Faricimab Eye Treatment: German Review Raises Concerns
The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed a review of the eye treatment faricimab, approved in Europe as July 2024 for macular edema related too retinal vein occlusion.The results? The agency found insufficient evidence to support claims that faricimab offers any meaningful advantage over existing treatments like ranibizumab or aflibercept.
The manufacturer submitted data from two clinical trials, BALATON and COMINO, comparing faricimab to aflibercept. However, the IQWiG persistent that the treatment regimens in these trials didn’t align with the drug’s official guidelines. Patients continued receiving treatment even when their condition stabilized, preventing a proper assessment of faricimab’s true added benefit.
The issue lies in the treatment protocols. The Summary of Product Characteristics recommends initial treatment every four weeks, possibly followed by more frequent monthly injections. After that, the dosage should be adjusted based on individual patient needs, a method known as “treat-and-extend.” The IQWiG noted that a considerable number of patients in the BALATON and COMINO trials reached a stable condition within 8 to 12 weeks. Though, the studies only allowed for individualized dosing adjustments after week 24, a point where all patients were already receiving faricimab. This lack of a true comparison of individualized dosing regimens between faricimab and aflibercept rendered the studies inconclusive.
The European Medicines Agency (EMA) had previously advised the manufacturer to conduct trials using the recommended treat-and-extend approach in both treatment groups.this advice, though, was not followed.
G-BA to Decide on Added Benefit
The IQWiG’s assessment is part of an early benefit assessment process under Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG),overseen by the Federal Joint Committee (G-BA). following this initial review, the G-BA will open a public comment period before making a final determination on whether faricimab provides any added benefit to patients.
This review highlights the importance of rigorous clinical trials that accurately reflect real-world treatment practices. The findings raise questions about the efficacy of faricimab and underscore the need for transparent and comprehensive data in the evaluation of new medical treatments.The G-BA’s final decision will have significant implications for patient access to this new eye treatment in Germany and could influence regulatory decisions in other countries.
Faricimab for Retinal Vein Occlusion: German Review Sparks Debate Among Experts
A recent review by the German Institute for Quality and Efficiency in Health Care (IQWiG) has raised concerns about the efficacy of the new eye treatment Faricimab for macular edema related to retinal vein occlusion. World-Today-News.com Senior Editor, Maria Lopez, spoke with Dr. Stefan Schmidt, an ophthalmologist and retinal specialist, to get his outlook on this developing story.
Maria Lopez: Dr.Schmidt, thank you for joining us. The IQWiG review found insufficient evidence to support claims that Faricimab offers any meaningful advantage over existing treatments for macular edema. Can you elaborate what this means for patients?
Dr. Stefan Schmidt: Thanks for having me, Maria. It’s an crucial topic. Essentially, the review suggests that the clinical trials submitted for Faricimab approval may not have accurately reflected real-world treatment practices. The trials’ designs, specifically regarding dosage regimens, didn’t align with the recommended ”treat-and-extend” approach.
Maria Lopez: Can you explain the importance of the “treat-and-extend” approach for &[this condition] ?
Dr.Stefan Schmidt: Absolutely. In the “treat-and-extend” approach, the treatment frequency is individualized based on a patient’s response. Onc their condition stabilizes, injections are spaced out. This can lead to fewer injections overall and potentially fewer side effects.
Maria Lopez: and how did this factor into the IQWiG’s concerns about the Faricimab clinical trials?
Dr. Stefan Schmidt: Well, the trials continued treatment even when patients reached a stable condition. This didn’t allow for a true comparison of the “treat-and-extend” approach with Faricimab versus existing treatments. It makes it hard to say definitively if faricimab offers any real added benefit in a practical setting.
Maria Lopez: The article mentioned that the European medicines Agency (EMA) had recommended the “treat-and-extend” approach for these trials.Why wasn’t this advice followed?
Dr. Stefan Schmidt: That’s a good question and one that’s likely to be debated. We don’t have a definitive answer yet. Sadly, pharmaceutical companies sometimes prioritize speedy approvals over long-term studies that may reveal more nuanced results.
Maria Lopez: What’s going to happen now? What are the next steps in this process?
Dr. Stefan Schmidt: The Federal Joint Committee (G-BA) in Germany will now review the IQWiG’s findings and open a public comment period. They’ll ultimately decide if Faricimab offers a proven added benefit. This decision will have significant implications for patient access to this treatment in Germany and could influence other countries’ regulatory decisions.
