French Transparency Commission issues favorable opinion on Esbriet

There was good news last week for USA-based InterMune (Nasdaq: ITMN) when the Transparency Commission (CT: Commission de Transparence) of the French National Health Authority (HAS: Haute Autorite de Sante) issued a favorable opinion for the reimbursement of its lung drug Esbriet (pirfenidone) by French National Health Insurance. The news drove the stock 10% to $15.28.

Esbriet is the first-ever drug approved by the European Union regulatory authorities in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF; The Pharma Letter May 17, 2011). The French news follows a recent favorable opinion on Esbriet’s benefits from the German regulatory body the Federal Joint Committee (G-BA; TPL March 16).

The CT noted that no other treatment provided evidence of a clinical benefit in IPF and considering all available information, Esbriet was granted an Amelioration du Service Medical Rendu (ASMR) rating of level IV, which is a rating of added clinical value in comparison with existing therapies. The CT focused on the risk/benefit ratio for assessing the actual medical benefit (Service Medical Rendu - SMR), and rated it as "Low." Patients suffering with severe, chronic diseases in France are typically reimbursed 100% for all services and medicines associated with the management of their condition, regardless of SMR level other than "Insufficient" (under a specific program for such diseases (Affection de Longue Duree - ALD). This program covers more than 8.3 million French citizens.