Under the Amnog system, a new product is freely priced in Germany for the first six month after launch. However, the product is then evaluated against a comparator already on the market in terms of the additional benefits it offers. The comparator is selected by the G-BA. Possible ratings include: major benefit, considerable benefit, minor benefit, non-quantifiable benefit, no proven benefit, and less benefit than the comparator.

These ratings are important as they influence pricing negotiations between the pharmaceutical company and health insurers represented by the GKV-SV to agree on the size of the discount on the list price that companies will have to give health insurers.

There is a little more flexibility for orphan drugs, which do not have to undergo a full assessment if sales in Germany do not exceed €30m ($32m) a year. Companies with orphans that do not undergo a full assessment do not have to submit comparative data and the product is automatically awarded a rating of at least “non quantifiable benefit.”

Since 2019, the G-BA has been able to mandate the company to collect more data.

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