As of July 2024, faricimab has also been approved in Europe for the treatment of vision impairment due to macular edema due to retinal vein occlusion. The German Institute for Quality and Efficiency in Healthcare (IQWiG) has now examined in an early benefit assessment whether faricimab offers patients benefits over ranibizumab or aflibercept. However, the manufacturer of the drug did not present appropriate data. Therefore, there was no evidence of additional benefit of faricimab over comparator treatments.
The manufacturer submitted the results of the completed RCTs (randomized controlled trials) BALATON and COMINO, which compared faricimab and aflibercept with each other, with its dossier. However, the treatment regimens in both studies did not meet the specifications of the Summary of Product Characteristics: Patients continued to receive treatment even if the findings were stable and it was not possible to individualize the dosing regimens in the phase of the study in which faricimab was compared with aflibercept. Therefore, the studies were underpowered to assess benefit.
Background: According to the respective Summary of Product Characteristics, treatment with faricimab or aflibercept should initially be given every four weeks, possibly requiring three or more consecutive monthly injections. Treatment should then be individually adjusted according to a treatment and extension dosage regimen depending on disease activity. The data, e.g. for best-corrected visual acuity, show that a large proportion of patients in the BALATON and COMINO studies had stabilized after only 8 to 12 weeks. However, according to the study design, individual adjustment of the dosing regimen was possible only in the second, non-comparative half of the study from Week 24, in which all patients were also treated with faricimab. Consequently, a relevant proportion of patients continued to be treated with an unchanged regimen despite consistent findings, and no data are available comparing individualized dosing regimens of faricimab and aflibercept.
According to the European Public Assessment Report, the European Medicines Agency (EMA) had explicitly recommended to the manufacturer, as part of its consultation, to create a study with a treatment and extension dosing regimen in both study arms. The manufacturer did not follow this recommendation.
The TALON RCT, comparing brolucizumab and aflibercept for the treatment of neovascular (wet) age-related macular degeneration, shows there is another way. In the TALON study, a treat-and-extend regimen is used in both arms, allowing for individualized treatment intervals for each patient based on disease activity. Therefore, the study was suitable for early evaluation of the benefit of the drug brolucizumab, which was conducted in early 2024.
The G-BA decides on the extent of the additional benefit
The dossier assessment is part of the early benefit assessment under the Medicines Market Reform Act (AMNOG) overseen by the G-BA. After the dossier evaluation is published, G-BA conducts a comment process and makes a final decision on the extent of the additional benefit.
