IQWIG Publishes Early Benefit Assessment for Pirfenidone
InterMune, Inc. (NASDAQ: ITMN) today reported that the private Institute for Quality and Efficiency in Health Care has today published its report on the benefit assessment of Esbriet® (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis. Pirfenidone is the first Orphan Drug to be reviewed by IQWiG since new healthcare legislation known as AMNOG was enacted in January of 2011.
Despite its approval by the EU regulatory authorities, IQWiG concluded that no additional benefit could be found for pirfenidone. However, by German law Orphan Drugs are deemed as having an additional benefit, leading IQWiG to assess the Esbriet additional benefit as given but not quantifiable. The company has a number of important concerns with the methodology applied by IQWiG and plans to vigorously challenge the IQWiG assessment during the 90-day review period that has now begun.
