BIMZELX (bimekizumab) - Axial spondyloarthritis

Opinions on drugs - Posted on Apr 29 2024

Reason for request

Indication extension

Key points

Approval of reimbursement for: “Treatment of active non-radiographic axial spondyloarthritis, associated with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), in adults who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs)”.

“Treatment of active axial spondyloarthritis in adults who have responded inadequately or are intolerant to conventional therapy”.

Clinical Benefit

Low	The Committee deems that the clinical benefit of BIMZELX (bimekizumab) 160 mg solution for injection in pre-filled syringe and pre-filled pen is low in the marketing authorisation indication.

Clinical Added Value

no clinical added value

In view of:

the evidence of superiority versus placebo;
but the lack of robust comparison to a clinically relevant comparator despite being feasible;

the Committee deems that BIMZELX (bimekizumab) provides no clinical added value (CAV V) in the current therapeutic strategy which includes the relevant comparators.