Economic evaluations of chronic obstructive pulmonary disease pharmacotherapy: how well are the real-world issues of medication adherence, comorbidities and adverse drug-reactions addressed?

In most registration trials of COPD treatment, strict inclusion and exclusion criteria are applied. During trials, patient monitoring is well controlled. As such, medication adherence is often higher than seen in less controlled, real-world environments with more heterogeneous characteristics. Additionally, safety data collected in trials may not be widely generalizable due to more comorbidity and polypharmacy in the real-world. Consequently, when merely relying on trial data, the impact of adherence, comorbidity and ADRs on the cost-effectiveness can be underestimated. To overcome these real-world data gaps, use of pragmatic trials and observational studies in addition to strictly controlled trial data is recommended. To catalyze implementation of these real-world issues, reporting checklists should be updated.