Product Details
Stelara
Ustekinumab90 mg/mL
Solution for Injection
Single-Use Prefilled Syringe Pack
DIN/PIN/NPN
02320681
Manufacturer
Janssen Inc.
Formulary Listing Date
2013-10-31
Unit Price
4593.1400
Amount MOH Pays
4593.1400
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L04AC05
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
419 | 1 year | 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**, but only for patients established on Stelara (ustekinumab) therapy prior to April 30, 2024. *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 Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND 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. |
680 | 12 months from date of authorization | For the treatment of severe plaque psoriasis in patients who meet the following criteria:
|
681 | 12 months from date of authorization | For the treatment of severe plaque psoriasis in patients who meet the following criteria:
|