Benzinga | Jun 28, 2021 09:36AM EDT

Vertex Announces National Reimbursement Agreement In France For KAFTRIO And SYMKEVI For Eligible Cystic Fibrosis Patients

Vertex Pharmaceuticals Incorporated(NASDAQ:VRTX) today announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis (CF) medicines KAFTRIO(r) (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor and SYMKEVI(r) (tezacaftor/ivacaftor) in combination with ivacaftor. Both medicines will be available for all eligible patients once the agreement has been published in the French Official Journal.

"Today's announcement represents a major milestone for CF patients in France. Through this national reimbursement agreement, eligible patients 12 years and older now have access to KAFTRIO and SYMKEVI. For those living with CF, we are delighted to have reached this agreement so quickly and that the French Health Authorities have recognized the value of both medicines," said Ludovic Fenaux, Senior Vice President, Vertex International.

The reimbursement agreement enables broad access to KAFTRIO(r) for people with CF ages 12 years and older with one F508del mutation and one minimal function mutation. The triple combination therapy will also be reimbursed for patients who are homozygous for the F508del mutation in the CFTR gene, representing a new therapeutic option for treating physicians.In November 2020, the Transparency Commission (TC) of the French National Authority for Health (HAS) granted KAFTRIO(r) an ASMR 2 rating, which indicates "a significant improvement in medical service rendered." Of the 250 first-time listing medicines issued in 2019 by the TC, only two received such a rating.

Under the terms of the new reimbursement agreement, SYMKEVI(r) will be reimbursed for people with CF ages 12 years and older with one F508del mutation and one of the mutations resulting in residual activity (F/RF) of the CFTR protein as listed in the Summary of Product Characteristics (SmPC). It will also be funded for patients who are homozygous for the F508del mutation in the CFTR gene.