certolizumab pegol (Cimzia)

following a full submission

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

Indication under review: in combination with methotrexate, for the treatment of active psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

SMC restriction: Use in patients whose disease has not responded to adequate trials of at least two standard DMARDs either individually or in combination.

In a phase III, randomised, placebo-controlled study in patients with active psoriatic arthritis, significantly more patients who received certolizumab pegol achieved at least 20% response on the American College of Rheumatology criteria (ACR 20) at 12 weeks compared with those who received placebo.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of certolizumab pegol. 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.