Vertex Pharmaceuticals Incorporated has reached an agreement with the Health Service Executive (HSE) in the Republic of Ireland to fund Orkambi (lumacaftor/ivacaftor).
Orkambi is appropriate for all of the approximately 500 people in Ireland with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation.
The agreement also expands access to Kalydeco (ivacaftor) for children ages 2 to 5 with any approved gating mutation (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D) and to people ages 18 and older who have an R117H mutation. The company said that these reimbursements are effective immediately.
Furthermore, this innovative long-term agreement also enables rapid access for people with these mutations if the labels of the existing medicines are expanded to cover additional age groups and if new Vertex medicines are approved for these populations.
“We are pleased that these additional Irish CF patients will finally join the thousands of others around the world who are already benefitting from ORKAMBI and KALYDECO,” said Simon Bedson, Senior Vice President and International General Manager at Vertex.
“We thank the leaders in Ireland for working with us toward an innovative reimbursement agreement that provides access to these important medicines and also recognizes the need for Vertex’s continued investment in the research and development of new medicines for those people with CF, many of whom are still waiting for a treatment for the underlying cause of the disease.”