Long-term cost-effectiveness of the fixed-dose combination of tiotropium plus olodaterol based on the DYNAGITO trial results

Martine Hoogendoorn,1 Isaac Corro Ramos,1 Michael Baldwin,2 Laura Luciani,3 Cecile Fabron,4 Bruno Detournay,4 Maureen PMH Rutten-van Mölken1,5 1institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, the Netherlands; 2Boehringer Ingelheim GmbH, Ingelheim, Germany; 3Boehringer Ingelheim France, Paris, France; 4Cemka-Eval, Bourg-la-Reine, France; 5Erasmus School of Health Policy & Management (ESHPM), Erasmus University Rotterdam, Rotterdam, the Netherlands Purpose: Combinations of long-acting bronchodilators are recommended to reduce the rate of COPD exacerbations. Evidence from the DYNAGITO trial showed that the fixed-dose combination of tiotropium + olodaterol reduced the annual rate of total exacerbations (P<0.05) compared with tiotropium monotherapy. This study aimed to estimate the cost-effectiveness of the fixed-dose combination of tiotropium + olodaterol vs tiotropium monotherapy in COPD patients in the French setting. Patients and methods: A recently developed COPD patient-level simulation model was used to simulate the lifetime effects and costs for 15,000 patients receiving either tiotropium + olodaterol or tiotropium monotherapy by applying the reduction in annual exacerbation rate as observed in the DYNAGITO trial. The model was adapted to the French setting by including French unit costs for treatment medication, COPD maintenance treatment, COPD exacerbations (moderate or severe), and pneumonia. The main outcomes were the annual (severe) exacerbation rate, the number of quality-adjusted life-years (QALYs), and total lifetime costs. Results: The number of QALYs for treatment with tiotropium + olodaterol was 0.042 higher compared with tiotropium monotherapy. Using a societal perspective, tiotropium + olodaterol resulted in a cost increase of +€123 and an incremental cost-effectiveness ratio (ICER) of €2,900 per QALY compared with tiotropium monotherapy. From a French National Sickness Fund perspective, total lifetime costs were reduced by €272 with tiotropium + olodaterol, resulting in tiotropium + olodaterol being the dominant treatment option, that is, more effects with less costs. Sensitivity analyses showed that reducing the cost of exacerbations by 34% increased the ICER to €15,400, which could still be considered cost-effective in the French setting. Conclusion: Treatment with tiotropium + olodaterol resulted in a gain in QALYs and savings in costs compared with tiotropium monotherapy using a National Sickness Fund perspective in France. From the societal perspective, tiotropium + olodaterol was found to be cost-effective with a low cost per QALY. Keywords: COPD, tiotropium, olodaterol, exacerbations, modeling, QALYs, cost