G-BA assessments of new indications

The AMNOG law dictates that every pharmaceutical product with a new chemical entity which received its marketing authorization on or after 1 January 2011 is subject to a benefit assessment in Germany.

In addition, new indications of products that were first approved on or after 1 January 2011 are also assessed by the G-BA.

That means new indications of products that were first approved before 1 January 2011 are not assessed by the G-BA.

There first was an attempt to gradually assess all products that were approved before the cut-off (= called “Bestandsmarkt”) as well, but this idea was abandoned in April 2014.

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