1 Recommendations

1.1 Bimekizumab is recommended as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non‑radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation (shown by elevated C‑reactive protein or MRI) when non-steroidal anti‑inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated. It is recommended only if:

  • tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and

  • the company provides it according to the commercial arrangement.

1.2 Assess response to bimekizumab after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as:

  • a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units, and

  • a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more.

1.3 Take into account any communication difficulties, or physical, psychological, sensory or learning disabilities that could affect responses to the BASDAI and spinal pain VAS questionnaires, and make any appropriate adjustments.

1.4 If people with the condition and their clinicians consider bimekizumab to be 1 of a range of suitable treatments (including ixekizumab and secukinumab), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.

1.5 This recommendation is not intended to affect treatment with bimekizumab 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 these recommendations were made

Usual treatment for AS and nr‑axSpA is TNF-alpha inhibitors. People may have 1 or more TNF‑alpha inhibitors before being offered secukinumab or ixekizumab. Bimekizumab works in a similar way to these 2 treatments and would be offered to the same population.

Clinical trial evidence shows that bimekizumab is more effective than placebo. Bimekizumab has not been compared directly with secukinumab and ixekizumab. But the results of an indirect comparison suggest that it is as effective as secukinumab and ixekizumab.

A cost comparison suggests bimekizumab has lower costs than ixekizumab but higher costs than secukinumab. Using NICE's cost-comparison methods, bimekizumab only needs to cost less than 1 relevant comparator that is established practice in the NHS, to be recommended as a treatment option. So, bimekizumab is recommended.

For all evidence see the committee papers. To see what NICE did for secukinumab and ixekizumab, see the committee discussion sections in NICE's technology appraisal guidance on secukinumab in nr-axSpA, NICE's technology appraisal guidance on secukinumab in AS and NICE's technology appraisal guidance on ixekizumab.

  • National Institute for Health and Care Excellence (NICE)