Product Details
Siliq
Brodalumab210 mg/1.5 mL
Solution for Injection
1.5-mL Single-Use Prefilled Syringe
DIN/PIN/NPN
02473623
Manufacturer
Valeant Canada Ltd.
Formulary Listing Date
2019-04-30
Unit Price
645.0000
Amount MOH Pays
645.0000
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L04AC12
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
553 | 1 year | For the treatment of severe (see Note 1 below) 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 (see Note 2 below). 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. Approvals will only allow for standard dosing for Siliq 210mg subcutaneously at weeks 0, 1 and 2, and then every 2 weeks. 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. Note 1: 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. Note 2: 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 Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 50% reduction in PASI, AND |