— Report to reflect legislative specifications in the Inflation Reduction Act and subsequent CMS guidance regarding price negotiations —
BOSTON, September 18, 2024 – The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for CMS on two therapies in high demand for treating chronic obstructive pulmonary disease (COPD). ICER will evaluate Breo Ellipta® and Trelegy Ellipta® (both from GSK). This report will be submitted to CMS as part of the 2025 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2027.
While the final list of drugs subject to negotiation will not be released until February, ICER is developing this report with the expectation that at least one of the drugs being reviewed will be subject to negotiation next year.
“As CMS continues to evolve its drug price negotiation program, we will continue to bring our expertise in comparative clinical effectiveness and value to the conversation,” 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 applying the guidance in a consistent framework, as we did with our special assessment of two drugs subject to the first round of negotiation, offers important information to all stakeholders engaged in this process.”
ICER’s website provides timelines of key posting dates and public comment periods for this report.
For the second round of the Medicare Drug Price Negotiation Program, CMS will announce the next 15 drugs in scope by February 1, 2025. Negotiated prices will be announced by November 30, 2025, and will take effect in 2027.
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.