AMNOG
Germany's post-launch benefit assessment.
Germany's Arzneimittelmarkt-Neuordnungsgesetz — the post-launch benefit assessment that decides the price your asset can defend in Europe's largest market.
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.
The first 90 days after a positive opinion decide whether you fight from the front foot or spend a year defending claims you never should have made. Here is how the winning teams sequence them.
A working guide to compressing market access strategy onto a single page — the only version that gets read across Medical, HEOR, Commercial and the launch committee.
A practical week-by-week breakdown of the AMNOG process — what the G-BA reads first, when IQWiG enters, and where senior reviewers fix problems before they become objections.