Cost-effectiveness of twice-daily indacaterol/glycopyrrolate inhalation powder for the treatment of moderate to severe COPD in the US

Background: Indacaterol 27.5 mu g/glycopyrrolate 15.6 mu g (IND/GLY 27.5/15.6 mu g) inhalation powder, a twice-daily, fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting antimuscarinic antagonist (LAMA), is indicated in the US for long-term maintenance treatment of airflow obstruction in patients with COPD. The safety and efficacy of IND/GLY 27.5/15.6 mu g have been established, but cost-effectiveness is not yet known. This study compared the cost-effectiveness of IND/GLY 27.5/15.6 mu g with other long-acting COPD maintenance therapies. Methods: A Markov model was constructed from the US payer perspective. Health states were defined as mild (post-bronchodilator FEV1 >= 80% of predicted), moderate (50% <= FEV1, <80% of predicted), severe (30% <= FEV1, <50% of predicted), and very severe (FEV1, <30% of predicted) COPD. Patients entering the model transitioned through health states based on placebo-adjusted change from baseline in trough FEV1 for each comparator at week 12. Comparators included other US Food and Drug Administration-approved LABA/LAMA fixed-dose combinations as well as commonly prescribed LAMA and LABA/inhaled corticosteroid agents. One-way and probabilistic sensitivity analyses were conducted to test the model assumptions and the overall robustness of the results. Results: Using the model, IND/GLY 27.5/15.6 mu g treatment for 12 weeks resulted in total costs of US $23,375 vs US $9,365 for placebo. Compared with placebo, IND/GLY 27.5/15.6 treatment resulted in the highest improvement in FEV1 across all comparators and the lowest cost per decline in 100 mL FEV1. IND/GLY 27.5/15.6 mu g was also among the most costeffective treatment option as measured by St George's Respiratory Questionnaire response rate, at US $3,518 per additional responder at 12 weeks compared with placebo. In addition, IND/GLY 27.5/15.6 mu g had the lowest cost per severe exacerbation avoided vs placebo across all comparators (US $87,686). Conclusion: This model, developed from the US payer perspective with a 5-year time horizon, found IND/GLY 27.5/15.6 mu g to be a cost-effective treatment option for patients with moderate to severe COPD.