Aclidiniumbromid (1) – Eklira Genuair, Bretaris Genuair®, Bretaris® Genuair®

• Clinical trials
  • In the benefit assessment dossier submitted in accordance with Section 35a of the German Social Code, Book V (SGB V), the pharmaceutical manufacturer presented two direct comparative randomised trials to demonstrate the additional benefit of aclidinium bromide compared with tiotropium bromide.

a) Patients from treatment stage II onwards

• No proof of an additional benefit of aclidinium bromide over the appropriate comparator therapy has been provided.
• The study duration of the submitted studies was not long enough to provide proof of additional benefit for patient-relevant endpoints in the context of COPD, a chronically progressive disease, particularly as aclidinium bromide is a medicinal product intended for long-term use.
• Numerous discrepancies between the data from the original documents and those presented in Module 4 of the dossier resulted in the poor quality of the indirect comparison submitted, meaning that a valid assessment of the additional benefit of aclidinium bromide compared with the appropriate comparator therapy was not possible on the basis of the data presented in the dossier.
• The pharmaceutical manufacturer used the SGRQ questionnaire (Saint George’s Respiratory Questionnaire) in its studies to measure quality of life; however, for the reasons mentioned above, the quality of the data processing was not sufficient to allow for an evaluation of the data.
• A questionnaire designed to determine patient preference is not suitable for validly assessing health-related quality of life.
• In the aclidinium bromide studies outlined in the dossier, no instrument was used to measure physical exercise capacity. Consequently, no data are available for aclidinium bromide regarding this endpoint.

b) Patients from treatment stage III/IV with more than two exacerbations

• No additional benefit of aclidinium bromide over the appropriate comparator therapy has been proven.
• The study duration submitted was not long enough to provide proof of additional benefit for patient-relevant endpoints in the context of COPD, a chronically progressive disease, particularly as aclidinium bromide is a medicinal product intended for long-term use.
• Numerous discrepancies between the data from the original documents and those presented in Module 4 of the dossier resulted in the poor quality of the indirect comparison submitted, meaning that a valid assessment of the additional benefit of aclidinium bromide compared with the appropriate comparator therapy was not possible on the basis of the data presented in the dossier.
• The pharmaceutical manufacturer used the SGRQ questionnaire (Saint George’s Respiratory Questionnaire) in its studies to measure quality of life; however, for the reasons mentioned above, the quality of the data processing was not sufficient to allow for an evaluation of the data.
• A questionnaire designed to determine patient preference is not suitable for validly assessing health-related quality of life.
• In the aclidinium bromide studies set out in the dossier, no instrument was used to measure physical exercise capacity. Consequently, no data are available for aclidinium bromide regarding this endpoint.

Courtesy translation only, please refer to the German original.