[Consequences of the German AMNOG for the identification of study objectives to demonstrate clinical efficacy and cost effectiveness of innovative drugs].

2011 on drug development are discussed. Assessment criteria for an evaluation of the cost/benefit relationship and on incremental clinical benefit as required by the law were retrospectively applied to those drugs which were approved by the EMA in 2009. On average drugs in comparator arms in development studies were cost effective. In most cases placebo was used as a comparator. Recent examples from the cardiovascular and the oral anti-diabetes areas revealed that the G-BA might go beyond EMA requirements; as a consequence two patent-protected products were withdrawn from the German market following G-BA assessment. Recommendations for future drug development strategies are provided.