Product Details

Xeljanz XR

Tofacitinib Citrate
11 mg
ER Tablet


DIN/PIN/NPN

02470608

Manufacturer

Pfizer Canada Inc.

Formulary Listing Date

2019-08-30  

Unit Price

49.5467

Amount MOH Pays

37.1600

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AF01

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02470608 Xeljanz XR 49.5467 37.1600
02553988 Taro-Tofacitinib XR 37.1600 37.1600
 

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
565 1 year

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.

 

EAP Criteria

NO

Product Monograph

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