| 512 | 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 50mg per week or 25mg twice weekly. |
| | LU Authorization Period: 1 year |
| 513 | For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with:
- Age of disease onset equal to or younger than 50; AND
- Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND
- Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy.
NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint.
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding 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 50mg per week or 25mg twice weekly. |
| | LU Authorization Period: 1 year |
| 514 | For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented.
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 funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week).
Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. |
| | LU Authorization Period: 1 year |
| 563 | For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% 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 50mg per week or 25mg twice weekly.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. |
| | LU Authorization Period: 1 year |
| 591 | For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.
Claims for the first 6 months must be written by a dermatologist.
Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.
Patients not responding adequately at 12 weeks should have treatment discontinued.
* Definition of severe plaque psoriasis:
Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND
Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND
Dermatology Life Quality Index (DLQI) score of at least 10.
** Definition of failure, intolerance or contraindication to adequate trials of standard therapies:
6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND
12 week trial of phototherapy (unless not accessible), AND
6 month trial of at least 2 systemic, oral agents used alone or in combination
-Methotrexate 15-30mg per week
-Acitretin (could have been used with phototherapy)
-Cyclosporine
Maintenance/Renewal:
After 3 months of therapy, patients who respond to therapy should have:
-At least a 50% reduction in PASI, AND
-at least a 50% reduction in BSA involvement, AND
-at least a 5 point reduction in DLQI score
Approvals will only allow for standard dosing for etanercept:
The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. |
| | LU Authorization Period: 1 year |
