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Limited coverage criteria – guselkumab for ulcerative colitis

Last updated on May 27, 2026

 

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Generic name

guselkumab

Strength & form

100 mg/mL pre-filled syringe (100 mg)
100 mg/mL auto-injector (100 mg)
100 mg/mL pre-filled pen (100 mg)
100 mg/mL pre-filled pen (200 mg)
10 mg/mL vial (200 mg)

Special Authority criteria

Approval period

Initial

For the treatment of adult patients with moderately to severely active ulcerative colitis when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has a partial Mayo score1 of at least 4 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and
    • patient has a rectal bleeding subscore of at least 2

AND

  • Patient has had a trial of 5-ASA products for a minimum of 4 weeks

AND

  • Patient has had a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days2, or
    • patient is unable to complete a course of steroids equivalent to oral prednisone 40 mg or more daily for a minimum of 14 days due to contraindication(s) or intolerance(s)/adverse event(s)

24 weeks

Renewal

For the continued treatment of adult patients with moderately to severely active ulcerative colitis when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has a partial Mayo score reduction from baseline of at least 2 for the sum of stool frequency, rectal bleeding, and physician's global assessment, and
    • a decrease in baseline rectal bleeding subscore of at least 1, or
      • a rectal bleeding subscore of 0 or 1
 1 year

Practitioner exemptions

  • None

Special notes

  • 1Patient's partial Mayo score must be completed after their course of therapy of 5-ASA and steroids and prior to their initiation with guselkumab therapy
  • 2Patient must either be steroid resistant (displaying a lack of symptomatic response to therapy) or steroid dependent (unable to withdraw oral corticosteroid within 3 months of initiation without a recurrence of symptoms; a symptomatic relapse within 3 months of stopping; or the need for 2 or more courses of corticosteroids within 1 year)
  • PharmaCare coverage will not be provided for guselkumab in combination with another biologic drug, a janus kinase (JAK)-inhibitor, or a sphingosine 1-phosphate (S1P) receptor modulator for ulcerative colitis
  • PharmaCare covers a maximum of 56 days' supply per fill of guselkumab
  • 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