Inflammatory Bowel Oral – NC Standard

Restricted Product(s)

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

Unrestricted/ Suggested Alternative(s)

Preferred Brands

• Apriso 0.375 gm capsule 
• Delzicol 400 mg capsule 

Generics

• Balsalazide 750mg capsule 
• Budesonide DR 3 mg capsule (generic Entocort EC) 
• Mesalamine 1.2 gm tablet (generic Lialda) 
• Mesalamine 800 mg DR tablet (generic Asacol) 
• Mesalamine 1000mg suppository (generic Canasa) 
• Sulfasalazine tablet 
• Mesalamine enema

FDA Approved Use

• Uceris 
  • Induction of remission in patients with active ulcerative colitis (mild to moderate) 
• Pentasa 
  • Treatment and maintenance of remission of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Rationale

Uceris (budesonide ER 9 mg tablet) and Pentasa (mesalamine ER capsule) can be used in attempts to treat conditions that have not been validated by the FDA. This program ensures that members are receiving these medications for conditions that have the appropriate evidence to support its use. Other products, such as generic budesonide delayed release and mesalamine, respectively treat the same condition at a lower cost for members. 

Criteria Summary

FDA approved use/Medical necessity; trial of effective and lower cost agent

Criteria for Approval of Restricted Product(s)

1. The requested medication is Uceris (budesonide ER 9 mg) tablet; AND
   1. The patient has tried and failed a topical (rectal) 5-aminosalicylate (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 (ASA) therapy1 ; OR 
   3. The patient has tried and failed an oral 5-aminosalicylate (ASA) therapy; OR 
   4. The patient has a documented allergy, intolerance, or contraindication to an oral 5-aminosalicylate (ASA) therapy; 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 oral 5-aminosalicylate (ASA) unrestricted medications2 ; OR 
   3. The patient has a contraindication/intolerance to the oral 5-aminosalicylate (ASA) unrestricted medications that have not been tried; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)*

Duration of Approval
Uceris (budesonide ER 9mg): 365 days (1 year)
Pentasa (mesalamine ER) capsule: 1095 days (3 years)

*Non-formulary Exception Criteria

Non-Formulary Exception criteria applies on formularies which exclude requested product(s). Satisfactory completion of criteria points (above) may satisfy some, or all, portions of the Non-Formulary Exception Criteria. This criteria is summarized as: a) Request must be for an FDA approved indication; AND b) Patient must have a trial and failure of up to TWO formulary medications or a clinical contraindication/intolerance to those medications not tried. 

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.
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

Originated: July 2019

Jul 2019: Original utilization management criteria issued.

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