Limited coverage criteria – tofacitinib for ankylosing spondylitis

Last updated on July 16, 2025

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Generic name		tofacitinib
Strength & form		5 mg tablet

Special Authority criteria	Approval period
Initial For the treatment of adult patients (≥ 18 years of age) with moderate to severe ankylosing spondylitis, when ALL of the following criteria are met: Special Authority request is submitted by a rheumatologist AND All required baseline assessments in applicable domains are submitted¹ AND Patient meets the requirements for either predominantly axial or predominantly peripheral disease as detailed below: For predominantly axial disease Patient has current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher² AND Patient has positive imaging finding of ankylosing spondylitis OR, in the absence of positive imaging finding, patient is human leukocyte antigen (HLA) B27 positive AND has at least two spondyloarthropathy (SpA) features³ AND Patient has persistent spinal pain despite use of TWO or more nonsteroidal anti-inflammatory drugs (NSAIDs) for a minimum of two weeks each at accepted maximum daily dosages OR has experienced intolerance with NSAID trials⁴ For predominantly peripheral disease Patient has active joints OR patient has active tenosynovitis and/or enthesitis despite adequate trials of TWO conventional synthetic disease modifying antirheumatic drugs (csDMARDs) at target dose and duration⁵	1 year
Renewal For the continued treatment of adult patients with moderate to severe ankylosing spondylitis when ALL of the following criteria are met: Special Authority request is submitted by a rheumatologist AND Patient has attained and maintained beneficial clinical effect, defined as an overall 20% or greater improvement from baseline in applicable domains¹	1 year, 3 years, or indefinite⁶

Special Authority criteria

Approval period

Initial

For the treatment of adult patients (≥ 18 years of age) with moderate to severe ankylosing spondylitis, when ALL of the following criteria are met:

Special Authority request is submitted by a rheumatologist

AND

All required baseline assessments in applicable domains are submitted¹

AND

Patient meets the requirements for either predominantly axial or predominantly peripheral disease as detailed below:

For predominantly axial disease

Patient has current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher²

AND

Patient has positive imaging finding of ankylosing spondylitis OR, in the absence of positive imaging finding, patient is human leukocyte antigen (HLA) B27 positive AND has at least two spondyloarthropathy (SpA) features³

AND

Patient has persistent spinal pain despite use of TWO or more nonsteroidal anti-inflammatory drugs (NSAIDs) for a minimum of two weeks each at accepted maximum daily dosages OR has experienced intolerance with NSAID trials⁴

For predominantly peripheral disease

Patient has active joints OR patient has active tenosynovitis and/or enthesitis despite adequate trials of TWO conventional synthetic disease modifying antirheumatic drugs (csDMARDs) at target dose and duration⁵

1 year

Renewal

For the continued treatment of adult patients with moderate to severe ankylosing spondylitis when ALL of the following criteria are met:

Special Authority request is submitted by a rheumatologist

AND

Patient has attained and maintained beneficial clinical effect, defined as an overall 20% or greater improvement from baseline in applicable domains¹

1 year, 3 years, or indefinite⁶

Practitioner exemptions

None

Special notes

¹Applicable domains may include the following: physician global assessment (PGA) of inflammation, duration of morning stiffness, Health Assessment Questionnaire (HAQ), BASDAI, or baseline clinical features (e.g., number of active joints affected, active tenosynovitis and/or enthesitis, etc.) as per the Special Authority request form
²Current BASDAI is dated within the past three months while on standard therapy
³Provide confirmation that the patient is HLA B27 positive and has at least two of the following additional SpA features: inflammatory back pain, arthritis, enthesitis, uveitis, dactylitis, psoriasis, inflammatory bowel disease (IBD), history of adequate response to NSAIDs, family history of SpA, or elevated C-reactive protein (CRP)
⁴Examples of maximum daily doses of NSAIDs: naproxen 1000-1500 mg, ibuprofen 1800-2400 mg, diclofenac 100 mg, celecoxib 200 mg, meloxicam 15 mg, indomethacin 150 mg, flurbiprofen 200 mg. If intolerant, details of the intolerance experienced must be provided
⁵Examples of adequate trials of csDMARDs include: a three-month trial of methotrexate 25 mg parenterally weekly (15 mg parenterally if over 65 years of age), three-month trial of sulfasalazine 3 g daily
⁶Three-year or indefinite coverage durations for tofacitinib renewals for ankylosing spondylitis are only considered for patients on a dosage of 5 mg twice daily, when requested, and in situations where stability has been demonstrated
PharmaCare coverage will not be provided for tofacitinib in combination with other targeted DMARDs (e.g., biologics, janus kinase inhibitors, etc.) for the treatment of ankylosing spondylitis
PharmaCare covers a maximum of 30 days' supply per fill of tofacitinib
Additional information expected to assist with processing of coverage requests is detailed on the forms linked below (and on the eForms published online)

Special Authority requests

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