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Limited Coverage Drugs – ustekinumab for Crohn's disease

Last updated on September 17, 2024

 

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Generic name

ustekinumab

Brand name

Strength

Form

Staqeyma®

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

Special Authority criteria

Approval period

Initial

Moderately to severely active Crohn's disease

For the treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has a Harvey-Bradshaw Index of 8 or higher1 

AND

  • Patient has had an unsuccessful trial of steroids for their current Crohn's disease activity. The trial must include steroid dose equivalent to oral prednisone 40 mg or more daily taken for at least 14 consecutive days. Unsuccessful trial is defined as one of the following:
    • Inadequate response to steroids2
    • Adequate response while on steroids, but with recurrence of disease following tapering or withdrawal of steroids3
    • Inability to complete steroid course due to intolerance or contraindication4

Fistulizing Crohn's disease

For the treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has had an inadequate response or intolerance to a course of ciprofloxacin for a minimum of 3 consecutive weeks at maximally tolerated doses, or
    • Has a contraindication to ciprofloxacin

12 weeks

Renewal

Moderately to severely active Crohn's disease

For the continued treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has a Harvey-Bradshaw Index decrease of at least 4 points, or
    • The total Harvey-Bradshaw Index must be 5 points or less

Fistulizing Crohn's disease

For the continued treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met:

  • Special Authority request is submitted by a gastroenterologist

AND

  • Patient has demonstrated an improvement in the number of and/or severity of fistulae

1 year

Practitioner exemptions

  • None

Special notes

  • 1Moderately to severely active Crohn's disease as defined by a Harvey-Bradshaw Index of 8 or higher following completion of a course of steroids (equivalent to oral prednisone 40 mg or more daily for a minimum of 14 consecutive days)
  • 2Inadequate response to steroids is defined as displaying a lack of symptomatic response to therapy
  • 3Steroid dependence is 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
  • 4The patient's contraindication to steroid therapy or intolerance/adverse effects to a course of steroids (equivalent to oral prednisone 40 mg or more daily for a minimum of 14 consecutive days) must be specified in the Special Authority request for ustekinumab
  • For initial requests for patients who are able to complete a 14-day course of steroids, the patient's Harvey Bradshaw Index worksheet must be completed after a course of at least 14 consecutive days of steroid therapy and prior to their initiation of ustekinumab therapy
  • For initial requests for patients who have had prior surgery or surgeries (such as ostomy, pouch, or prior resection)
  • PharmaCare coverage will not be provided for ustekinumab in combination with other biologic drugs or a janus kinase (JAK)-inhibitor for the treatment of Crohn's disease
  • 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