Dossiers contained neither studies of direct comparisons nor indirect comparisons
Apremilast (trade name: Otezla) has been available since January 2015 for the treatment of moderate to severe plaque psoriasis or active psoriatic arthritis in adult patients in whom certain pretreatments are not sufficiently effective or unsuitable. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in two dossier assessments whether this drug offers an added benefit over the respective appropriate comparator therapy. Such an added benefit cannot be derived from any of the dossiers however, because they contain no relevant data.
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.