certolizumab pegol (Cimzia)

following a full submission:

certolizumab pegol (Cimzia®) is accepted for use within NHS Scotland.

Indication under review: Certolizumab pegol is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:

• Ankylosing spondylitis (AS)
  Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
   
• Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA)
  Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and /or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.

In a randomised double-blind study, conducted in axial spondyloarthritis patients, including AS and nr-axSpA patients, there was a significantly higher proportion of Assessment of SpondyloArthritis International Society 20% responders at week 12 for certolizumab pegol- compared to placebo-treated patients.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of certolizumab. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.