Esbriet regulatory update

Germany's Federal Joint Committee (G-BA) issued a more favorable assessment of idiopathic pulmonary fibrosis (IPF) drug Esbriet pirfenidone from InterMune than did the Institute for Quality and Efficiency in Health Care (IQWiG). In a final benefit assessment, G-BA said Esbriet provides an additional benefit over best supportive care, but the benefit is not quantifiable. In December, IQWiG said in a preliminary assessment that Esbriet provided no additional benefit. Under Germany's new AMNOG pricing scheme, the medical additional benefit of Orphan drugs is considered to be proven as a result of market authorization (see BioCentury, Dec. 19, 2011).

InterMune said that a non-quantifiable benefit rating means that the drug has an additional benefit that can be defined in the future through daily clinical use or clinical studies. InterMune will now meet with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) to begin pricing negotiations. The company said the negotiations are expected to be completed by Sept. 15; if an agreement cannot be reached by then, negotiations will move to arbitration through an independent third party. ...