TOFACITINIB
All products: Limited Use (codes 480, 589, 743)
Other products in the same Health Canada class (L04A, L04AF) — coverage varies; not interchangeable
- Upadacitinib (Rinvoq): limited Use 637, 684, Limited Use 684
- Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634
- Etanercept (Erelzi): limited Use 498, 499, 514, 563, 591, Limited Use 512, 513, 514, 563, 591
- Infliximab (Remdantry): limited Use 468, 469, 470, 471, 477, 478, 479, Limited Use 541, 542, 543, 544, 545, 546, 547, Limited Use 592, 593, 594, 595, 596, 597, 598, Limited Use 715, 716, 718
- Tocilizumab (Tyenne): limited Use 697, 698, 720, Limited Use 697, 698, 720, 721
- Apremilast (Otezla): not a benefit
Auro-Tofacitinib · DIN 02530007 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Auro-Tofacitinib · DIN 02530007
Manufacturer: Auro Pharma Inc.; listing date 2023-01-31
Health Canada: Marketed since 2022-11-28 · brand AURO-TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Auro pharma inc · schedule Prescription
Auro-Tofacitinib: Formulary list price $5.9897/unit (unit not stated in source; not the patient's cost)
Ministry pays: $5.9897 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=101923 · Verify on the e-Formulary ↗ (DIN 02530007)
Source record
DIN 02530007: Auro-Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id AUR
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $5.9897; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02530007
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101923
Interchangeable products
Jamp Tofacitinib · DIN 02522896 · $5.9897
PMS-Tofacitinib · DIN 02522799 · $5.9897
Sandoz Tofacitinib · DIN 02551691 · $5.9897
Taro-Tofacitinib · DIN 02511304 · $5.9897
Xeljanz · DIN 02423898 · $5.9897
Shortage status: resolved shortage (ended 2024-08-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02530007
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Tofacitinib · DIN 02522896 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Jamp Tofacitinib · DIN 02522896
Manufacturer: Jamp Pharma Corporation; listing date 2023-11-30
Health Canada: Marketed since 2023-10-20 · brand JAMP TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Jamp pharma corporation · schedule Prescription
Jamp Tofacitinib: Formulary list price $5.9897/unit (unit not stated in source; not the patient's cost)
Ministry pays: $5.9897 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=101198 · Verify on the e-Formulary ↗ (DIN 02522896)
Source record
DIN 02522896: Jamp Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id JPC
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $5.9897; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02522896
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101198
Interchangeable products
Auro-Tofacitinib · DIN 02530007 · $5.9897
PMS-Tofacitinib · DIN 02522799 · $5.9897
Sandoz Tofacitinib · DIN 02551691 · $5.9897
Taro-Tofacitinib · DIN 02511304 · $5.9897
Xeljanz · DIN 02423898 · $5.9897
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=02522896
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Tofacitinib · DIN 02522799 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
PMS-Tofacitinib · DIN 02522799
Manufacturer: Pharmascience Inc.; listing date 2023-01-31
Health Canada: Marketed since 2022-11-25 · brand PMS-TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Pharmascience inc · schedule Prescription
PMS-Tofacitinib: Formulary list price $5.9897/unit (unit not stated in source; not the patient's cost)
Ministry pays: $5.9897 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=101191 · Verify on the e-Formulary ↗ (DIN 02522799)
Source record
DIN 02522799: PMS-Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id PMS
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $5.9897; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02522799
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101191
Interchangeable products
Auro-Tofacitinib · DIN 02530007 · $5.9897
Jamp Tofacitinib · DIN 02522896 · $5.9897
Sandoz Tofacitinib · DIN 02551691 · $5.9897
Taro-Tofacitinib · DIN 02511304 · $5.9897
Xeljanz · DIN 02423898 · $5.9897
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=02522799
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Tofacitinib · DIN 02551691 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Sandoz Tofacitinib · DIN 02551691
Manufacturer: Sandoz Canada Inc.; listing date 2025-09-29
Health Canada: Marketed since 2025-08-27 · brand SANDOZ TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tofacitinib: Formulary list price $5.9897/unit (unit not stated in source; not the patient's cost)
Ministry pays: $5.9897 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=104042 · Verify on the e-Formulary ↗ (DIN 02551691)
Source record
DIN 02551691: Sandoz Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id SDZ
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $5.9897; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02551691
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104042
Interchangeable products
Auro-Tofacitinib · DIN 02530007 · $5.9897
Jamp Tofacitinib · DIN 02522896 · $5.9897
PMS-Tofacitinib · DIN 02522799 · $5.9897
Taro-Tofacitinib · DIN 02511304 · $5.9897
Xeljanz · DIN 02423898 · $5.9897
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=02551691
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Taro-Tofacitinib · DIN 02511304 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Taro-Tofacitinib · DIN 02511304
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2023-01-31
Health Canada: Marketed since 2022-11-28 · brand TARO-TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Taro pharmaceuticals inc · schedule Prescription
Taro-Tofacitinib: Formulary list price $5.9897/unit (unit not stated in source; not the patient's cost)
Ministry pays: $5.9897 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=100052 · Verify on the e-Formulary ↗ (DIN 02511304)
Source record
DIN 02511304: Taro-Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id TAR
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $5.9897; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02511304
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100052
Interchangeable products
Auro-Tofacitinib · DIN 02530007 · $5.9897
Jamp Tofacitinib · DIN 02522896 · $5.9897
PMS-Tofacitinib · DIN 02522799 · $5.9897
Sandoz Tofacitinib · DIN 02551691 · $5.9897
Xeljanz · DIN 02423898 · $5.9897
Shortage status: resolved shortage (ended 2025-05-08); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02511304
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Xeljanz · DIN 02423898 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 480, 589, 743 required
Write on scriptLU code 480, 589, 743 (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 480, 589, 743
Reason for Use code 480
For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:
A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR
C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)
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 renewals beyond the second year, the patient must demonstrate 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 5mg administered twice daily
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 743
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15mg/m2 per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.
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 compared to baseline result prior to the start of treatment in the previous year.
For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.
Recommended dose:
In children weighing 40kg or more, 5mg administered orally twice a day.
Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.
Coverage limit:
LU Authorization Period: 1 year
Savings card: RxHelp ONE lists XELJANZ (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim.
(rxhelp.ca ↗)1 brand, same coverage
Xeljanz · DIN 02423898
Manufacturer: Pfizer Canada Inc.; listing date 2016-12-22
Health Canada: Marketed since 2014-06-03 · brand XELJANZ · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 5 MG · company Pfizer canada ulc · schedule Prescription
Ministry pays: $5.9897 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=90863 · Verify on the e-Formulary ↗ (DIN 02423898)
Source record
DIN 02423898: Xeljanz
Raw flags: sec12=Y, sec3=Y
Item: 923600003; group id 1038; item number 2389; lccId 00269; manufacturer id PFI
Source form: Tab; strength: 5mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $24.7733; ministry $5.9897
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02423898
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90863
Interchangeable products
Auro-Tofacitinib · DIN 02530007 · $5.9897
Jamp Tofacitinib · DIN 02522896 · $5.9897
PMS-Tofacitinib · DIN 02522799 · $5.9897
Sandoz Tofacitinib · DIN 02551691 · $5.9897
Taro-Tofacitinib · DIN 02511304 · $5.9897
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=02423898
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Tofacitinib · DIN 02530015 · 10mg · tablet
Limited Use — Reason for Use code 589 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 589 required
Write on scriptLU code 589 (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 589
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Auro-Tofacitinib · DIN 02530015
Manufacturer: Auro Pharma Inc.; listing date 2023-01-31
Health Canada: Marketed since 2022-11-28 · brand AURO-TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 10 MG · company Auro pharma inc · schedule Prescription
Auro-Tofacitinib: Formulary list price $10.5859/unit (unit not stated in source; not the patient's cost)
Ministry pays: $10.5859 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=101924 · Verify on the e-Formulary ↗ (DIN 02530015)
Source record
DIN 02530015: Auro-Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600016; group id 1039; item number 2390; lccId 00341; manufacturer id AUR
Source form: Tab; strength: 10mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $10.5859; ministry $10.5859
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02530015
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101924
Interchangeable products
Sandoz Tofacitinib · DIN 02551705 · $10.5859
Taro-Tofacitinib · DIN 02511312 · $10.5859
Xeljanz · DIN 02480786 · $10.5859
Shortage status: resolved shortage (ended 2025-07-24); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02530015
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Tofacitinib · DIN 02551705 · 10mg · tablet
Limited Use — Reason for Use code 589 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 589 required
Write on scriptLU code 589 (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 589
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Sandoz Tofacitinib · DIN 02551705
Manufacturer: Sandoz Canada Inc.; listing date 2025-09-29
Health Canada: Marketed since 2025-08-27 · brand SANDOZ TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 10 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Tofacitinib: Formulary list price $10.5859/unit (unit not stated in source; not the patient's cost)
Ministry pays: $10.5859 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=104044 · Verify on the e-Formulary ↗ (DIN 02551705)
Source record
DIN 02551705: Sandoz Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600016; group id 1039; item number 2390; lccId 00341; manufacturer id SDZ
Source form: Tab; strength: 10mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $10.5859; ministry $10.5859
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02551705
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104044
Interchangeable products
Auro-Tofacitinib · DIN 02530015 · $10.5859
Taro-Tofacitinib · DIN 02511312 · $10.5859
Xeljanz · DIN 02480786 · $10.5859
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=02551705
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Taro-Tofacitinib · DIN 02511312 · 10mg · tablet
Limited Use — Reason for Use code 589 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 589 required
Write on scriptLU code 589 (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 589
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)1 brand, same coverage
Taro-Tofacitinib · DIN 02511312
Manufacturer: Taro Pharmaceuticals Inc.; listing date 2023-01-31
Health Canada: Marketed since 2022-11-28 · brand TARO-TOFACITINIB · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 10 MG · company Taro pharmaceuticals inc · schedule Prescription
Taro-Tofacitinib: Formulary list price $10.5859/unit (unit not stated in source; not the patient's cost)
Ministry pays: $10.5859 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=100053 · Verify on the e-Formulary ↗ (DIN 02511312)
Source record
DIN 02511312: Taro-Tofacitinib
Raw flags: sec12=Y, sec3=Y
Item: 923600016; group id 1039; item number 2390; lccId 00341; manufacturer id TAR
Source form: Tab; strength: 10mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $10.5859; ministry $10.5859
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02511312
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100053
Interchangeable products
Auro-Tofacitinib · DIN 02530015 · $10.5859
Sandoz Tofacitinib · DIN 02551705 · $10.5859
Xeljanz · DIN 02480786 · $10.5859
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=02511312
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Xeljanz · DIN 02480786 · 10mg · tablet
Limited Use — Reason for Use code 589 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 589 required
Write on scriptLU code 589 (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 589
Reason for Use code 589
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment.
The recommended dosing regimen is 5mg twice daily.
Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.
Coverage limit:
LU Authorization Period: 1 year
Savings card: RxHelp ONE lists XELJANZ (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim.
(rxhelp.ca ↗)1 brand, same coverage
Xeljanz · DIN 02480786
Manufacturer: Pfizer Canada Inc.; listing date 2020-09-30
Health Canada: Marketed since 2019-01-30 · brand XELJANZ · ATC L04AF01 TOFACITINIB · form Tablet · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 10 MG · company Pfizer canada ulc · schedule Prescription
Ministry pays: $10.5859 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=97137 · Verify on the e-Formulary ↗ (DIN 02480786)
Source record
DIN 02480786: Xeljanz
Raw flags: sec12=Y, sec3=Y
Item: 923600016; group id 1039; item number 2390; lccId 00341; manufacturer id PFI
Source form: Tab; strength: 10mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $43.7833; ministry $10.5859
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02480786
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97137
Interchangeable products
Auro-Tofacitinib · DIN 02530015 · $10.5859
Sandoz Tofacitinib · DIN 02551705 · $10.5859
Taro-Tofacitinib · DIN 02511312 · $10.5859
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=02480786
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:36 Disease-Modifying Antirheumatic Agents) and how they are covered
Matched class: 92:36 Disease-Modifying Antirheumatic Agents
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
No displayed product is listed as a general benefit in this extract. Check its listing requirements below.
92:36 Disease-Modifying Antirheumatic Agents
· 3 products ·
Limited Use, codes 637, 684 (1),
Limited Use, codes 684 (2) · strengths: 15mg, 30mg, 45mg · ER Tab
· 30 products ·
Limited Use, codes 600, 601, 602, 603, 604, 605, 606, 607, 609, 611 (23),
Limited Use, codes 600, 602, 603, 604, 605, 606, 607, 609, 633, 634 (7) · strengths: 20mg/0.2mL, 40mg/0.4mL, 20mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL · Inj Sol-0.2mL Pref Syr (Preservative-Free), Inj Sol-0.4mL Autoinj (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Pen (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Syr (Preservative-Free), Inj Sol-0.4mL Pref Pen (Preservative-Free), Inj Sol-0.4mL Pref Syr (Preservative-Free), Inj Sol-0.8mL Pref Autoinj (Preservative-Free), Inj Sol-0.8mL Pref Pen (Preservative-Free), Inj Sol-0.8mL Pref Syr (Preservative-Free)
· 7 products ·
Limited Use, codes 512, 513, 514, 563, 591 (3),
Limited Use, codes 498, 499, 514, 563, 591 (4) · strengths: 25mg/0.5mL, 50mg/mL · Inj Sol-0.5mL Pref Syr Pk, Inj Sol-1mL Pref Syr Pk, Inj Sol-1mL Prefilled SensoReady Pen Pk, Inj Sol-Pref Autoinj Pen, Inj Sol-Pref Syr, Sol- Pref AutoInj
· 6 products ·
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) · strengths: 100mg/Vial, 120mg/mL · Inj Pd-Vial Pk, Inj Sol-1mL Pref Pen Pk (Preservative-Free), Inj Sol-1mL Pref Syr Pk (Preservative-Free), Pd for Sol-Vial Pk
· 10 products ·
Limited Use, codes 697, 698, 720 (6),
Limited Use, codes 697, 698, 720, 721 (4) · strengths: 200mg/10mL, 400mg/20mL, 80mg/4mL, 162mg/0.9mL · Inj Sol-10mL Vial Pk, Inj Sol-10mL Vial Pk (Preservative-Free), Inj Sol-20mL Vial Pk, Inj Sol-20mL Vial Pk (Preservative-Free), Inj Sol-4mL Vial Pk, Inj Sol-4mL Vial Pk (Preservative-Free), Inj Sol-Pref Autoinj, Inj Sol-Pref Autoinj (Preservative-Free), Inj Sol-Pref Syr, Inj Sol-Pref Syr (Preservative-Free)
· 12 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 30mg, 10mg & 20mg & 30mg · Tab, Tab-27 Blister Starter Pk
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:36
Other drugs whose Health Canada label lists a similar indication: active ankylosing spondylitis, moderately to severely active ulcerative colitis
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.
No displayed matched alternative is a general benefit.
GUSELKUMAB · Limited Use, codes 658
(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
IXEKIZUMAB · Limited Use, codes 526
Ankylosing Spondylitis
TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis who
have responded inadequately to, or are intolerant to conventional therapy.
PM: https://pdf.hres.ca/dpd_pm/00080067.PDF; date not captured; DIN 02455102; fetched 2026-09-10
Product monograph
RISANKIZUMAB · Limited Use, codes 574
• 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
Axial spondyloarthritis (axSpA)
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis who have
responded inadequately to conventional therapy (see 14.1.3 Axial spondyloarthritis (axSpA),
Ankylosing spondylitis).
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
USTEKINUMAB · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (6), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (4)
(ustekinumab) is indicated for the treatment of adult patients with moderately to
severely active ulcerative colitis who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
1.1 Pediatrics
Pediatrics (6-17 years of age): Jamteki (ustekinumab) is indicated for the treatment of chronic moderate to
severe plaque psoriasis in pediatric patients (children and adolescents) from 6 to 17 years of age, who are
inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
PM: https://pdf.hres.ca/dpd_pm/00077781.PDF; date November 9, 2023; DIN 02543036; fetched 2026-09-10
Product monograph
Coverage source: ON formulary extract 2026-08-26