Off-Label-Use

In the area of the medication ordinance for statutory health insurance patients, physicians do not have much room for manoeuvre due to the specifications in the approval. The statutory health insurance funds will only cover the costs if the drug has been approved both for its intended use and for this treatment. Thanks to medical studies, however, there have also been areas of application that optimally support a treatment for which no AMG approval has been obtained. For such so-called off-label applications, the costs are usually not covered. However, the social courts have defined exceptions to this. This Master's thesis describes the development of these jurisdictions and also refers to the constitutional requirements. Comparative to this, the regulation according to AMG is explained again and again. Finally, recommendations for action for the prescribing Ä.