Orphan Benefits – The Facts

Under Germany's AMNOG healthcare reform act, which came into effect in 2011, all new products are freely priced for the first 12 months following launch. Meanwhile, they are evaluated to assess the additional benefits they offer compared to treatments already available. The drug is then awarded a rating based on the additional benefit it is deemed to offer. This rating is then used to inform price negotiations between the manufacturer and the association of statutory sickness funds, the GKV Spitzenverband.

However, the system is more flexible for orphan drugs and automatically acknowledges the product offers some benefit, as long as annual sales do not exceed €50m. These products are automatically awarded a positive benefit rating of at least “unquantifiable benefit.” They do not have to undergo a full benefit assessment and the manufacturer does not have to provide any comparative data, although this changes if annual sales exceed €50m. Under a full assessment, possible ratings are: major benefit, considerable benefit, minor benefit, unquantifiable benefit, no benefit and less benefit.

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