Apremilast in plaque psoriasis and psoriatic arthritis: No added benefit can be derived

Manufacturer itself did not claim an added benefit

The drug manufacturer presented no studies in which apremilast was tested against the respective appropriate comparator therapy for any of the two therapeutic indications. It only described data from placebo-controlled studies, but did not use them for indirect comparisons.

There was also no systematic search for studies with the appropriate comparator therapy, which might be suitable for an indirect comparison with apremilast. It therefore remains unclear whether an indirect comparison would have been possible and whether this comparison would have shown an added benefit or lesser benefit of apremilast in comparison with the drugs already available. Consistently, the manufacturer itself did not claim an added benefit for the new drug in any of the two therapeutic indications.

G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (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 gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language Information.