Limited Coverage Drugs – ozanimod

ozanimod

0.23 mg, 0.46 mg, 0.92 mg 

capsule

Initial approval

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