Sandoz Tofacitinib · DIN 02551691 · 5mg · tablet
Limited Use — Reason for Use code 480, 589, 743 requiredMarketed · checked 2026-09-19
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: not checked (no credentials)