Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that affects the mucosa, the innermost lining of the intestinal wall in the large bowel (i.e., the colon and rectum). The disease is typically diagnosed between age 15 and 35 and causes longlasting inflammation and ulcers in the digestive tract. Symptoms may include frequent diarrhea, sometimes with blood or pus, abdominal and/or rectal pain, weight loss, and fatigue. When the disease affects children, it can have a detrimental impact on growth, nutritional status, and psychosocial development. It is estimated that approximately 900,000 individuals in the United States have UC; the economic burden of UC is significant, ranging between $15-32 billion per year, including lost productivity at work and/or school

The independent appraisal committee voted that evidence was adequate to demonstrate clinical superiority of vedolizumab over adalimumab.

Treatments of Interest:

  • Vedolizumab (Entyvio®, Takeda)
  • Infliximab (Remicade®, Janssen)
  • Infliximab-dyyb (Inflectra®, Pfizer)
  • Infliximab-abda (Renflexis®, Merck)
  • Adalimumab (Humira®, AbbVie)
  • Golimumab (Simponi®, Janssen)
  • Tofacitinib (Xeljanz®, Pfizer)
  • Ustekinumab (Stelara®, Janssen)

Date of Review: September 2020

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Final Documents

Below you will find the final documents from the assessment review process:

ICER Chief Scientific Officer Pamela Bradt, MD, MPH, stated:

“Ulcerative colitis can create a lot of suffering for patients and their families and caregivers. Fortunately, for patients not receiving adequate response to conventional immune modulator treatment, the evidence clearly demonstrates that targeted immune modulators often produce durable periods of clinical remission of ulcerative colitis symptoms, allowing patients to resume normal activities. However, there is very little head-to-head data comparing treatment options in this increasingly crowded, and expensive, therapy class. Prices are generally too high, even for the significant clinical benefits obtained, but the advent of biosimilars for infliximab has led to dramatic price decreases for this one agent and its biosimilars, displaying the potential cost savings that biosimilars may be able to deliver more broadly in the US. In the meantime, insurers use prior authorization, step therapy, and switching policies to try to manage the inappropriate pricing in this area, but they need to take specific actions to ensure that these policies do not prevent patients from being able to get appropriate care at a price they can afford.”