Bimekizumab (4) – Bimzelx®

Axial spondyloarthritis, non-radiographic

Characteristics

Start date 01.07.2023 – Marketing authorisation: 05.06.2023
Resolution 21.12.2023
INN Bimekizumab
Brand name Bimzelx®
Pharm. company UCB Pharma GmbH
G-BA Procedure ID D-958
ATC code L04AC21 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) M45.00, M45.01, M45.02, M45.03, M45.04, M45.05, M45.06, M45.07, M45.08, M45.09
Alpha-ID codes (AIS) I117306Non-radiographic axial spondyloarthritis, I80914Spondylitis in chronic polyarthritis
Therapeutic area Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease)
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Bimzelx is used to treat adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as demonstrated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to or are intolerant of non-steroidal anti-inflammatory drugs (NSAIDs).
Subpopulation Indication Comparator
a) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to or are intolerant of non-steroidal anti-inflammatory drugs (NSAIDs) A TNF-α inhibitor (Adalimumab or Certolizumab pegol or Etanercept or Golimumab) or an IL-17 inhibitor (ixekizumab or secukinumab)
b) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response or intolerance to prior therapy with biologic anti-rheumatic drugs (bDMARDs) Switching to another biological disease-modifying anti-rheumatic drug: TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab) or IL-17 inhibitor (ixekizumab or secukinumab)

Studies and Results

No. of studies
(best subpopulation) 		1 (BE MOBILE 1) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: no data submitted)
Reason for dividing into subpopulations (G-BA) Previous treatment

  • Clinical trials
    • The BE MOBILE 1 study presented in the dossier is a randomised controlled trial comparing bimekizumab with placebo in the treatment of adult patients with active non-radiographic axial spondyloarthritis.

a) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to or are intolerant of non-steroidal anti-inflammatory drugs (NSAIDs)

  • For adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or confirmed by magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs) or are unable to tolerate them, the additional benefit is not proven.
  • In accordance with the pharmaceutical manufacturer’s approach set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of a comparison with the appropriate comparator therapy.

b) Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have had an inadequate response to, or have been unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs)

  • For adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to, or are unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs), the additional benefit is not proven.
  • In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of a comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



<< List of all resolutions