Limited Use Note(s) |
|
UPADACITINIB15mg ER Tab
| Reason For Use Code | Clinical Criteria |
|---|---|
| 637 | 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 treatment with other disease modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: i) Methotrexate (i.e. 20mg/week for at least 3 months) ii) Methotrexate (20mg/week) for at least 3 months AND leflunomide (20mg/day) for at least 3 months iii) Methotrexate 20mg/week, sulfasalazine (2g/day) AND hydroxychloroquine (dose based on weight up to 400mg per day) for at least 3 months. In patients who demonstrated initial response to treatment (defined as an achievement of an American College of Rheumatology [ACR] improvement criteria of at least 20% [ACR20] at week 12), ongoing maintenance therapy is funded. Maintenance/Renewal: After 12 weeks of treatment, maintenance therapy is funded for patients who achieved an American College of Rheumatology (ACR) improvement criteria of at least 20% (ACR20) and a minimum of improvement in 2 swollen joints by week 12. For renewals beyond 12 months, 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 15mg administered once daily. Upadacitinib shoud not be used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's RA. |
| LU Authorization Period: 1 year | |
| 684 | 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. 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 upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. |
| LU Authorization Period: 1 year |