AIFA approves pricing and reimbursement conditions for InterMune's Esbriet

InterMune, Inc. (NASDAQ: ITMN) today announced that the Board of the Italian Drug Agency (AIFA) has approved the pricing and reimbursement conditions for Esbriet^® (pirfenidone), and that the agreement has been published in the Official Gazette, the official journal of the government of Italy. Esbriet is InterMune's product for the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis (IPF). The availability of Esbriet will mark the first time an approved therapy for IPF has been commercially available to the approximately 6,000 to 9,000 mild-to-moderate patients estimated to be living with IPF in Italy. Esbriet will be reimbursed beginning 15 days from the publication date on the Italian Official Gazette, or June 29.

The gross ex-factory price of Esbriet in Italy will be €32,994, or approximately $44,000 per patient, per year.  In addition, pharmaceutical products in Italy are subject to the mandatory national discount of 9.75%.  Reimbursement for Esbriet will be provided under a risk-sharing arrangement, similar to the "Payment for Performance" system already in place for many specialty medicines in Italy. 

Prof. Alberto Pesci, Head of the Pulmonary Clinic at San Gerardo Hospital in Monza (Milan) and Coordinator of the Interstitial Lung Diseases working group at the Italian Society of Respiratory Medicine, said, "IPF is a devastating disease with a mortality rate similar to many cancers and until now, no treatment options were available. This represents a clear step forward in the management of IPF and I wish to express, on behalf of all patients and the Italian scientific community, my sincere appreciation for the upcoming availability of Esbriet in our country."

Giacomo Di Nepi, Executive Vice President and Managing Director, Europe for InterMune, said, "We are very pleased to see the publication of our pricing and reimbursement agreement, which allows us to make Esbriet available very soon to Italian patients with mild to moderate IPF. Our entire organization is prepared to launch Esbriet in Italy and our Italian team is excited and fully committed to making Esbriet available to all appropriate IPF patients as rapidly as possible."

Publication in the Official Gazette means that Esbriet will be nationally reimbursed beginning 15 days from the publication date on the Italian Official Gazette, or June 29.  This will provide access to a number of patients in Italy; however, full access to patients will require up to three quarters, the time that is currently needed after launch in Italy to address all regional reimbursement procedures.

InterMune currently has an organization in Italy of 31 people, including 19 field-based personnel and 12 office-based personnel in the areas of management, medical, regulatory, finance, commercial and administration.  

The agreement with AIFA specifies that Esbriet may be prescribed by pulmonologists.  Esbriet will be reimbursed as a Hospital Product, Class H, and will be distributed, similarly to other specialty products, by the pharmacies of the hospitals designated by the Regions and Autonomous Provinces. Patients treated with Esbriet therapy will be recorded in a registry designed and maintained by AIFA to collect patient data and to ensure appropriate patient selection to fit the approved label.  Most medicines marketed to specialists in Italy are monitored via a similar registry.

As previously announced, reimbursement for Esbriet will be provided under a risk-sharing arrangement.  Patients' forced vital capacity (FVC) will be measured at six months post initiation of Esbriet therapy. Patients whose FVC declines, in absolute terms, by 10 percent or more during the first six-month treatment period will not be eligible for reimbursement and their cost of therapy during their treatment period will be credited to the National Health Care System. InterMune estimates that approximately 15 percent of patients that initiate therapy will have such an FVC decline.