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    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Ixekizumab is not recommended, within its marketing authorisation, for treating:

  • active ankylosing spondylitis that has responded inadequately to conventional therapy in adults, or

  • active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI, or both) that has responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs) in adults.

1.2 This recommendation is not intended to affect treatment with ixekizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Ixekizumab would be offered when people cannot have tumour necrosis factor (TNF)-alpha inhibitors or they have not worked well enough. The current treatment option in these situations is conventional therapy, which includes nonsteroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. Secukinumab is also an option for treating radiographic disease but there is not enough data to reliably compare it with ixekizumab.

Clinical evidence from the COAST trials shows that ixekizumab is effective compared with placebo. However, the company's estimates of cost effectiveness for ixekizumab compared with conventional therapy were above the level usually considered cost effective. They were also uncertain because they were not based on the best available evidence. Therefore, ixekizumab is not recommended.