Amendment could ease AMNOG comparator rules

The lower house of German Parliament (Bundestag) will vote Thursday on a bill that includes an amendment that 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 amendment states that additional benefit could be demonstrated over any "appropriate" comparator and specifies that appropriate comparators should be determined according to regulations on the implementation of AMNOG that were issued by lawmakers in December 2010. Those regulations call for comparators to be determined based on "international standards of evidence-based medicine" for a given indication.

In a written explanation of the changes that accompanies the text of the amendment, the authors said the choice of comparator would now be "left to the company." ...