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Limited coverage drugs – mirikizumab for ulcerative colitis

Last updated on November 19, 2024

 

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Generic name

mirikizumab

Strength & form

300 mg/15 mL vial
100 mg/1 mL pre-filled syringe
100 mg/1 mL pre-filled pen

Special Authority criteria

Approval period

Initial

For the treatment of adult patients with moderate to severe 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 moderate to severe 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

  • With 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 mirikizumab therapy
  • 2Patient must be either steroid resistant (displaying a lack of symptomatic response to therapy) or steroid dependent (defined as: 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 mirikizumab in combination with another biologic drug, a janus kinase (JAK)- inhibitor, or a sphingosine 1-phosphate (S1P) receptor modulator for ulcerative colitis
  • PharmaCare coverage is limited to induction dosages of intravenous mirikizumab of 300 mg every 4 weeks or maintenance dosages of subcutaneous mirikizumab of 200 mg every 4 weeks
  • PharmaCare covers a maximum of 30 days' supply per fill of mirikizumab
  • Additional information expected to assist with processing of coverage requests is detailed on the forms below (and on the eForms published online)

Special Authority requests