Limited coverage criteria – bimekizumab for ankylosing spondylitis

Last updated on July 16, 2025

 

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Generic name

bimekizumab

Strength & form

160 mg/mL solution for subcutaneous (SC) injection in a pre-filled syringe or pre-filled autoinjector

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

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 detailed on 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), a three-month trial of sulfasalazine 3 g daily
  • PharmaCare coverage will not be provided for bimekizumab in combination with other targeted DMARDs (e.g., biologics or janus kinase inhibitors, etc.) for the treatment of ankylosing spondylitis
  • PharmaCare covers a maximum of 56 days' supply per fill of bimekizumab
  • Additional information expected to assist with processing of coverage requests is detailed in the forms linked below (and on the eForms published online)

Special Authority request form(s)