Monday, June 10, 2013

Ammendment to ease AMNOG comparator rules passed

The German Bundestag (lower house parliament) has recently approved an amendment to  AMNOG (known as Arzneimittelmarkt-Neuordnungsgesetz). The bill intends to  ease the stringent comparator rules that are used to determine the price of  a novel drugs in Germany. AMNOG was introduced  in Germany in 2010 and it brought an  end to the period of free pricing in Germany and  introduced the concept of benefit/cost assessments to price drugs.
The amendment would eliminate the requirement for Germany's Federal Joint Committee (G-BA) to conduct benefit assessments of new therapies vs. the lowest-cost alternative. The bill is expected to go to Germany's upper house (Bundesrat) on July 5. If the Bundesrat does not object, it will pass into law. If the Bundesrat objects, the bill will be sent to arbitration.  However lately AMNOG came under severe criticism, as it had



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