AMNOG

AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) is the German law that requires every new drug to go through an early benefit assessment within months of launch. The G-BA defines the appropriate comparator; IQWiG reviews your dossier; the resulting added-benefit rating drives the price negotiation with the GKV-SV. Get the comparator wrong and the rest of the dossier doesn't matter.

In practice, AMNOG is won or lost in the first 90 days — comparator alignment, endpoint selection, and the way you frame subgroup analyses against the G-BA's expectations.