Limited Use Note(s) |
|
TOFACITINIB5mg Tab
| Reason For Use Code | Clinical Criteria |
|---|---|
| 480 | 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.) Maintenance/Renewal: After 12 months of treatment, 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg administered twice daily |
| LU Authorization Period: 1 year | |
| 589 | For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment. The recommended dosing regimen is 5mg twice daily. Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. |
| LU Authorization Period: 1 year |