Vertex Pharmaceuticals Incorporated has reached a pricing and reimbursement agreement for Orkambi (lumacaftor/ivacaftor) with the German Federal Association of the Statutory Health Insurances (GKV-SV).
Orkambi is 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 CF transmembrane conductance regulator (CFTR) gene. Cystic fibrosis is a rare and life-shortening genetic disease caused by a defective or missing CFTR protein resulting from a mutation in the CFTR gene. The disease is present from birth and causes chronic lung infections and progressive damage to a number of organs throughout the body.
Vertex said that today’s announcement follows a comprehensive benefit assessment of the medicine by the German Federal Joint Committee (G-BA), which recognized the “considerable additional benefit” of Orkambi for people with cystic fibrosis who have two copies of the F508del mutation. Orkambi has been available to eligible patients in Germany since it was granted marketing authorization from the European Commission in November 2015, and the reimbursement agreement announced today took effect on December 16, 2016.
“Cystic fibrosis is a progressive disease, meaning that with each passing day, lung function can deteriorate and patients get sicker,” said David Gillen, M.D., Vice President of International Medical Affairs at Vertex. “We are pleased the German authorities approved Orkambi reimbursement for all eligible patients. The reimbursed price recognizes the clinical value of Orkambi and the need for Vertex’s continued investment in the research and development of new medicines for the two out of three people with CF still waiting for a treatment for the underlying cause of their form of the disease.”