Ankylosing spondylitis - adalimumab, etanercept and infliximab: review proposal - September 2012

Review of NICE Technology Appraisal Guidance No.143; Adalimumab, etanercept and infliximab for ankylosing spondylitis

In May 2011 TA143; Adalimumab, etanercept and infliximab for ankylosing spondylitis was added to the appraisal static list. 

Additional TNF inhibitors for the treatment of pre-radiographic ankylosing spondylitis (AS) or axial spondyloarthritis (ASpA) have since been considered by Topic Selection but did not continue within the programme as individual single technology appraisals.  As a result, we have decided to re-consider the current static list status of TA143, with direct reference to the additional TNF inhibitors.

There is no new evidence relating to the use of adalimumab, etanercept or infliximab in people with established active ankylosing spondylitis that would be expected to change the existing guidance. However, the TNF inhibitors have been studied at earlier stages of the disease (axial spondyloarthritis), before the radiographic changes required for a diagnosis of ankylosing spondylitis according to the modified New York criteria have occurred. One of the drugs (adalimumab) now has a Committee for Medicinal Products for Human Use (CHMP) positive opinion for use in the treatment of ‘severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis’. 

In response to a previous review proposal on this topic, professional groups indicated that in the light of this new evidence the reference to the modified New York criteria in the guidance was out of date. However at that time none of the TNF-inhibitors had been approved for axial spondyloarthritis.

Consequently, we propose that, subject to referral by the Department of Health, an update of TA143 should take place in the context of a multiple technology appraisal to include:

  • a broadening of the indication to include axial spondyloarthritis without radiographic evidence of ankylosing spondylitis’
  • all TNF-inhibitors that are licensed for the relevant indications or that will be licensed within the timeline of the appraisal.

This expanded remit would encompass an update of TA233 ‘Golimumab for the treatment of ankylosing spondylitis’ which is currently due to be considered for review in August 2014.

In order to be completely confident that this is appropriate, we are asking   consultees and commentators with an interest in this topic, to inform us of any evidence which would suggest that an earlier review would be beneficial.  Please see appendix A for a full list of the organisations we have contacted. 

September 2012

This page was last updated: 19 September 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.