Bimekizumab (3) – Bimzelx®

Ankylosing spondylitis

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-949
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) I28627Ankylosing spondylitis, I80914Spondylitis in chronic polyarthritis
Therapeutic area Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease)
Reason for procedure New therapeutic indication
Specialty Bundling ACT change

Therapeutic indication of the resolution

Bimzelx is used for the treatment of adult patients with active ankylosing spondylitis spondylitis (AS) who have had an inadequate response to conventional therapy or who have not tolerated conventional therapy.
Subpopulation Indication Comparator
a) Adults with active ankylosing spondylitis who have responded inadequately to conventional therapy have responded inadequately or have not tolerated conventional therapy A TNF-α inhibitor (Adalimumab or Certolizumab pegol or Etanercept or Golimumab or Infliximab) or an IL-17 inhibitor (Secukinumab or Ixekizumab)
b) Adults with active ankylosing spondylitis who have had an inadequate response to or have not tolerated previous therapy with biological anti-rheumatic drugs (bDMARD) Switching to another biological disease-modifying anti-rheumatic drug: TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or IL-17 inhibitor (secukinumab or ixekizumab)

Studies and Results

No. of studies
(best subpopulation) 		1 (BE MOBILE 2) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: no data submitted)
Reason for dividing into subpopulations (G-BA) Previous treatment
ACT change 23.05.2023 – Neue Leitlinien

  • Clinical trials
    • The BE MOBILE 2 study presented in the dossier is a randomised controlled trial comparing bimekizumab with placebo in the treatment of adult patients with active ankylosing spondylitis.

a) Adults with active ankylosing spondylitis who have responded inadequately to, or are unable to tolerate, conventional therapy

  • For adults with active ankylosing spondylitis who have responded inadequately to, or are unable to tolerate, conventional therapy, the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of bimekizumab compared with the appropriate comparator therapy.
  • Overall assessment
    • An additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.

b) Adults with active ankylosing spondylitis who have responded inadequately to, or are unable to tolerate, prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs)

  • For adults with active ankylosing spondylitis who have responded inadequately to, or are intolerant of, prior treatment with biological anti-rheumatic drugs (bDMARDs), the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of bimekizumab compared with the appropriate comparator therapy.
  • Overall assessment
    • An additional benefit of bimekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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