Trifarotene in moderate acne: No study data for the assessment of the added benefit

As the drug manufacturer's dossier did not contain any study data suitable for a direct or indirect comparison with this appropriate comparator therapy, it was concluded that an added benefit of trifarotene is not proven.

Placebo-controlled approval studies

The manufacturer cited two randomized controlled trials from the approval process in which trifarotene was compared with placebo, so they cannot be used for comparison with an established treatment alternative. In addition, the treatment phases of 12 weeks were very short. For a chronic condition like acne vulgaris, a minimum of 24 weeks is needed for a benefit assessment. The dossier contained supplementary information on a 1-year study, but this study had no control arm.

Enough affected people for good comparative studies

According to the manufacturer, there are about one to two million people with moderate acne vulgaris in Germany alone. Katharina Biester from IQWiG's Drug Assessment Department is critical of the fact that, even in such a widespread therapeutic indication, the approval studies were again only carried out in comparison with placebo: "There is a declared political will in Europe to generate evidence for comparisons between drugs. One wonders, therefore, why development programmes for new drugs are not aimed at answering both the questions of the approval and those of the benefit assessment."

G-BA decides on the extent of added benefit

The 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.