InterMune
Inc. is counting on Esbriet pirfenidone's Orphan status to protect the
idiopathic pulmonary fibrosis drug from a drastic price cut despite a negative
review by IQWiG, Germany's health technology assessment agency.
The drug is the first Orphan
product to be reviewed under new regulations in Germany that went into place in
January 2011. The new pricing reform law, known as AMNOG, increased the
required rebates from companies and is designed to save the health system up to
€2 billion ($2.7 billion) per year (see BioCentury,
Sept. 19).