AMNOG comparator bill passes Bundesrat
Germany's upper house of Parliament (Bundesrat) on Friday allowed a bill containing an amendment to guidelines implementing drug pricing law AMNOG to pass. The amendment eliminates 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.
The bill must still be signed by Germany's president and will become effective the day after its publication in Germany's Federal Law Gazette, which is expected to occur this month, according to the Association of the German Pharmaceutical Industry (BPI) (see BioCentury Extra, June 7). ...