Ixekizumab (3) – Taltz®

Axial spondyloarthritis

Characteristics

Start date 01.08.2020 – Marketing authorisation: 02.06.2020
Resolution 21.01.2021
INN Ixekizumab
Brand name Taltz®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-569
ATC code L04AC13 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
DDD 2.9 mg P
Therapeutic area Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease)
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Ankylosing spondylitis (radiographic axial spondyloarthritis):

Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

 

Non-radiographic axial spondyloarthritis:

Taltz is indicated for the treatment of adult patients 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 to nonsteroidal anti-inflammatory drugs (NSAIDs).
Subpopulation Indication Comparator
a1) Adult patients with active radiographic axial spondyloarthritis who have had an inadequate response to conventional therapy. A TNF-α inhibitor (etanercept or adalimumab or infliximab or golimumab or certolizumab pegol) or an IL17 inhibitor (secukinumab).
a2) Adult patients with active radiographic axial spondyloarthritis who have had an inadequate response to, or intolerance to, previous biologic antirheumatic drug (bDMARD) therapy. Switching to another biological disease-modifying antirheumatic drug: TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or IL17 inhibitor (secukinumab).
b) Adult patients with active non-radiographic axial spondyloarthritis with objective evidence of inflammation as demonstrated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). A TNF-α inhibitor (etanercept or adalimumab or golimumab or certolizumab pegol)

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted
Reason for dividing into subpopulations (G-BA) Previous treatment, Gene/mutation specifics

  • Clinical trials
    • The COAST-V study is a double-blind, randomised, controlled, multicentre study.
    • The COAST-W trial is a double-blind, randomised, controlled, multicentre trial.
    • The COAST-X trial is a double-blind, randomised, controlled, multicentre trial.

a1) Adult patients with active radiographic axial spondyloarthritis who have responded inadequately to conventional therapy

  • For adult patients with active radiographic axial spondyloarthritis who have responded inadequately to conventional therapy, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
  • In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer has not provided any suitable direct comparative studies against the appropriate comparator therapy.
  • Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
  • Overall, for adult patients with active radiographic axSpA who have responded inadequately to conventional therapy, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

a2) Adult patients with active radiographic axial spondyloarthritis who have responded inadequately to prior treatment with biological disease-modifying anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment

  • For adult patients with active radiographic axial spondyloarthritis who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
  • In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
  • Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
  • Overall, for adult patients with active radiographic axSpA who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

b) Adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as evidenced by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs)

  • For 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 responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
  • In its dossier for the assessment of the additional benefit of ixekizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
  • Furthermore, no indirect comparisons were presented to address the benefit assessment question.
  • Overall, for adult patients with active non-radiographic axSpA with objective signs of inflammation, as demonstrated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to non-non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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