BioCentury
ARTICLE | Clinical News

Esbriet pirfenidone regulatory update

December 3, 2012 8:00 AM UTC

The U.K.'s NICE issued draft guidance recommending against Esbriet pirfenidone from InterMune to treat mild to moderate idiopathic pulmonary fibrosis (IPF). The committee said Esbriet had a "modest but measurable effect" on slowing decline in lung function, but said there are "uncertainties" over the drug's long-term clinical benefit and its ability to improve overall survival. NICE said the most plausible incremental cost-effectiveness ratio (ICER) for Esbriet would be greater than £36,300 ($58,098) per quality-adjusted life year (QALY) gained, which is above the range considered cost-effective. The committee also said Esbriet did not meet the criteria for a life-extending, end-of-life treatment. Comments are due Dec. 19, with a second appraisal committee meeting scheduled for Jan. 29, 2013. ...