Product Details

Tremfya

Guselkumab
100 mg/mL
Solution for Subcutaneous Injection
1-mL Single-Dose Pre-filled Syringe (Preservative-Free)

DIN/PIN/NPN

02469758

Manufacturer

Janssen Inc.

Formulary Listing Date

2023-11-30  

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.
 

Requirements


EAP Criteria

 
Therapeutic Class Reimbursement Criteria
Psoriatic Arthritis Treatments

Adalimumab – See Formulary for funded biosimilars

  • Brand(s): Humira (Only for those approved for biosimilar exemption)
  • Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40 mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Certolizumab

  • Brand(s): Cimzia
  • Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – see Formulary for funded biosimilars

  • Brand(s): Enbrel (Only for those approved for biosimilar exemption)
  • Dosage Form/Strength: 25 mg/vial and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options

Golimumab

  • Brand(s): Simponi
  • Dosage Form/Strength: 50 mg/0.5 ml prefilled syringe and autoinjector

Guselkumab

  • Brand(s): Tremfya
  • Dosage Form/Strength: 100 mg/mL prefilled syringe and Patient controlled injector (AI)
  • Effective date: November 27, 2023

Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.

Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).

It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.

Psoriatic Arthritis

Initiation Criteria:

For the treatment of psoriatic arthritis in patients who have:

  • Severe active disease (≥5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months. 

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. 

Duration of Approval of initials: 1 Year 

Renewal will be considered 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, objective evidence of preservation of treatment effect must be provided. 

Duration of Approval of first renewal: 1 Year 

The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: 

  • Adalimumab 40mg every two weeks 

  • Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4 weeks 

  • Etanercept 25 mg twice weekly or 50mg once weekly 

  • Golimumab 50 mg once a month 

  • Secukinumab 100 mg subcutaneously at week 0 and 4, then maintenance dose of 100 mg every 8 weeks thereafter.

Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate). 

Duration of Approval of second and subsequent renewals: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph