Listed in the December 27, 2023 extract; not in the current extract (Aug 26, 2026): Stelara (02320673), Stelara (02320681). Source: odb-formulary-ed43-extract-2023-12-27.xml; compared with odb-formulary-ed43-extract-2026-08-26.xml.
USTEKINUMAB
All injection strengths: Limited Use (codes 668, 669, 670, 671, 672, 733, 742)
Other products in the same Health Canada class (L04A, L04AC) — coverage varies; not interchangeable
- Tocilizumab (Tyenne): limited Use 697, 698, 720, Limited Use 697, 698, 720, 721
- Azathioprine (Imuran): general benefit
- Cyclosporine (Neoral): general benefit
- Leflunomide (Arava): general benefit
- Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
- Mycophenolate (Myfortic): general benefit
15 more in the class list below
Jamteki I.V. · DIN 02553120 · 5mg/mL · injection solution-26mL vial (Preservative-Free)
Limited Use — Reason for Use code 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 671, 672 required
Write on scriptLU code 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 671, 672
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
Jamteki I.V. · DIN 02553120
Manufacturer: Jamp Pharma Corporation; listing date 2025-07-31
Health Canada: Marketed since 2026-05-19 · brand JAMTEKI I.V. · ATC L04AC05 USTEKINUMAB · form Solution · route Intravenous · ingredients USTEKINUMAB 5 MG/ML · company Jamp pharma corporation · schedule Schedule d, Prescription
Jamteki I.V.: Formulary list price $1248.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1248.0000 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=104208 · Verify on the e-Formulary ↗ (DIN 02553120)
Source record
DIN 02553120: Jamteki I.V.
Raw flags: sec12=Y, sec3=Y
Item: 922000012; group id 997; item number 2333; lccId 00412; manufacturer id JPC
Source form: Inj Sol-26mL Vial Pk (Preservative-Free); strength: 5mg/mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1248.0000; ministry $1248.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02553120
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104208
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02553120
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Steqeyma I.V. · DIN 02550261 · 5mg/mL · injection solution-26mL vial (Preservative-Free)
Limited Use — Reason for Use code 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 671, 672 required
Write on scriptLU code 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 671, 672
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
Steqeyma I.V. · DIN 02550261
Manufacturer: Celltrion Healthcare Co. Ltd.; listing date 2024-09-27
Health Canada: Marketed since 2024-08-29 · brand STEQEYMA IV · ATC L04AC05 USTEKINUMAB · form Solution · route Intravenous · ingredients USTEKINUMAB 5 MG/ML · company Celltrion inc. · schedule Schedule d, Prescription
Steqeyma I.V.: Formulary list price $1248.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1248.0000 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=103910 · Verify on the e-Formulary ↗ (DIN 02550261)
Source record
DIN 02550261: Steqeyma I.V.
Raw flags: sec12=Y, sec3=Y
Item: 922000011; group id 996; item number 2332; lccId 00401; manufacturer id CEH
Source form: Inj Sol-26mL Vial Pk (Preservative-Free); strength: 5mg/mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1248.0000; ministry $1248.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02550261
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103910
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02550261
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Otulfi · DIN 02554305 · 5mg/mL · injection solution-vial (Preservative-Free)
Limited Use — Reason for Use code 669, 671, 672, 733 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 669, 671, 672, 733 required
Write on scriptLU code 669, 671, 672, 733 (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, 671, 672, 733
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 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
Reason for Use code 733
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 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.
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
No interchangeable product listed in the Ontario extract
Otulfi · DIN 02554305
Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-11-28
Health Canada: Marketed since 2025-04-16 · brand OTULFI I.V. · ATC L04AC05 USTEKINUMAB · form Solution · route Intravenous · ingredients USTEKINUMAB 5 MG/ML · company Fresenius kabi canada ltd · schedule Schedule d, Prescription
Otulfi: Formulary list price $1248.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1248.0000 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=104317 · Verify on the e-Formulary ↗ (DIN 02554305)
Source record
DIN 02554305: Otulfi
Raw flags: sec12=Y, sec3=Y
Item: 920000801; group id 988; item number 2321; lccId 00420; manufacturer id FKC
Source form: Inj Sol-Vial Pk (Preservative-Free); strength: 5mg/mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1248.0000; ministry $1248.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02554305
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104317
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02554305
Shortage record checked 2026-09-13T08:10:21.292534+00:00
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 2026-09-02
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: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02553317
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamteki · DIN 02543036 · 45mg/0.5mL · injection solution-0.5mL pre-filled syringe Pk
Limited Use — Reason for Use code 668, 669, 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 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 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Jamteki · DIN 02543036
Manufacturer: Jamp Pharma Corporation; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · brand JAMTEKI · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Jamp pharma corporation · schedule Schedule d, Prescription
Jamteki: 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=103153 · Verify on the e-Formulary ↗ (DIN 02543036)
Source record
DIN 02543036: Jamteki
Raw flags: sec12=Y, sec3=Y
Item: 920000780; group id 976; item number 2309; lccId 00387; manufacturer id JPC
Source form: Inj Sol-0.5mL Pref Syr Pk; 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=02543036
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103153
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02543036
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Wezlana · DIN 02544180 · 45mg/0.5mL · injection solution-0.5mL pre-filled syringe Pk
Limited Use — Reason for Use code 669, 670, 671, 672 requiredMarketed · checked 2026-09-02
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 02544180
Manufacturer: Amgen Canada Inc.; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · 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=103271 · Verify on the e-Formulary ↗ (DIN 02544180)
Source record
DIN 02544180: Wezlana
Raw flags: sec12=Y, sec3=Y
Item: 920000782; group id 977; item number 2310; lccId 00388; manufacturer id AMG
Source form: Inj Sol-0.5mL Pref Syr Pk; 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=02544180
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103271
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02544180
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Steqeyma · DIN 02550245 · 45mg/0.5mL · injection solution-0.5mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 668, 669, 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 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 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Steqeyma · DIN 02550245
Manufacturer: Celltrion Healthcare Co. Ltd.; listing date 2024-09-27
Health Canada: Marketed since 2024-08-29 · brand STEQEYMA · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Celltrion inc. · schedule Prescription, Schedule d
Steqeyma: 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=103908 · Verify on the e-Formulary ↗ (DIN 02550245)
Source record
DIN 02550245: Steqeyma
Raw flags: sec12=Y, sec3=Y
Item: 922000009; group id 993; item number 2328; lccId 00399; manufacturer id CEH
Source form: Inj Sol-0.5mL Pref Syr Pk (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=02550245
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103908
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02550245
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Otulfi · DIN 02554283 · 45mg/0.5mL · injection solution-0.5mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 669, 671, 672, 733 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 669, 671, 672, 733 required
Write on scriptLU code 669, 671, 672, 733 (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, 671, 672, 733
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 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
Reason for Use code 733
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 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.
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
No interchangeable product listed in the Ontario extract
Otulfi · DIN 02554283
Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-11-28
Health Canada: Marketed since 2025-04-15 · brand OTULFI · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Fresenius kabi canada ltd · schedule Prescription, Schedule d
Otulfi: 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=104315 · Verify on the e-Formulary ↗ (DIN 02554283)
Source record
DIN 02554283: Otulfi
Raw flags: sec12=Y, sec3=Y
Item: 920000802; group id 978; item number 2311; lccId 00420; manufacturer id FKC
Source form: Inj Sol-0.5mL Pref Syr Pk (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=02554283
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104315
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02554283
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Yesintek · DIN 02562081 · 45mg/0.5mL · injection solution-0.5mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 669, 671, 672, 742 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 669, 671, 672, 742 required
Write on scriptLU code 669, 671, 672, 742 (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, 671, 672, 742
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 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
Reason for Use code 742
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 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.
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
No interchangeable product listed in the Ontario extract
Yesintek · DIN 02562081
Manufacturer: Biosimilar Collaborations Ireland Limited; listing date 2026-05-29
Health Canada: Marketed since 2026-05-21 · brand YESINTEK · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Biocon biologics canada inc · schedule Prescription, Schedule d
Yesintek: 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=106500 · Verify on the e-Formulary ↗ (DIN 02562081)
Source record
DIN 02562081: Yesintek
Raw flags: sec12=Y, sec3=Y
Item: 920000811; group id 979; item number 2312; lccId 00433; manufacturer id BCL
Source form: Inj Sol-0.5mL Pref Syr Pk (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=02562081
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106500
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02562081
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Wezlana · DIN 02544202 · 45mg/0.5mL · injection solution-0.5mL vial
Limited Use — Reason for Use code 669, 670, 671, 672 requiredMarketed · checked 2026-09-02
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 02544202
Manufacturer: Amgen Canada Inc.; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · 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=103273 · Verify on the e-Formulary ↗ (DIN 02544202)
Source record
DIN 02544202: Wezlana
Raw flags: sec12=Y, sec3=Y
Item: 920000784; group id 980; item number 2313; lccId 00388; manufacturer id AMG
Source form: Inj Sol-0.5mL Vial Pk; 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=02544202
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103273
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02544202
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Steqeyma · DIN 02550253 · 90mg/1.0mL · injection solution-1.0mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 668, 669, 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 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 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Steqeyma · DIN 02550253
Manufacturer: Celltrion Healthcare Co. Ltd.; listing date 2024-09-27
Health Canada: Marketed since 2024-08-29 · brand STEQEYMA · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 90 MG/1ML · company Celltrion inc. · schedule Prescription, Schedule d
Steqeyma: 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=103909 · Verify on the e-Formulary ↗ (DIN 02550253)
Source record
DIN 02550253: Steqeyma
Raw flags: sec12=Y, sec3=Y
Item: 922000010; group id 995; item number 2331; lccId 00399; manufacturer id CEH
Source form: Inj Sol-1.0mL Pref Syr Pk (Preservative-Free); strength: 90mg/1.0mL
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=02550253
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103909
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02550253
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Otulfi · DIN 02554291 · 90mg/mL · injection solution-1.0mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 669, 671, 672, 733 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 669, 671, 672, 733 required
Write on scriptLU code 669, 671, 672, 733 (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, 671, 672, 733
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 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
Reason for Use code 733
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 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.
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
No interchangeable product listed in the Ontario extract
Otulfi · DIN 02554291
Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-11-28
Health Canada: Marketed since 2025-04-15 · brand OTULFI · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 90 MG/ML · company Fresenius kabi canada ltd · schedule Schedule d, Prescription
Otulfi: 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=104316 · Verify on the e-Formulary ↗ (DIN 02554291)
Source record
DIN 02554291: Otulfi
Raw flags: sec12=Y, sec3=Y
Item: 920000803; group id 982; item number 2315; lccId 00420; manufacturer id FKC
Source form: Inj Sol-1.0mL Pref Syr Pk (Preservative-Free); strength: 90mg/mL
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=02554291
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104316
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02554291
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Yesintek · DIN 02562103 · 90mg/1.0mL · injection solution-1.0mL pre-filled syringe Pk (Preservative-Free)
Limited Use — Reason for Use code 669, 671, 672, 742 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 669, 671, 672, 742 required
Write on scriptLU code 669, 671, 672, 742 (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, 671, 672, 742
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 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
Reason for Use code 742
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 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.
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
No interchangeable product listed in the Ontario extract
Yesintek · DIN 02562103
Manufacturer: Biosimilar Collaborations Ireland Limited; listing date 2026-05-29
Health Canada: Marketed since 2026-05-21 · brand YESINTEK · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 90 MG/ML · company Biocon biologics canada inc · schedule Schedule d, Prescription
Yesintek: 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=106501 · Verify on the e-Formulary ↗ (DIN 02562103)
Source record
DIN 02562103: Yesintek
Raw flags: sec12=Y, sec3=Y
Item: 920000812; group id 981; item number 2314; lccId 00433; manufacturer id BCL
Source form: Inj Sol-1.0mL Pref Syr Pk (Preservative-Free); strength: 90mg/1.0mL
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=02562103
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106501
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02562103
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Wezlana · DIN 02553309 · 90mg/mL · injection solution-1mL Pref Autoinj (Preservative-Free)
Limited Use — Reason for Use code 669, 670, 671, 672 requiredMarketed · checked 2026-09-02
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 02553309
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 90 MG/1ML · company Amgen canada inc · schedule Prescription, Schedule d
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=104225 · Verify on the e-Formulary ↗ (DIN 02553309)
Source record
DIN 02553309: Wezlana
Raw flags: sec12=Y, sec3=Y
Item: 920000795; group id 983; item number 2316; lccId 00388; manufacturer id AMG
Source form: Inj Sol-1mL Pref Autoinj (Preservative-Free); strength: 90mg/mL
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=02553309
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104225
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02553309
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamteki · DIN 02543044 · 90mg/mL · injection solution-1mL pre-filled syringe Pk
Limited Use — Reason for Use code 668, 669, 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 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 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Jamteki · DIN 02543044
Manufacturer: Jamp Pharma Corporation; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · brand JAMTEKI · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 90 MG/1ML · company Jamp pharma corporation · schedule Prescription, Schedule d
Jamteki: 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=103154 · Verify on the e-Formulary ↗ (DIN 02543044)
Source record
DIN 02543044: Jamteki
Raw flags: sec12=Y, sec3=Y
Item: 920000781; group id 984; item number 2317; lccId 00387; manufacturer id JPC
Source form: Inj Sol-1mL Pref Syr Pk; strength: 90mg/mL
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=02543044
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103154
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02543044
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Wezlana · DIN 02544199 · 90mg/mL · injection solution-1mL pre-filled syringe Pk
Limited Use — Reason for Use code 669, 670, 671, 672 requiredMarketed · checked 2026-09-02
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 02544199
Manufacturer: Amgen Canada Inc.; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · brand WEZLANA · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 90 MG/1ML · company Amgen canada inc · schedule Prescription, Schedule d
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=103272 · Verify on the e-Formulary ↗ (DIN 02544199)
Source record
DIN 02544199: Wezlana
Raw flags: sec12=Y, sec3=Y
Item: 920000783; group id 985; item number 2318; lccId 00388; manufacturer id AMG
Source form: Inj Sol-1mL Pref Syr Pk; strength: 90mg/mL
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=02544199
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103272
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02544199
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Wezlana I.V. · DIN 02544210 · 130mg/26mL · injection solution-26mL vial
Limited Use — Reason for Use code 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 671, 672 required
Write on scriptLU code 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 671, 672
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 I.V. · DIN 02544210
Manufacturer: Amgen Canada Inc.; listing date 2024-04-30
Health Canada: Marketed since 2024-03-01 · brand WEZLANA I.V. · ATC L04AC05 USTEKINUMAB · form Solution · route Intravenous · ingredients USTEKINUMAB 5 MG/ML · company Amgen canada inc · schedule Schedule d, Prescription
Wezlana I.V.: Formulary list price $1248.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1248.0000 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=103274 · Verify on the e-Formulary ↗ (DIN 02544210)
Source record
DIN 02544210: Wezlana I.V.
Raw flags: sec12=Y, sec3=Y
Item: 920000785; group id 986; item number 2319; lccId 00389; manufacturer id AMG
Source form: Inj Sol-26mL Vial Pk; strength: 130mg/26mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1248.0000; ministry $1248.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02544210
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103274
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02544210
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Yesintek I.V. · DIN 02562111 · 130mg/26mL · injection solution-26mL vial (Preservative-Free)
Limited Use — Reason for Use code 671, 672 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 671, 672 required
Write on scriptLU code 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 671, 672
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
Yesintek I.V. · DIN 02562111
Manufacturer: Biosimilar Collaborations Ireland Limited; listing date 2026-05-29
Health Canada: Marketed since 2026-05-21 · brand YESINTEK I.V. · ATC L04AC05 USTEKINUMAB · form Solution · route Intravenous · ingredients USTEKINUMAB 5 MG/ML · company Biocon biologics canada inc · schedule Prescription, Schedule d
Yesintek I.V.: Formulary list price $1248.0000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1248.0000 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=106502 · Verify on the e-Formulary ↗ (DIN 02562111)
Source record
DIN 02562111: Yesintek I.V.
Raw flags: sec12=Y, sec3=Y
Item: 920000813; group id 987; item number 2320; lccId 00432; manufacturer id BCL
Source form: Inj Sol-26mL Vial Pk (Preservative-Free); strength: 130mg/26mL
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1248.0000; ministry $1248.0000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562111
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106502
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02562111
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamteki · PIN 09858364 · 45mg/0.5mL · injection solution-0.5mL vial (Preservative-Free)
Limited Use — Reason for Use code 668, 669, 671, 672 requiredOntario PIN; no Health Canada record under this code
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 671, 672 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
No Health Canada record under this code: Ontario lists it under a product identification number (PIN), not a DIN.
Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
Check Health Canada brand searchPrivate plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Jamteki · DIN 09858364
Manufacturer: Jamp Pharma Corporation; listing date 2025-07-31
No Health Canada record under this code: Ontario lists it under a product identification number (PIN), not a DIN.
Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
Jamteki: 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 · Ontario PIN; see Health Canada brand lookup · Verify on the e-Formulary ↗ (DIN 09858364)
Source record
DIN 09858364: Jamteki
Raw flags: sec12=Y, sec3=Y
Item: 922000013; group id 994; item number 2329; lccId 00387; manufacturer id JPC
Source form: Inj Sol-0.5mL Vial Pk (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=09858364
Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=09858364
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Steqeyma · DIN 02558270 · 45mg/0.5mL · injection solution-0.5mL vial (Preservative-Free)
Limited Use — Reason for Use code 668, 669, 671, 672 requiredApproved · checked 2026-09-02
StatusLimited Use — Reason for Use code 668, 669, 671, 672 required
Write on scriptLU code 668, 669, 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 668, 669, 671, 672
Reason for Use code 668
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 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 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 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
Steqeyma · DIN 02558270
Manufacturer: Celltrion Healthcare Co. Ltd.; listing date 2025-08-29
Health Canada: Approved since 2025-06-04 · brand STEQEYMA · ATC L04AC05 USTEKINUMAB · form Solution · route Subcutaneous · ingredients USTEKINUMAB 45 MG/0.5ML · company Celltrion inc. · schedule Prescription, Schedule d
Steqeyma: 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=106153 · Verify on the e-Formulary ↗ (DIN 02558270)
Source record
DIN 02558270: Steqeyma
Raw flags: sec12=Y, sec3=Y
Item: 922000014; group id 995; item number 2330; lccId 00399; manufacturer id CEH
Source form: Inj Sol-0.5mL Vial Pk (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=02558270
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106153
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02558270
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Approved since 2025-06-04 — choose a marketed DIN from the same-category list.
Other drugs whose Health Canada label lists a similar indication: active psoriatic arthritis, moderately to severely active crohns disease, moderately to severely active ulcerative colitis, psoriasis
From Health Canada product monographs; label wording only, not a treatment recommendation.
Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ.
Covered without a code on the Ontario formulary: ACITRETIN
GUSELKUMAB · Limited Use, codes 658
Psoriatic Arthritis
TREMFYA (guselkumab injection) is indicated for:
• the treatment of adult patients with active psoriatic arthritis.
PM: https://pdf.hres.ca/dpd_pm/00085777.PDF; date 2026-08-14; DIN 02469758; fetched 2026-09-10
Product monograph
(guselkumab injection/guselkumab for injection) is indicated for:
• the treatment of adult patients with moderately to severely active Crohn’s disease.
PM: https://pdf.hres.ca/dpd_pm/00085777.PDF; date 2026-08-14; DIN 02469758; fetched 2026-09-10
Product monograph
(guselkumab injection/guselkumab for injection) is indicated for:
• the treatment of adult patients with moderately to severely active ulcerative colitis.
1.1 Pediatrics
Plaque Psoriasis
• (6 years to 17 years): TREMFYA (guselkumab injection) is indicated for the treatment of
pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who
are candidates for systemic therapy or phototherapy (see 4.1 Dosing Considerations).
PM: https://pdf.hres.ca/dpd_pm/00085777.PDF; date 2026-08-14; DIN 02469758; fetched 2026-09-10
Product monograph
APREMILAST · Off-Formulary Interchangeable, not an ODB benefit
Indications
• Plaque Psoriasis
OTEZLA (apremilast) is indicated for the treatment of adult patients with moderate to
severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
PM: https://pdf.hres.ca/dpd_pm/00084256.PDF; date 2026-04-10; DIN 02434318; fetched 2026-09-10
Product monograph
• Psoriatic Arthritis
OTEZLA (apremilast), alone or in combination with methotrexate, is indicated for the
treatment of active psoriatic arthritis in adult patients who have had an inadequate
response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug
(DMARD).
PM: https://pdf.hres.ca/dpd_pm/00084256.PDF; date 2026-04-10; DIN 02434318; fetched 2026-09-10
Product monograph
RISANKIZUMAB · Limited Use, codes 574
Indications
SKYRIZI (risankizumab injection) is indicated for:
• the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for
systemic therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00085642.PDF; date 2026-07-08; DIN 02519283; fetched 2026-09-10
Product monograph
• the treatment of adult patients with moderately to severely active ulcerative colitis who have had
an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic
treatment, or a Janus kinase (JAK) inhibitor.
PM: https://pdf.hres.ca/dpd_pm/00085642.PDF; date 2026-07-08; DIN 02519283; fetched 2026-09-10
Product monograph
SECUKINUMAB · Limited Use, codes 476
Indications
COSENTYX® (secukinumab injection/secukinumab for injection) is indicated for:
Adult patients
Plaque psoriasis
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who
are candidates for systemic therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10
Product monograph
Psoriatic arthritis
COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis when the
response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10
Product monograph
Hidradenitis Suppurativa
COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis
suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis
suppurativa therapy (see 14.1.5 Hidradenitis suppurativa).
1.1 Pediatrics
Plaque psoriasis
COSENTYX (secukinumab injection/secukinumab for injection) is indicated for the treatment of
moderate to severe plaque psoriasis in patients 6 year and older who are candidates for systemic
therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10
Product monograph
UPADACITINIB · Limited Use, codes 637, 684 (1), Limited Use, codes 684 (2)
RINVOQ (upadacitinib) Page 5 of 108
Unclassified / Non classifié
Ulcerative Colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative
colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of
response to, or intolerance to at least one of conventional, and/or biologic therapy.
PM: https://pdf.hres.ca/dpd_pm/00085368.PDF; date 2026-07-14; DIN 02495155; fetched 2026-09-10
Product monograph
Crohn’s Disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s
disease (CD) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of
response to, or intolerance to at least one of conventional and/or biologic therapy.
PM: https://pdf.hres.ca/dpd_pm/00085368.PDF; date 2026-07-14; DIN 02495155; fetched 2026-09-10
Product monograph
ACITRETIN · General benefit
1 INDICATIONS
SORIATANE (acitretin) is indicated for:
• Severe psoriasis (includes erythrodermic and pustular types)
• Other disorders of keratinization
Severe psoriasis is a condition that involves more than 10% of body surface area or is physically,
occupationally or psychologically disabling.
PM: https://pdf.hres.ca/dpd_pm/00080165.PDF; date APR 04, 2025; DIN 02070847; fetched 2026-09-10
Product monograph
BIMEKIZUMAB · Limited Use, codes 641
Indications
Bimzelx (bimekizumab injection) is indicated for:
• Psoriasis (PsO)
The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for
systemic therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10
Product monograph
• Psoriasis (PsO)
The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for
systemic therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10
Product monograph
CYCLOSPORINE · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (8)
Psoriasis
NEORAL capsules and oral solution (cyclosporine) are indicated for the treatment of severe psoriasis in
patients for whom conventional therapy is ineffective or inappropriate.
PM: https://pdf.hres.ca/dpd_pm/00085584.PDF; date 2026-07-30; DIN 02150662; fetched 2026-09-10
Product monograph
ETANERCEPT · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4)
• treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are
candidates for systemic therapy or phototherapy.
PM: https://pdf.hres.ca/dpd_pm/00083562.PDF; date August 31, 2016; DIN 02455323; fetched 2026-09-10
Product monograph
INFLIXIMAB · Limited Use, codes 468, 469, 470, 471, 477, 478, 479 (2), Limited Use, codes 541, 542, 543, 544, 545, 546, 547 (1), Limited Use, codes 715, 716, 718 (2), Limited Use, codes 592, 593, 594, 595, 596, 597, 598 (1)
• treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates
for systemic therapy. For patients with chronic moderate plaque psoriasis, RemdantryTM should
be used after phototherapy has been shown to be ineffective or inappropriate. When assessing
the severity of psoriasis, the health professional should consider the extent of involvement,
location of lesions, response to previous treatments, and impact of disease on the patient’s
PM: https://pdf.hres.ca/dpd_pm/00081840.PDF; date September 2, 2025; DIN 02419475; fetched 2026-09-10
Product monograph
and 4 more
Coverage source: ON formulary extract 2026-08-26