OBJECTIVES: The EU Regulation No. 1394/2007 of the European Parliament and the Council on ATMP defines all medicinal products based on gene therapy, somatic-cell therapy or tissue engineering launched in Germany since 2007 as drugs. Therefore, ATMPs should fall under the AMNOG process acc. to §35a SGBV – or be exempted from it. The objective of this study is to assess how ATMP products have been evaluated by the German Federal Joint committee (Gemeinsamer Bundesausschuss – G-BA) and what the consequences for the market access of the evaluated products were.

METHODS: All ATMP products registered between 01.01.2009 and 22.06.2017 which have a centralized international (through EMA) or a national market authorization in Germany have been analyzed to understand (1) how many ATMP products went through a regular drug evaluation (AMNOG)? (2) In how many cases has the G-BA decided to use a different way of assessment and what does the process of evaluation mean for the market access of those products in Germany?

RESULTS: CONCLUSIONS: Though the EU regulation defines products based on gene therapy, somatic-cell therapy or tissue engineering as drugs, the market access process in Germany follows only in some cases the specific drug procedures for new drug products, the AMNOG process.