Impact of the Early Benefit Assessment on A Pharmaceutical's Real Consumption in Germany.

The Act on the Reform of the Market for Medicinal Products (“AMNOG”) introduced an early benefit assessment (EBA) of pharmaceuticals in Germany in 2011. According to this law, all pharmaceuticals with a new active agent made available on the market for the first time have to go through a benefit assessment process. A benefit assessment dossier has to be submitted at the time of the market entry of the new pharmaceutical. In this benefit assessment dossier, the pharmaceutical company has to prove the additional benefit of the pharmaceutical compared to a given appropriate comparator. Since the impact of the EBA results on a pharmaceutical’s consumption is unclear, those effects were quantitatively analyzed. Methods