The German Institute for Quality and Efficiency in Health Care (IQWiG) recently examined a recent therapeutic drug combination — aclidinium bromide/formoterol — approved as a treatment for adults with chronic obstructive pulmonary disease (COPD), since November 2014. The study focused on understanding whether aclidinium bromide/formoterol added a significant therapeutic value when compared with other standard therapies.
The authors concluded after revising the drugs’ dossier that adult patients with moderate COPD (Grade II) benefited mildly from combining aclidinium bromide with formoterol, whereas those exhibiting grade III and fewer than 2 exacerbations (flare-ups) per year, improved considerably with the drug combination when compared in both cases with the comparator therapy. The effects on patients at more advanced stages of COPD disease remains unknown.
Another institution, The Federal Joint Committee (G-BA) — a public entity that includes organizations from the German healthcare system — also performed an independent analysis of the added benefits of aclidinium bromide/formoterol by comparing it to several comparator therapies according to disease severity. The analysis found that for moderate COPD severity stages, the comparator therapy is long-acting beta-2 sympathomimetic (such as formoterol) and/or tiotropium; for severe COPD stages, namely grade III and at least two flare-ups per year, the comparator therapy was the same plus the additional use of an inhaled corticosteroid.
However, the data submitted by the drugs’ manufacturer was contradictory with the G-BA recommendations, with patients with moderate to severe COPD taking aclidinium bromide/formoterol directly compared to formoterol and with the option to continue treatment with an inhaled corticosteroid independently on disease severity grade and frequency of exacerbations. As a result, the G-BA analysis was performed only with data in agreement with their previously presented guidelines. As such, patients with COPD grade IV remained outside the analysis, since there was no data available in agreement with the suggested approach; for patients with grade III or IV and at least two flare-ups per year, the G-BA found no added benefit with the recent therapeutic drug combination, aclidinium bromide/formoterol.
In a broader analysis with an E-RS questionnaire where patients were questioned for improvements in breathlessness, cough and sputum, chest symptoms, G-BA registered an added benefit for patients with grade II and grade III. The latter group also indicated an added benefit for those with “severe exacerbations.” The analysis of patients with COPD grade IV was unknown due to lack of data.
In conclusion, therapeutic drug combination — aclidinium bromide/formoterol — was found to add a significant benefit to patients with COPD grade III with only one flare-up per year, while patients with moderate severity present mild added benefits.