Ulcerative Colitis

Affects approximately 900,000 people in the U.S.·9 treatments

Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers in the innermost lining of the large intestine and rectum. Unlike Crohn's, it affects only the colon. Symptoms include bloody diarrhea, abdominal pain, urgency, and fatigue. Severe cases can lead to toxic megacolon, a life-threatening emergency.

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Standard step therapy requires trial of oral 5-ASAs (mesalamine) and often an immunomodulator (azathioprine or 6-MP) before biologic therapy. Corticosteroids are used for acute flares but not long-term maintenance. For moderate-to-severe UC failing conventional therapy, TNF inhibitors (infliximab, adalimumab), integrin inhibitors (Entyvio), IL-12/23 inhibitors (Stelara), and JAK inhibitors are available.

Must fail 5-ASAs (mesalamine) and immunomodulators before biologic therapy

Very Common

Biosimilar infliximab required before brand Remicade

Common

Endoscopic evidence of moderate-to-severe disease not submitted

Common

Tofacitinib (Xeljanz) denied due to FDA black-box warning

Occasional

Switching between biologics denied without loss of response documentation

Occasional

  1. 1.Document Mayo score or partial Mayo score showing moderate-to-severe disease
  2. 2.Include endoscopy findings with Mayo endoscopic subscore
  3. 3.Document prior 5-ASA and immunomodulator failures with dates and doses
  4. 4.For steroid-dependent patients, document inability to taper below a threshold dose
  5. 5.Include fecal calprotectin, CRP, and hemoglobin to demonstrate disease burden

Active clinical trials that may provide treatment at no cost.

Copay cards, patient assistance programs, and foundation grants for this condition's treatments.

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