HSE statement on negotiations with Vertex re Orkambi, Kalydeco and other treatments for Irish Cystic Fibrosis Patients

The most recent round of negotiations between the HSE and Vertex involving the commercial terms for the supply to Irish patients with Cystic Fibrosis of Vertex medicines has now concluded. The negotiations provided a positive outcome in relation to commercial terms, which now allows the means for a final process of approval to take place.
 
The following medicines are expected to be available and reimbursed subject to the conclusion of contract negotiations, the finalisation of logistical arrangements, and the completion of approval processes:
 
  • Orkambi for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene
  • Kalydeco film-coated tablets for the treatment of patients with cystic fibrosis (CF) aged 18 years and older who have an R117H mutation in the CFTR gene
  • Kalydeco granules for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene:G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R
 
Subject to approval, the agreement will, over time, also include certain other specified treatments and extension to other age cohorts of the population described above subject to market authorisation in Europe.
 
Last updated on: 12 / 04 / 2017