The plan lowers the evidence bar at launch and moves the proof to later real-world data, where insurers doubt it exists.

Germany’s health ministry has presented key points for an AMNOG 2.0, the first overhaul of its drug benefit assessment since 2011, at a session of the government’s Pharmadialog, Ärzte Zeitung reported on 28 September 2026.
Best available evidence would be enough to establish added benefit in 5 regulatory situations: conditional approval, accelerated assessment, exceptional circumstances, PRIME and orphan drugs. Drugs would be re-evaluated 3 to 4 years after their first assessment, mainly on data from the national Health Research Data Centre, with added benefit confirmed, adjusted or revoked, and prices renegotiated if revoked.
The GKV-Spitzenverband, the statutory insurers’ federation, says about 60% of approvals would fall under the new rules and calls it a break with the system. The industry association vfa says that figure double counts overlapping categories, and puts the share at under 10% a year outside existing orphan rules.
Application-accompanying data collection would be abolished, and the orphan drug privilege left unchanged for now. Orphan drugs account for 0.1% of statutory prescription volume but almost 13% of revenue, according to figures cited by Ärzte Zeitung.

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The proposal lowers the evidence bar at launch and moves the proof to later real-world data, which is where insurers doubt it can be found.

Regulatory route would set the evidence standard. All five categories are defined by EMA procedures, so two similar drugs could be assessed differently because of how they were approved. For sponsors, PRIME or conditional approval would carry German pricing value. Nezglyal, approved in the EU under exceptional circumstances last week with a German launch planned by year end, is exactly the kind of product in scope.
60% against 10% is a counting dispute with a budget attached. Approval routes overlap, and which share is right determines how much spending the change moves. Until the ministry publishes a draft bill, both numbers are advocacy.
A German price now travels. The vfa warns that US most-favoured-nation pricing already hinders German launches, and Germany is one of the eight countries in Lilly’s MFN basket with HHS. Any higher launch price AMNOG 2.0 allows would feed into US reference calculations.

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Germany’s AMNOG 2.0 Would Accept Best-Available Evidence for Five Approval Types, and Insurers Say 60% Qualify