Trelegy and Breo Offer Incremental Improvement Over Generics

Trelegy Ellipta and Breo Ellipta, two drugs selected to be part of the next set of drugs to be assessed under Medicare’s drug price negotiation program, offer the advantage of requiring only one puff once a day compared with other therapies to treat chronic obstructive pulmonary disease (COPD) treatments, according to a special report issued by the Institute for Clinical and Economic Review (ICER). Both inhaler therapies were developed by GSK.

COPD is a lung disease characterized by progressive and persistent airflow obstruction in the lungs. Exacerbations, or flare-ups, of the disease can accelerate the disease and are characterized by worsening symptoms, including increased coughing, wheezing, fatigue and difficulty sleeping. COPD affects an estimated 14.2 million (6.5%) U.S. adults, according to a 2023 study by the Centers for Disease Control. The prevalence is higher among those who are 75 years of age and older.

Trelegy contains three medications: fluticasone, umeclidinium and vilanterol delivered through a once-a-day inhaler. Breo contains two medications: fluticasone and vilanterol delivered through a once-a-day inhaler. Both are approved to treat COPD and asthma.

From November 2023 to October 2024, total Medicare Part D costs for Trelegy Ellipta were $5.1 billion, and total Medicare Part D costs for Breo Ellipta were $1.4 billion, according to CMS.

In this special report, ICER evaluated the evidence of the two COPD treatments and plans to send the public comment submission to CMS as part of its work on Medicare drug price negotiations.

ICER reviewers found that comparators for Trelegy Ellipta generally require multiple 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, although the benefits are modest, according to ICER analysis.

David M. Rind, M.D.

“The drugs themselves don’t make a big difference,” David M. Rind, M.D., chief medical officer at ICER, said in an interview. “That said, there is huge nonadherence and discontinuation in COPD. More than half of people stop using them because they don’t feel better right away when they use the inhalers. In asthma, people feel better right away, so they tend to keep using them; not so much in COPD.”

But Rind said nonadherence is difficult to measure in clinical trials, so ICER assessed observational and real-world studies. Because the clinical evidence review used observational data, ICER rated both Trelegy and Breo as C+, meaning there was comparable or incremental net health benefit compared with generic dual therapies.

In terms of cost-effectiveness, ICER evaluated Trelegy and Breo based on 20 different comparator prices across a range of willingness-to-pay thresholds.

Sarah K. Emond

“We don’t know the actual prices that CMS is paying for those comparators,” ICER’s President and CEO Sarah K. Emond, said in an interview. “We have some data about what it might cost for the comparators for both Trelegy and Breo. And we also don’t know what CMS is currently paying for Trelegy and Breo. We have some general estimates of the rebates that they might be getting.”

The report contains tables that could help CMS determine the cost-effectiveness based on what it pays for each therapy and assess that on equal value of life year (evLY). The evLY is an ICER-developed measure of quality of life based on whether a treatment adds a year of life to a patient population.

CMS decided not to use the quality adjust life year (QALY) metric, a standard measurement for how a treatment improves patients’ lives. The QALY metric has become a standard way to assess health economics but has been criticized as discriminatory.

“The limitations of the QALY metric led us to develop the equal value of life years gained metric,” Emond said. “The evLY values all the time and the life extension the same, no matter if you have other chronic conditions or other disabilities other than the ones being studied. We’re proud of developing a metric that meets the goals of having a more equitable way to measure health gain, and that's why it's our primary measure and the only measure we used for this special assessment.”