For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a…
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.