Wezlana · DIN 02553317 · 45mg/0.5mL · injection solution-0.5mL Pref Autoinj (Preservative-Free)
Limited Use — Reason for Use code 669, 670, 671, 672 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 669, 670, 671, 672 required
Write on scriptLU code 669, 670, 671, 672 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 669, 670, 671, 672
Reason for Use code 669
For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite:
i) treatment with methotrexate (20mg/week) for at least 3 months; AND
ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.
If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.
Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.
Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.
The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg.
Ustekinumab may be used alone or in combination with methotrexate (MTX).
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 670
For the treatment of severe* plaque psoriasis in patients 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 12 weeks is required.
Patients not responding adequately at 12 weeks should have treatment discontinued.
* 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
-Methotrexate 15-30mg per week
-Acitretin (could have been used with phototherapy)
-Cyclosporine
Maintenance/Renewal:
After 3 months 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
Recommended dose:
The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then 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.
Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg.
For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks.
If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 671
For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria:
A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease);
AND
B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine);
OR
Conventional treatment with a corticosteroid is contraindicated;
AND
C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy.
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg).
The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose.
Maintenance/Renewal:
Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission.
Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.
Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.
Exclusion criteria (initial and renewal coverage):
- Combination therapy with another biologic used to treat inflammatory disease will not be funded.
Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 672
For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria:
A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease);
AND
B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week);
OR
Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate);
OR
Conventional treatment with a corticosteroid is contraindicated;
AND
C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy.
The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg).
The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose.
Maintenance/Renewal:
Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids.
Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy.
Exclusion criteria (initial and renewal coverage):
- Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.
Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.
Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.
Coverage limit:
LU Authorization Period: 1 year
No interchangeable product listed in the Ontario extract
Wezlana · DIN 02553317
Manufacturer: Amgen Canada Inc.; listing date 2025-06-30
Health Canada: Marketed since 2025-02-05 · brand WEZLANA · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Amgen canada inc · schedule Schedule d, Prescription
Wezlana: Formulary list price $2755.8840/unit (unit not stated in source; not the patient's cost)
Ministry pays: $2755.8840 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104226 · Verify on the e-Formulary ↗ (DIN 02553317)
Source record
DIN 02553317: Wezlana
Raw flags: sec12=Y, sec3=Y
Item: 920000794; group id 975; item number 2308; lccId 00388; manufacturer id AMG
Source form: Inj Sol-0.5mL Pref Autoinj (Preservative-Free); strength: 45mg/0.5mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $2755.8840; ministry $2755.8840
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02553317
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104226
Shortage status: not checked (no credentials)