Extended indication Extension of indication to include Bimzelx, alone or in combination with conventional disease-modify
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Bimekizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Extension of indication to include Bimzelx, alone or in combination with conventional disease-modifying antirheumatic drugs (cDMARDs), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more DMARDs.
Proprietary name Bimzelx
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 September 2022
Expected Registration July 2023
Registration phase Registration application pending

Therapeutic value

Current treatment options adalimumab, golimumab, ixekizumab, secukinumab infliximab, certolizumab pegol, etanercept, tofacitinib, ustekinumab, apremilast, abatacept.
Therapeutic value No estimate possible yet
References NCT03895203

Expected patient volume per year

References IQVIA
Additional comments Naar schatting zijn er ongeveer 18.544 mensen in Nederland met psoriatrische artritis die in ziekenhuizen behandeld worden. Hiervan wordt ~26% met een biological behandeld (4.914). Er zijn veel verschillende behandelopties voor deze indicatie.

Expected cost per patient per year

Cost 15,000.00 - 20,000.00
References Farmacotherapeutisch kompas
Additional comments Bimzelx, 1 ml injectievloeistof 160 mg/ml: € 1.202,27. Op basis van inschattingen van andere biologicals met dezelfde indicatie is de verwachting dat bimekizumab €15.000-€20.000 zal gaan kosten.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.