certolizumab pegol (Cimzia)

following a full submission

certolizumab pegol (Cimzia) is not recommended for use within NHS Scotland.

Licensed indication under review:

- in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying antirheumatic  drugs, including methotrexate, has been inadequate.

- monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

In patients who continued to receive methotrexate despite an incomplete response, the addition of certolizumab pegol produced a rapid and sustained reduction in the signs and symptoms of rheumatoid arthritis, inhibited structural joint damage progression and improved physical function compared with placebo.

However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.