OBJECTIVES: Personalized medicine has made it possible to identify patients for whom therapy with a particular drug is effective. However, pharmaceutical companies are also facing the so-called "fourth hurdle" with their approved drugs, as the evaluation of new drugs in Germany has been regulated by the AMNOG since 2011. The goal of AMNOG in Germany is to regulate the balance between innovation and affordability of medicines due to growing drug expenditures. For this reason, a comparative analysis of the market penetration of personalized medicine drugs is carried out under the conditions of AMNOG in order to derive possible opportunities and risks for personalized medicine drugs.

METHODS: Personalized medicine drugs that already underwent the AMNOG procedure are used for the evaluation. The available procedural documents were used to evaluate the early benefit assessment. In addition, the market penetration of drugs of personalized medicine is analyzed in comparison to other active substances evaluated during AMNOG on the basis of prescription data taken from the IMS PharmaScope^® database.

RESULTS: Altogether, n= 54 (personalized medicine=19, other =35) products were included in the analysis. 70% of the evaluated drugs of personalized medicine were evaluated with an additional benefit, being a higher rate than for other benefit assessments. The market penetration of personalized medicine drugs under the conditions of AMNOG was particularly successful in oncological diseases. Oncological drugs for personalized medicine achieved an average market penetration of 25% for non-orphans and 28% for orphan drugs.

CONCLUSIONS: Due to the small number of products no generally valid statements can be made. Further analyses, for example on price trends, could provide further information.