BioCentury
ARTICLE | Politics & Policy

Germany seeks to prevent AMNOG assessment suits

March 8, 2013 1:37 AM UTC

A draft bill from Germany's Federal Ministry of Health (BMG) that was obtained by BioCentury would clarify language in AMNOG to specify that assessments of drugs marketed prior to January 2011, when the drug pricing law took effect, would be subject to the same regulations as drugs launched after the law took effect. The bill includes language that would explicitly prohibit litigation over benefit assessments of drugs launched before AMNOG came into effect. The law already prohibits litigation over benefit assessments of drugs launched after the law took effect.

Novartis AG (NYSE:NVS; SIX:NOVN) filed a complaint in December seeking to stop the assessment of its Type II diabetes drugs Galvus vildagliptin and Icandra vildagliptin/metformin by Germany's Federal Joint Committee (G-BA). The dipeptidyl peptidase-4 (DPP-4) inhibitors received EU marketing authorization in 2007 and 2008, respectively. A decision on the pending suit is expected in May or June (see BioCentury Extra, Feb. 28). ...