Aflibercept (4) – Eylea®

Macular edema following retinal branch vein occlusion

Characteristics

Start date 15.03.2015
Resolution 03.09.2015
INN Aflibercept
Brand name Eylea®
Pharm. company Bayer Vital GmbH
G-BA Procedure ID D-160
ATC code S01LA05 Antineovascularisation agents (S01LA)
ICD-10 codes (AIS) H34.8Other retinal vascular occlusions, H35.8Other specified retinal disorders
Alpha-ID codes (AIS) I10546Macular edema, I108797Branch retinal vein occlusion
DDD 20 mg P
Therapeutic area Eye diseases Macular edema
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Eylea is indicated for adults for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)

 
Subpopulation Indication Comparator
Adult patients with visual impairment due to macular edema resulting from retinal branch retinal vein occlusion. Ranibizumab

Studies and Results

No. of studies
(best subpopulation) 		1 (VIBRANT)
Study design
(best subpopulation) 		H2H vs. non-ACT + no ITC
Meta analysis
(best subpopulation) 		no
ACT change 18.08.2015 – nach Dossiereinreichung im Stellungnahmeverfahren

  • Clinical trials
    • The VIBRANT trial was the registration trial for aflibercept in the indicated therapeutic indication.
    • A total of 91 patients were randomised to receive aflibercept and 92 patients to GRID laser therapy.

Patients with impaired visual acuity due to macular oedema resulting from a retinal vein branch occlusion (RVBO)

  • For patients with impaired visual acuity due to macular oedema resulting from retinal vein branch occlusion, additional benefit is not proven.
  • The study submitted by the pharmaceutical manufacturer is not suitable for assessing the additional benefit of aflibercept compared with the G-BA’s appropriate comparator therapy.
  • This is because aflibercept was used in a manner deviating from the authorised treatment regimen and the G-BA’s appropriate comparator therapy was not implemented in the study.
  • No study has been identified that directly compares aflibercept with ranibizumab.
  • On the basis of the information in the dossier, the IQWiG’s benefit assessment and the comments on the benefit assessment, the G-BA concludes that the additional benefit of aflibercept over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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