Flyer Check, Phase-III Portfolio

5 Explanations Appropriate comparator therapy/comparative intervention Is the therapy whose benefit is compared with the benefit of the drug/medical product being evaluated. The appropriate comparative therapy is to be determined on a regular basis ac- cording to criteria derived from the international standards of evidence - based medicine. If there are several alternatives, the more economical therapy is to be selected, preferably a therapy for which a fixed price applies. The appropriate comparative therapy must be a therapy in the therapeutic area that is appropriate according to the generally accepted state of medical knowledge, preferably a therapy for which endpoint studies are available and which has proven itself in practical use, unless guidelines or the cost effectiveness requirement speak against this. When determining the comparative therapy, the following criteria in particular must be taken into account: Evaluation dimensions / criteria Appropriate comparative therapy  If a drug application is considered as a comparative therapy, the drug must have a marketing authorization for the application area.  If a non - drug treatment is considered as a comparative therapy, it must be available within the framework of GKV.  Preference should be given to drug applications or non - drug treatments whose patient - relevant benefit has already been established by the G - BA.  The comparative therapy should belong to the appropriate therapy in the therapeutic area according to the generally accepted state of medical knowledge.  If there are several alternatives, the more economical therapy is to be selected, prefe- rably a therapy for which a fixed price applies. Unmet Medical Need (UMN) This refers to an unmet medical need. This can initially relate to the available therapy opti- ons, i.e. how well do the available technologies or products cover the medical need. In addi- tion, the therapeutic standard achieved in the target indication can be related to the Unmet Medical Need. For example, a high Unmet Medical Need exists in indications such as cancer, autoimmune diseases or Alzheimer's disease, while a rather low Unmet Medical Need exists in indications such as hypertension or lipid metabolism disorders. A generally high Unmet Medical Need is found in rare and very rare diseases.