Added benefit of aflibercept not proven in myopic choroidal neovascularisation

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Aflibercept (trade name: Eylea) has been approved since October 2015 for adults with impaired vision due to myopic choroidal neovascularisation.

The drug has already undergone several early benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG) for other therapeutic indications. The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to conduct a dossier assessment also for the new therapeutic indication. Since the manufacturer cited no suitable studies in its dossier, an added benefit of aflibercept in comparison with the appropriate comparator therapy is not proven.

Drug is used to inhibit neovascularization in the eye

In short-sightedness, also called myopia, the eyeball has grown too long. This may cause tears in the membrane between choroid and retina that stimulate the growth of blood vessels, i.e. neovascularization, in the choroid. If the vessels grow into the retina and start leaking, this may additionally impair visual acuity and, in the worst case, cause blindness. Drugs are injected into the eyeball to inhibit this neovascularization.

No studies on the comparison with ranibizumab

According to the G-BA, for this therapeutic indication aflibercept was to be compared with ranibizumab, a monoclonal antibody also used to inhibit neovascularization. Since the manufacturer presented no studies on this comparison in its dossier, an added benefit of aflibercept in comparison with the appropriate comparator therapy for patients with myopic choroidal neovascularization is not proven. This result concurs with that of the manufacturer.

G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to AMNOG supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the Website, published by IQWiG, provides easily understandable German-language Information.


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