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InterMune Reports First Quarter 2013 Financial Results and Business Highlights
Date:4/24/2013

mid-June 2013.  The price of Esbriet in Italy will be announced at the time of the publication.  In Italy, up to nine months are needed after a new product is launched to address the various regional access procedures before patient access to the product is achieved in every region.  
  • On March 20, 2013, the health technology appraisal body in England and Wales, NICE, recommended Esbriet® (pirfenidone) for treating IPF patients whose predicted forced vital capacity (FVC) is between 50 percent and 80 percent at the initiation of therapy.  The Final Appraisal Determination (FAD) recommends the prescription of Esbriet as long as InterMune makes the Patient Access Scheme (PAS) available.  The PAS is a confidential pricing and access agreement with the UK's Department of Health.  The NHS list price for Esbriet is £26,100 per full year of treatment.  At current rates of exchange this is equivalent to roughly $39,770 per patient per year.  According to the regulations in England, up to 90 days from the publication of the final guidance are required before a new product may be reimbursed in England.  Since the official publication of the final NICE guidance occurred today, the company currently plans to launch Esbriet by or before the middle of August.
  • Update on Other EU Countries -- InterMune currently expects to conclude pricing and reimbursement discussions in Ireland in June and if acceptable terms are agreed, to launch Esbriet in the third quarter.  Regarding the remaining two of the company's 15 top-priority European countries, Spain and the Netherlands, economic conditions in Spain and healthcare system changes in the Netherlands make it challenging to predict the date by which a company can expect to conclude pricing and reimbursement for a new product.  The company currently expects to provide an update on the pricing and reimbursement discussions on E
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