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BOSTON, March 3, 2026 – The Institute for Clinical and Economic Review (ICER) today posted a Special Report on Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.) for the treatment of ulcerative colitis and Crohn’s disease. This report will be submitted to the Centers for Medicare & Medicaid Services (CMS) as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028.
Downloads: Final Report
“Over three million people in the United States suffer from inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. Our special report focuses on the medical evidence for and value of Entyvio, which is commonly used to treat both conditions,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will support their ongoing efforts to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
Key Clinical Findings
The report provides background information on both diseases, treatment, patient experience, clinical outcomes, and comparisons with other treatments. For the assessment of the comparative clinical effectiveness of Entyvio, ICER examined several comparators including other biologic therapies commonly used for inflammatory bowel diseases: ustekinumab, infliximab, and adalimumab. A summary of those results is below.
Entyvio compared to Ustekinumab:
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ICER rated Entyvio as (C-), comparable or inferior, to ustekinumab for treatment of ulcerative colitis. For the patient-important outcomes of response, remission, and discontinuations due to serious adverse events, there were no significant differences, nor were there any important differences in observational data. However, the trend was for higher rates of response, remission, and fewer discontinuations due to AEs with ustekinumab.
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ICER rated Entyvio as (C), comparable, to ustekinumab for treatment of Crohn’s disease. For the outcomes of response, remission, and discontinuation due to serious adverse events, there were no significant differences, nor were there any important differences in observational data.
Entyvio compared to Infliximab and Adalimumab:
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ICER rated Entyvio as (C+), comparable or better, than infliximab and adalimumab for treatment of ulcerative colitis and Crohn’s disease. For the patient-important outcomes of response, remission, and discontinuations due to serious adverse events, there were no significant differences. However, there were fewer serious infections with Entyvio in observational data, and both infliximab and adalimumab carry black box warnings for serious infections and malignancies.
Price Calculations
ICER framed its price threshold calculations as the price premiums that CMS should pay for Entyvio over the pricing of two key therapeutic alternatives, infliximab and ustekinumab, for treatment of ulcerative colitis or Crohn’s disease.
For both ulcerative colitis and Crohn’s disease, ICER modeled the relative advantage of Entyvio over infliximab in keeping patients in remission. ICER also modeled the relative advantage of preventing the need for colectomy in ulcerative colitis and surgeries in Crohn’s disease.
Current evidence supports a 30-day premium of $210 to $230 above what CMS is currently paying for infliximab. Price premiums were weighted based on estimated proportionate use for Crohn’s disease and ulcerative colitis. Price premiums can be adjusted by CMS to reflect actual proportionate use.
Compared to ustekinumab, Entyvio was not associated with important health gains in ulcerative colitis or Crohn’s disease. Modeling confirmed that the evidence does not support a price premium for Entyvio above CMS pricing for ustekinumab, suggesting that a reference pricing strategy may be appropriate.
Thirty-day threshold price premiums for Entyvio across a range of cost-effectiveness benchmarks are presented in the report (Table ES5).
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