Xeljanz XR · DIN 02470608 · 11mg · extended release tablet
Limited Use — Reason for Use code 565 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 565 required
Write on scriptLU code 565 (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 565
Reason for Use code 565
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 11mg once daily.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Xeljanz XR · DIN 02470608
Manufacturer: Pfizer Canada Inc.; listing date 2019-08-30
Health Canada: Marketed since 2018-03-29 · brand XELJANZ XR · ATC L04AF01 TOFACITINIB · form Tablet (extended-release) · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 11 MG · company Pfizer canada ulc · schedule Prescription
Ministry pays: $27.2507 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=95960 · Verify on the e-Formulary ↗ (DIN 02470608)
Source record
DIN 02470608: Xeljanz XR
Raw flags: sec12=Y, sec3=Y
Item: 923600015; group id 1040; item number 2391; lccId 00320; manufacturer id PFI
Source form: ER Tab; strength: 11mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $49.5467; ministry $27.2507
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02470608
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95960
Interchangeable products
Taro-Tofacitinib XR · DIN 02553988 · $27.2507
Shortage status: not checked (no credentials)