Aflibercept (1) – Eylea®

• Clinical trials
  • In the RCTs described in the dossier (VIEW 1 and VIEW 2), ranibizumab was not administered in accordance with its current marketing authorisation status, but was administered monthly, regardless of whether visual acuity had remained stable at three consecutive monthly check-ups and whether, according to the marketing authorisation, the medication should have been suspended.

Patients with neovascular (wet) age-related macular degeneration (AMD)

• The additional benefit compared with the appropriate comparator therapy is not proven.
• The G-BA notes that, in the dossier submitted for the benefit assessment of aflibercept, the pharmaceutical manufacturer has not demonstrated or substantiated, in a manner compliant with statutory and subordinate legal requirements, that aflibercept offers additional benefit over the appropriate comparator therapy specified by the G-BA.
• The dossier does not include any direct comparative studies of aflibercept versus the appropriate comparator therapy as specified in the marketing authorisation.
• Nor is the so-called ‘best available evidence’ presented in the dossier suitable for answering the question at hand, as the ‘descriptive indirect comparison’ carried out by the pharmaceutical manufacturer does not meet the requirements for an adjusted indirect comparison.
• The documents submitted with the dossier are therefore insufficient to provide proof of additional benefit compared with the appropriate comparator therapy.
• Consequently, the additional benefit of aflibercept compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.