Inflammatory Bowel Oral – NC Standard

Restricted Product(s):

• OrtikosTM (budesonide ER) capsule
• Pentasa® (mesalamine ER) capsule
• Uceris® (budesonide ER 9 mg) tablet

FDA Approved Use:

• Ortikos
  • For the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older.
  • For the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.
• Pentasa
  • For the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
• Uceris
  • For the induction of remission in patients with active, mild to moderate ulcerative colitis.

Criteria for Approval of Restricted Product(s):

1. The requested medication is Ortikos (budesonide ER) capsule or Uceris (budesonide ER 9 mg) tablet; AND
   1. The patient has tried and failed a topical (rectal) 5-aminosalicylate (5-ASA) therapy at a therapeutic dose (i.e. 1 gram/day)1; OR
   2. The patient has a documented allergy, intolerance, or contraindication to a topical (rectal) 5-aminosalicylate (5-ASA) therapy1; OR
   3. The patient has tried and failed an oral 5-aminosalicylate (5-ASA) therapy; OR
   4. The patient has a documented allergy, intolerance, or contraindication to an oral 5-aminosalicylate (5-ASA) therapy; AND
   5. If the requested medication is Ortikos, the patient is 8 years of age and older; OR
2. The requested medication is Pentasa (mesalamine ER) capsule; AND
   1. The requested medication is being used for the induction of remission and maintenance treatment of mild to moderate active ulcerative colitis; AND
   2. The patient has had a trial and failure of TWO unrestricted, formulary oral 5-aminosalicylate (5-ASA) medications2; OR
   3. The patient has a contraindication/intolerance to the unrestricted, formulary oral 5-aminosalicylate (5-ASA) medications that have not been tried; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

1. ACG Clinical Guideline: Ulcerative Colitis in Adults, The American Journal of GASTROENTEROLOGY, 22 Feb. 2019, s3.gi.org.libproxy.lib.unc.edu/physicians/guidelines/UlcerativeColitis.pdf.
2. Sutherland L, Roth D, Beck P, et al. Oral 5-aminosalicylic acid for maintaining remission in ulcerative colitis. Cochrane Database Syst Rev 2000; :CD000544.uc

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

May 2022: Criteria update: Added notation that policy applies to brand and generics. Updated duration of approval to 1 year for all products.

July 2020: Criteria update: Added new to market Ortikos to the policy. Removed unrestricted alternatives section.

Dec 2019: Criteria update: Added Mesalamine 0.375 gm ER capsule (generic Apriso) to the unrestricted alternatives section.

Oct 2019: Criteria update: Brand Delzicol removed from preferred brand alternative due to generic launch

Jul 2019: Original utilization management criteria issued.