Product Details

Tremfya One-Press

Guselkumab
100 mg/mL
Solution for Injection
1-mL Autoinjector (Preservative-Free)

DIN/PIN/NPN

02487314

Manufacturer

Janssen Inc.

Formulary Listing Date

2024-01-31  

Unit Price

3059.7400

Amount MOH Pays

3059.7400

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AC16

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
658 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**. 

Claims for the first 6 months must be written by a dermatologist. 

Monitoring of patients is required to determine if continuation of therapy beyond 16 weeks is appropriate. Patients not responding adequately at 16 weeks should have treatment discontinued. 

*Definition of severe plaque psoriasis: 

  • Body Surface Area (BSA) involvement of at least 10 percent, 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 16 weeks 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 guselkumab.

The recommended dosing regimen is 100mg administered subcutaneously at week 0 and week 4, followed by maintenance dosing every 8 weeks thereafter, as approved by Health Canada. 

If the patient has not responded adequately after 16 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.
 

EAP Criteria

NO

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