France's Transparency Commission (CT) Issues Favorable Opinion for Reimbursement of Esbriet; Intermune Expresses Confidence In Ascend Phase 3 Study Outcome; Updates Timeline
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).
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