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.
Download detailed advice183KB (PDF)
- Medicine name:
- certolizumab pegol (Cimzia)
- SMC ID:
- For the treatment of adult patients with severe active axial spondyloarthritis.
- Pharmaceutical company
- UCB Pharma Ltd
- BNF chapter
- Musculoskeletal and joint diseases
- Submission type
- Date advice published
- 12 May 2014