Institute for Clinical and Economic Review Publishes Special Report on COPD Therapies as Part of CMS Public Comment Process on Medicare Drug Price Negotiations

— Report reflects legislative specifications in the Inflation Reduction Act and subsequent CMS guidance —

BOSTON, March 3, 2025 – The Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence of two Chronic Obstructive Pulmonary Disease (COPD) treatments, Trelegy Ellipta® and Breo Ellipta®, that will be sent as its public comment submission to Centers for Medicare & Medicaid Services (CMS) as part of its work on Medicare drug price negotiations. Both of the inhaler therapies were developed by GSK.

Downloads: Final Report 

“Over 15 million people in the United States suffer from COPD. Our special report focuses on the medical evidence and value of these two inhalers, specifically for COPD,” 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 help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”

Key Clinical Findings

Trelegy Ellipta and Breo Ellipta both offer the advantage of requiring only one puff once a day. Comparators for Trelegy Ellipta generally require two inhalers administered twice daily and for Breo Ellipta generally require at least one inhaler twice daily. Observational data suggest that patients are more adherent to once-daily therapy, and this may lead to fewer COPD exacerbations, though the results have at best moderate certainty. Patients we spoke with also stated that they prefer once-daily therapy. There are no important differences in harms between these once daily inhalers and their comparator options.

Thus, we conclude that Trelegy Ellipta has comparable or incremental net health benefits (C+) compared with other generic triple therapies requiring two or more inhalers administered twice daily and that Breo Ellipta has comparable or incremental net health benefit (C+) compared with generic inhaled corticosteroid/ long-acting beta-agonist dual therapies administered twice daily.

Comparative Effectiveness and Cost Findings

ICER framed the price threshold calculations as estimated annual prices that CMS should pay based on comparator prices. In these calculations, the comparators represent any potential treatment alternatives, including low-cost generics, authorized generics, and heavily discounted branded therapies. Tables of appropriate prices across a wide range of threshold pricing and comparator pricing are presented in the report (table ES3 and table ES5) since the prices paid by CMS for the comparators are not publicly available.

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.