Province: Québec Indication: rheumatoid arthritis Medication: certolizumab pegol (Cimzia®) Listing Status: Listed—CBC Listing Criteria: Dosage form: S.C. Inj.Sol. syringe, 200 mg/1mL For treatment of moderate or severe rheumatoid arthritis and moderate or severe psoriatic arthritis of rheumatoid type. Upon initiation of treatment or if the person has been receiving the drug for less than five months: the person must, prior to the beginning of treatment, have eight or more joints with active synovitis and one of the following five elements must be present: a positive rheumatoid factor for rheumatoid arthritis only; radiologically measured erosions; a score of more than 1 on the Health Assessment Questionnaire (HAQ); an elevated C-reactive protein level; an elevated sedimentation rate, and the disease must still be active despite treatment with two disease-modifying anti-rheumatic drugs, used either concomitantly or not, for at least three months each. For rheumatoid arthritis, one of the two drugs must be methotrexate at a dose of 20 mg or more per week, unless there is serious intolerance or a contraindication to this dose. For moderate or severe psoriatic arthritis of the rheumatoid type, unless there is serious intolerance or a contraindication, one of the two drugs must be: methotrexate at a dose of 20 mg or more per week; or, sulfasalazine at a dose of 2000 mg per day. The initial request is authorized for a maximum of five months. When requesting continuation of treatment, the physician must provide information making it possible to establish the treatment's beneficial effects, specifically: a decrease of at least 20% in the number of joints with active synovitis and one of the following four elements: a decrease of 20% or more in the C-reactive protein level; a decrease of 20% or more in the sedimentation rate; a decrease of 0.20 in the HAQ score; a return to work. Requests for continuation of treatment are authorized for a maximum period of 12 months. For rheumatoid arthritis, authorizations for certolizumab are given for a dose of 400 mg for the first three doses of the treatment, that is, on weeks 0, 2 and 4, followed by 200 mg every two weeks. For psoriatic arthritis of rheumatoid type, authorizations for certolizumab are given for a dose of 400 mg for the first three doses of the treatment, that is, on weeks 0, 2 and 4, followed by 200 mg every two weeks or 400 mg every four weeks. ® ACE Planning & Consulting Inc.