Province: Québec
Indication: rheumatoid arthritis
Medication: tofacitinib (Xeljanz®)
Listing Status: Listed—CBC
Listing Criteria:
Dosage form:
tablet, 5mg, 11mg
In association with methotrexate, for treatment of moderate or severe rheumatoid arthritis, unless there is a serious intolerance or contraindication to methotrexate.
- Upon initiation of treatment or if the person has been receiving the drug for less than five months:
- prior to the beginning of treatment, the person must have eight or more joints with active synovitis and one of the following five elements must be present:
- a positive rheumatoid factor;
- 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. Unless there is serious intolerance or a serious contraindication, one of the two drugs must be methotrexate at a dose of 20 mg or more per week unless there is a serious intolerance or a contraindication to this dose.
- The initial request is authorized for a maximum of five months.
- When requesting continuation of treatment, the physician must provide
- 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 period of 12 months.
- prior to the beginning of treatment, the person must have eight or more joints with active synovitis and one of the following five elements must be present:
CDR Recommendation:
The Canadian Drug Expert Committee (CDEC) recommends that tofacitinib be listed, in combination with methotrexate (MTX), for reducing the signs and symptoms of rheumatoid arthritis, in adults with moderately to severely active rheumatoid arthritis or as monotherapy in those who were intolerant to MTX, if the following clinical criterion and conditions are met:
Clinical criterion:
- Inadequate response or intolerance to non-biologic disease-modifying antirheumatic drugs (DMARDs).
- List in similar manner to biologic DMARDs
- Daily dosage not to exceed 10mg (i.e., 5 mg twice daily)
- Drug plan cost for tofacitinib not to exceed the drug plan costs for the biologic DMARDs reimbursed.