectie = €14.339,00  (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.

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.