Vertex Pharmaceuticals announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA) has agreed to reimburse Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The agreement is published online in the Italian Official Gazette.
Regional authorities will now begin implementation to provide the hundreds of eligible patients in Italy access to this important medicine. Recent European pricing and reimbursement agreements have enabled broad access to Orkambi for thousands of eligible patients in Austria, Denmark, Germany, Ireland, Italy and Luxembourg. Negotiations continue in a number of other countries where CF is prevalent, including France and the United Kingdom.
“We are pleased to have reached this agreement on behalf of CF patients in Italy who have been waiting for this important medicine,” said Simon Bedson, senior vice president and international general manager at Vertex. “We continue negotiations with other countries including France and the United Kingdom, and we encourage these national health authorities and governments to work quickly with us to achieve reimbursement for all patients who may benefit.”