Estimating the Value of Ensifentrine in Addition to Background Maintenance Therapy for the Treatment of Chronic Obstructive Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) is a group of progressive lung diseases, leading to increased healthcare use, expenditures, and risk of mortality. In June 2024, the Institute for Clinical and Economic Review (ICER) released a traditional cost-effectiveness analysis (CEA) of ensifentrine + background maintenance therapy (BMT) for the treatment of moderate-to-severe COPD. This study's objective is to analyze the sensitivity of ICER's traditional CEA methods to various adjustments to their model, including Generalized Cost-Effectiveness Analysis (GCEA) elements such as generalized risk-adjusted cost-effectiveness (GRACE), dynamic pricing, and stacked cohorts. A Markov model simulated the value of ensifentrine + BMT relative to BMT only for treating moderate-to-severe COPD, with patients transitioning across health states defined by levels of lung functionality. We estimated the annual value-based prices (VBPs) and incremental cost-effectiveness ratios of ensifentrine + BMT relative to BMT using traditional CEA and GCEA methods, including multiple scenario analyses. The VBP of ensifentrine + BMT is estimated at $61,008 when all GCEA elements are included. Relative to the traditional CEA static pricing scenario, GRACE increases VBPs by roughly 10 %, while dynamic pricing increases VBPs by 7-11 %. Stacked cohorts with dynamic pricing increases VBPs by 86-170 %. When including GCEA elements and adjustments to better reflect real-world COPD clinical pathways, ensifentrine + BMT is cost-effective below an annual price of $61,000 at a willingness-to-pay of $150,000 per quality-adjusted life-year.