Germany to stop assessments of pre-AMNOG drugs

German politicians agreed to eliminate benefit assessments of drugs that were launched before January 2011, when drug pricing law AMNOG came into effect, and instead agreed to continue the country's drug pricing freeze and mandatory rebates. The measure was agreed upon on Monday during coalition talks to form a new government in Germany. According to a person familiar with the matter, once the new government is formed the change would need to be implemented legislatively, which is unlikely to occur before the existing pricing freeze -- which set drug prices at 2009 levels -- and 16% mandatory rebates expire at year end. The change is expected to be implemented "relatively quickly" in January and will likely be effective retroactively. Under the agreement, the mandatory rebates would be lowered to 7% and the German government would revisit the pricing freeze and rebates in 2015.

According to the person familiar with the agreement, assessments of drugs launched prior to January 2011 -- when AMNOG took effect -- are likely to be invalidated. Germany's Federal Joint Commission (G-BA) has completed assessments of several dipeptidyl peptidase-4 (DPP-4) inhibitors and is currently assessing pre-AMNOG drugs including osteoporosis treatment Prolia denosumab from Amgen Inc. (NASDAQ:AMGN). ...