ABSTRACT
The development of ‘personalised medicine’ currently is a widely discussed issue. In particular personalised pharmacotherapy is gaining increasing importance, as a consequence of the developments in the fields of pharmacology and molecular genetics. This requires an examination of the consequences of personalised pharmacotherapy on the German Statutory Health Insurance System (Gesetzliche Krankenversicherung – GKV) and on the quality of patient health care. In this context, a question that arises is the issue of ‘orphanisation’: if personalised medicinal products could regularly be designated as orphan drugs, that is as medicinal products for rare diseases, it would as a general rule not be necessary to provide proof under the Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz – AMNOG) of the additional benefit in the context of the early benefit assessment to be carried out by the German Joint Government Committee (Gemeinsamer Bundesausschuss – G-BA). The decisive aspect for the designation of a medicinal product as an orphan drug is, among others, the prevalence rate of the group of patients whose condition is intended to be treated with the product. In this context, the stratification of patent groups within the framework of personalised pharmacotherapy has particular significance. An ‘orphanisation’ such as this would in particular have price-related consequences for the GKV, due to the lack of knowledge regarding a medicinal product’s additional benefit; for the patients, the consequences must be considered in a more differentiated manner.
