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BOSTON, September 10, 2026 – 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) on darolutamide (Nubeqa®, Bayer) for treatment of prostate cancer. This report will be submitted to CMS as part of the 2027 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2029.
While the final list of drugs subject to negotiation will not be released until February 2027, ICER is developing this report with the expectation that darolutamide will be subject to negotiation next year. The report will reflect legislative specifications in the Inflation Reduction Act and the most recent CMS guidance regarding price negotiations.
“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 fourth round of the Medicare Drug Price Negotiation Program, CMS is expected to announce the next 15 drugs in scope by February 1, 2027. Negotiated prices are expected to be announced by November 30, 2027, and take effect in 2029.
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