BioCentury
ARTICLE | Regulation

Flexing AMNOG

Germany's G-BA showing some flexibility in AMNOG drug pricing law

April 9, 2012 7:00 AM UTC

Following an outcry over its assessments of Orphan drugs and complaints about the comparators used to assess the benefits of new drugs, the German Federal Joint Committee (G-BA) is signaling a willingness to adapt. Just how much is unclear.

A key change - confirmed at a closed door meeting on March 22 to review implementation of the country's new AMNOG drug pricing law - is that sponsors of new Orphan drugs will be exempted from a benefit assessment until annual sales to the German healthcare system hit €50 million...