Product Details
Tremfya
Guselkumab200 mg/2 mL (100 mg/mL)
Solution for Subcutaneous Injection
2-mL Single-Dose Pre-filled Pen (Preservative-Free)
DIN/PIN/NPN
02559145
Manufacturer
Janssen Inc.
Formulary Listing Date
2026-04-16
Unit Price
3059.7400
Amount MOH Pays
3059.7400
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L04AC16
Interchangeable Products
NOLU Clinical Criteria
NORequirements
EAP Criteria
| Therapeutic Class | Reimbursement Criteria |
|---|---|
| Psoriatic Arthritis Treatments | Adalimumab – See Formulary for funded biosimilars
Certolizumab
Etanercept – see Formulary for funded biosimilars
Golimumab
Guselkumab
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:
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:
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: |