Trifarotene is a drug for the external treatment of acne vulgaris of the face and trunk. It is suitable for affected people with many comedones, papules and pustules, i.e. with moderate acne for which systemic therapy is not yet an option. The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to investigate whether the drug offers these patients aged twelve years and older an added benefit in comparison with combination therapy of adapalene and benzoyl peroxide or of clindamycin and benzoyl peroxide, which is also applied externally.
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.
More English-language information will be available soon (Sections 2.1 to 2.5 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to firstname.lastname@example.org.