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Limited Coverage Drugs – ustekinumab for ulcerative colitis

Last updated on September 17, 2024

 

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Generic name

ustekinumab

Brand

Strength

Form
Wezlana™ 90 mg/1 mL
130 mg/26 mL (5 mg/mL)		 pre-filled, single-use syringe for subcutaneous injection
single-use vial for intravenous infusion

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 physicians 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)

12 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 ustekinumab 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 ustekinumab in combination with a biologic drug, a janus kinase (JAK)-inhibitor, or a sphingosine 1-phosphate (S1P) receptor modulator for ulcerative colitis
  • PharmaCare coverage is limited to maintenance dosages of subcutaneous ustekinumab of 90 mg every 8 weeks
  • PharmaCare covers a maximum of 84 days' supply per fill of ustekinumab
  • 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