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Limited coverage criteria – bimekizumab for psoriatic arthritis

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 psoriatic arthritis, when ALL of the following criteria are met:

  • Special Authority request is submitted by a rheumatologist

AND

  • Patient has cutaneous psoriasis OR family history of cutaneous psoriasis

AND

  • All required baseline assessments in applicable domains are submitted1

AND

  • Patient meets either Section A or B below:

Section A: Predominantly peripheral disease

Patient exhibits at least ONE of the following clinical features, despite TWO adequate trials of conventional synthetic disease modifying antirheumatic drugs (csDMARDs) at target dose and duration2:

  • Polyarticular (five or more active joints)
  • Oligoarticular (one to four active joints) with at least one active joint proximal to, or including, the wrist or ankle
  • Dactylitis of two or more digits
  • Tenosynovitis or enthesitis refractory to oral nonsteroidal anti-inflammatory drugs (NSAIDs)3 AND steroid injections (steroid injections not required for Achilles tendon)

Section B: Predominantly axial disease

  • Patient has inflammatory spinal symptoms with positive imaging findings

AND

  • Patient has current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher4

AND

  • Patient has persistent spinal pain despite use of TWO or more NSAIDs3 for a minimum of two weeks each at accepted maximum daily dosages OR has experienced intolerance with NSAID trials

1 year

Renewal

For the continued treatment of adult patients with moderate to severe psoriatic arthritis 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 per the Special Authority request form
  • 2Examples 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, two-month trial of leflunomide 20 mg daily, or an adequate trial of another csDMARD (e.g., cyclosporine, etc.)
  • 3Examples 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
  • 4Current BASDAI is dated within the past three months while on standard therapy
  • PharmaCare coverage will not be provided for bimekizumab in combination with other targeted DMARDs (e.g., biologics, janus kinase inhibitors, etc.) for the treatment of psoriatic arthritis
  • PharmaCare covers a maximum of 56 days' supply per fill of bimekizumab
  • 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