Remimazolam (2) – Byfavo®

• Clinical trials
  • The pharmaceutical manufacturer identifies, within the present therapeutic indication, the studies CNS7056-011, CNS7056-022 and ONO-2745-05, which compared remimazolam with propofol, and the study CNS7056-010, which compared propofol for induction and sevoflurane for maintenance of anaesthesia in the control arm.

Adults requiring general anaesthesia

• An additional benefit is not proven.
• Overall, additional benefit is not proven for remimazolam for the intravenous induction and maintenance of general anaesthesia in adults.
• The pharmaceutical manufacturer has not provided any data to assess the additional benefit of remimazolam compared with the appropriate comparator therapy.
• Within the current therapeutic indication, the marketing authorisation holder identifies the studies CNS7056-011, CNS7056-022 and ONO-2745-05, which compare remimazolam with propofol, and study CNS7056-010, in which propofol was used for induction and sevoflurane for maintenance of anaesthesia in the comparator arm.
• The pharmaceutical manufacturer presents the studies CNS7056-022 and ONO-2745-05 in the dossier, but does not analyse the results as part of the benefit assessment.
• The pharmaceutical manufacturer considers the studies it has identified as supporting the marketing authorisation to be unsuitable for the benefit assessment.
• It justifies this on the grounds that in none of the marketing authorisation studies was individualised therapy employed involving the selection of propofol, etomidate and thiopental (for induction of anaesthesia) or of propofol, isoflurane, desflurane and sevoflurane (for maintenance of anaesthesia).
• However, the active ingredients propofol and sevoflurane are specified options within the context of individualised therapy.
• The authorisation studies could therefore provide evidence for those patients for whom Propofol or Sevofluran constitutes a suitable treatment.
• For these patient populations, however, the pharmaceutical manufacturer has not submitted any processed data, either in the dossier or during the commenting procedure.
• Overall, it can be concluded that the studies supporting the marketing authorisation contain potentially suitable data for the benefit assessment of remimazolam compared with propofol or sevoflurane.
• In addition, the IQWiG has identified further studies relevant to the benefit assessment that contain potentially suitable data on remimazolam compared with propofol.
• The pharmaceutical manufacturer has not submitted these study results either.

Courtesy translation only, please refer to the German original.