Since July 2024, faricimab has additionally been accredited in Europe for the therapy of visible impairment attributable to macular oedema secondary to retinal vein occlusion. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined in an early profit evaluation whether or not faricimab gives sufferers advantages over ranibizumab or aflibercept. However, the drug producer didn’t current any appropriate knowledge. Consequently, there was no proof of an added good thing about faricimab versus the comparator therapies.
The producer submitted the outcomes of the finished RCTs (randomized managed trials) BALATON and COMINO, which in contrast faricimab and aflibercept with one another, with its file. However, the therapy regimens in each research didn’t correspond to the specs of the Summary of Product Characteristics: Patients continued to be handled even when the findings have been steady, and it was not doable to individualize the dosing regimens within the research section by which faricimab was in contrast with aflibercept. Thus, the research have been unsuitable for the profit evaluation.
Background: According to the respective Summary of Product Characteristics, therapy with faricimab or aflibercept ought to initially be carried out each 4 weeks, with three or extra consecutive month-to-month injections probably being required. Subsequently, therapy ought to be adjusted individually in accordance with a treat-and-extend dosing routine relying on the illness exercise. The knowledge, e.g. on finest corrected visible acuity, present that a big proportion of sufferers within the research BALATON and COMINO had stabilized after simply 8 to 12 weeks. However, in accordance with the research design, particular person adjustment of the dosing routine was solely doable within the second, non-comparative half of the research from Week 24, by which all sufferers additionally acquired therapy with faricimab. Accordingly, a related proportion of sufferers continued to be handled with an unchanged therapy routine regardless of steady findings, and no knowledge can be found on a comparability of individualized dosing regimens of faricimab and aflibercept.
According to the European Public Assessment Report, the European Medicines Agency (EMA) had explicitly advisable to the producer as a part of its session {that a} research with a treat-and-extend dosing routine be arrange in each research arms. The producer didn’t observe this suggestion.
The RCT TALON, which compares brolucizumab and aflibercept for the therapy of neovascular (moist) age-related macular degeneration, exhibits that there’s one other approach. In the TALON research, a treat-and-extend routine is utilized in each arms, which permits a person adjustment of the therapy intervals for every affected person relying on the illness exercise. The research was subsequently appropriate for the early profit evaluation of the drug brolucizumab, which was carried out in early 2024.
The G-BA decides on the extent of additional advantage
The file evaluation is a part of the early profit evaluation in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the file evaluation, the G-BA conducts a commenting process and makes a last determination on the extent of the additional benefit.