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Jan 30, 2012
 |  BioCentury  |  Regulation

AMNOG's uncharted waters

How AMNOG pricing may work for mixed-benefit drugs in Germany

The authors of AMNOG, Germany's new drug pricing law, evidently didn't consider what to do when a drug shows benefit in some patient subgroups but not in others. These drugs, which are rapidly becoming the norm, don't fit into either of the scheme's two categories: premium priced or reference priced.

Hints about how Germany will handle the pricing of so-called mixed-benefit drugs could come in the next six months, when AstraZeneca plc wraps up its pricing negotiations for Brilique ticagrelor to prevent atherothrombotic events in acute coronary syndrome (ACS) patients.

European commercial consultants contacted by BioCentury think such drugs will end up with a blended price negotiated with the authorities.

Under AMNOG, when a company launches a new drug, it can set its own price but must also submit a dossier of clinical evidence to the German Federal Joint Committee (G-BA), comparing the drug with another treatment. If G-BA determines the product provides a benefit over the comparator, the company negotiates the price with the Statutory Health Insurance Funds Association (GKV-Spitzenverband). Drugs deemed to show no additional benefit receive a reference price with no opportunity to negotiate (see BioCentury, Sept. 19, 2011).

The law came into effect in January 2011, and assessments have already come under fire for the way comparator drugs are chosen and for how Orphan drugs are treated.

Last September, partners Boehringer Ingelheim GmbH and Eli Lilly and Co. decided not to launch diabetes drug Trajenta linagliptin in...

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