| 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.
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