AMNOG System

Under Germany’s AMNOG pricing system, all new drugs are freely priced for the first 12 months following launch. However, they must undergo a benefit assessment to determine how much additional benefit they offer compared with comparators already available.

IQWiG conducts the benefit assessment but the G-BA, the most senior federal health care decision-making body in Germany, makes the final decision on the drug’s rating.

Possible ratings include: major benefit, considerable benefit, minor benefit, unquantifiable benefit, no proven benefit, and less benefit than the comparator. These ratings are important as they inform pricing negations between insurers and the pharmaceutical company – the higher the rating, the better chance the company has of securing a better price.

However, there is more flexibility in the system for orphan drugs, which do not have to undergo a full benefit assessment as long as annual sales for the product do not exceed €50m ($55m). The company is not required to provide comparative data and the product is awarded a positive rating of at least “unquantifiable benefit.” If sales do exceed the €50m threshold, the product must undergo a full benefit assessment.

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