Client situation
In the approval study, our client had chosen a comparator therapy for their medicinal product that did not correspond to the appropriate comparator therapy defined by the G-BA for the benefit assessment.
Our solution
If the medicinal product to be evaluated has not been compared directly with a specific comparator therapy in studies, an additional benefit compared to the comparator therapy can only be shown by indirect comparison. The method of choice is usually an adjusted indirect comparison via a bridge comparator (Bucher method). We carried out such an indirect comparison for our client after we had identified a suitable study based on a systematic literature search. We were able to prove significant benefits for the client's medicinal product in several endpoint categories.
Client benefits
Like most of the indirect comparisons carried out in the early benefit assessment, the indirect comparison was not accepted by the IQWiG due to the diversity of the study populations. Nevertheless, the indirect comparison helped our client to achieve a positive perception among opinion leaders and in the price negotiations. In addition, the indirect comparison could be published in a scientific journal, thereby supporting the positioning of the product.