11.12.2010

German Bundestag approves AMNOG - end of free pricing

The German Bundestag approved yesterday the new health bill AMNOG (known as Arzneimittelmarkt-Neuordnungsgesetz). This is a significant change for the introduction of drugs in Germany. Among other measures it ends the period of free pricing in Germany and secondly it introduces the concept of benefit/cost assessments into Germany after all.
Health minister Philipp Roesler said the law will create the right balance between granting access to new drugs and controlling costs. "We don't want drugs to be more expensive in Germany than elsewhere," he added.
The magic bullet control drug prices in Germany is supposed to be an early benefit assessment conducted by IQWIG - methodological details not yet fully known. The law maintains free pricing in the first year of the product launch but imposes a benefit assessment of new drugs within three months of commercialization in order to set a price as of the 13th month of sales. Drugs evaluated as of additional value are allowed to negotiate price setting with the statutory health insurance funds while those deemed as of no added value will be automatically included in Germany's therapeutic reference pricing system.
A lot will therefore depend as to how the benefit assessment will be conducted but first indications in the area of oncology (although IQWIG has not yet evaluated cancer drugs) where apparently overall survival is deemed the only acceptable endpoint, indicates that the institute might take a strong stand on the assessment of benefits.
Germany is in for an interesting ride but also significant EU wide implications can be expected from the new price setting process and results.
We count on readers from Germany to keep us up to date.
A cynical few might be that pricing and health economics professionals will now experience a golden professional future in Germany ...
Cheers
Ulf

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