| 419 | For the treatment of severe* plaque psoriasis in patients 18 years of age or older 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 Stelara 45mg to be administered at weeks 0, 4 and every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. If the patient has not responded after 12 weeks of treatment, the physician should consider switching to an alternative biologic agent.
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