Institute for Clinical and Economic Review to Undertake Special Report on Crohn’s Disease and Ulcerative Colitis for CMS as Part of Public Comment Process on Medicare Drug Price Negotiations

— Report to reflect legislative specifications in the Inflation Reduction Act and most recent CMS guidance regarding price negotiations —

BOSTON, September 15, 2025 – The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) for treating Crohn’s disease and ulcerative colitis. ICER will evaluate Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.). This report will be submitted to CMS as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028.  

While the final list of drugs subject to negotiation will not be released until February 2026, ICER is developing this report with the expectation that Entyvio® will be subject to negotiation next year.  

“Building on our two previous reports, ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework offers important information to all stakeholders engaged in this process.”

The research protocol is now available.

ICER’s website provides timelines of key posting dates and public comment periods for this assessment.

For the second round of the Medicare Drug Price Negotiation Program, CMS will announce the next 15 drugs in scope by February 1, 2026. Negotiated prices will be announced by November 30, 2026, and will take effect in 2028. 

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.