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Limited coverage criteria – risankizumab for ulcerative colitis

Last updated on May 27, 2026

 

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Generic name

risankizumab

Strength & form

180 mg/1.2 mL pre-filled, single-use cartridge with on-body injector
360 mg/2.4 mL pre-filled, single-use cartridge with on-body injector
600 mg/10 mL single-use vial

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)

16 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 risankizumab 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 risankizumab 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 risankizumab
  • 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