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Limited coverage criteria – ozanimod

Last updated on March 26, 2025

 

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Generic name

ozanimod

Strength & form

0.23 mg/0.46 mg/0.92 mg, capsule

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:

  • Prescribed by a gastroenterologist
  • Patient has a partial Mayo score1 of at least 4 for the sum of stool frequency, rectal bleeding, and physician's global assessment AND
    with a rectal bleeding subscore of at least 2
  • Patient has had a trial of 5-ASA products for a minimum of 4 weeks
  • 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)

14 weeks

Renewals

For the continued treatment of adult patients with moderate to severe ulcerative colitis when ALL of the following criteria are met:

  • Prescribed by a gastroenterologist
  • 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 patient has 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 ozanimod 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 ozanimod in combination with a biologic drug for ulcerative colitis or ozanimod in combination with a JAK-inhibitor for ulcerative colitis
  • PharmaCare coverage will not be provided for ozanimod dosages exceeding 0.92 mg daily
  • PharmaCare covers a maximum of 35 days supply per fill of ozanimod. Coverage is limited to once-daily dosing
  • Special Authority request must be submitted by a gastroenterologist

Special Authority request form(s)