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April 5, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today reported that the Transparency Commission (CT: Commission de Transparence) of the French National Health Authority (HAS: Haute Autorite de Sante) has issued a favorable opinion for the reimbursement of Esbriet® (pirfenidone) by French National Health Insurance.
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. ASMR 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.
The CT has recommended that Esbriet be reimbursed as a "medicament d'exception", which means that it will be reimbursed only for the labeled indication, further defined by the CT as IPF patients with forced vital capacity (FVC)
> 50% and DLco
> 35%. The CT also recommended that InterMune collect information in the form of a patient registry regarding the use of Esbriet in clinical practice. InterMune will now enter the next step in the process, which is to determine the price and any reimbursement conditions of Esbriet in
France with the CEPS (Comite Economique des Produits de Sante).
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are pleased to receive the CT's favorable opinion for reimbursement of Esbriet. In the recently more challenging market access environment in
France, our rating of ASMR IV is a positive outcome for Esbriet. The SMR and ASMR ratings we secured for Esbriet allow us to advance to the next step in the French process and we are optimistic about successfully concluding negotiations with the CEPS and making Esbriet available to patients in
France as soon as possible and practical thereafter."
Based on information published on the HAS website, since early 2011 the CT did not recommend reimbursement in 32% of all its new product appraisals, compared with an historic average of 4%.