There is no evidence of additional benefit of faricimab compared to comparator therapies for the treatment of macular edema

As of July 2024, faricimab is also approved in Europe for the treatment of visual disturbances caused by macular edema secondary to retinal vein occlusion. The German Institute for Healthcare Quality and Efficiency (IQWiG) has now investigated whether faricimab provides benefits to patients compared to ranibizumab or aflibercept as part of an early benefit assessment. However, the drug manufacturer did not provide any relevant data. Therefore, there was no evidence of additional benefit of faricimab compared to comparator therapies.

The manufacturer presented in its documentation the results of completed RCTs (randomized, controlled trials) BALATON and COMINO, in which faricimab and aflibercept were compared. However, the treatment regimens in both studies did not meet the specifications in the Summary of Product Characteristics: Patients continued treatment even though results were stable and it was not possible to individualize dosing regimens during the faricimab versus aflibercept phase of the study. Therefore, the studies were not suitable for assessing benefits.

Background: According to the relevant Summary of Product Characteristics, treatment with faricimab or aflibercept should initially be administered every four weeks, with three or more subsequent monthly injections likely to be required. Treatment should then be individualized according to a “treat and expand” dosing regimen depending on disease activity. Data, e.g. regarding best-corrected visual acuity, show that a large proportion of patients in the BALATON and COMINO studies achieved stabilization after 8–12 weeks. However, consistent with the study design, individual adjustments to the dosing regimen were only possible in the second, noncomparative half of the study at week 24, in which all patients also received faricimab. Therefore, an appropriate proportion of patients continued to be treated with an unchanged treatment regimen despite stable treatment outcomes and no data are available on the comparison of individualized faricimab and aflibercept dosing regimens.

According to the European Public Assessment Report, the European Medicines Agency (EMA) specifically recommended to the manufacturer in its consultation that the study be conducted with a ‘treat and extend’ dosing regimen in both arms of the study. The manufacturer did not follow this recommendation.

The TALON RCT that compares brolucizumab and aflibercept in the treatment of neovascular (wet) age-related macular degenerationshows that there is another way. In the TALON trial, both treatment arms use a treatment and extension regimen, which allows for individual adjustment of treatment intervals for each patient depending on disease activity. The study was therefore suitable for an early assessment of the benefits of brolucizumab, which was conducted in early 2024.

G-BA decides on the scope of the additional benefit

The dossier assessment is part of an earlier benefit assessment under the Medicinal Market Reform Act (AMNOG), overseen by the G-BA. Once the dossier assessment has been published, the G-BA conducts a comment procedure and makes a final decision on the scope of the additional benefit.