Benzinga | Jun 25, 2021 01:45PM EDT

Vertex Announces New Portfolio Reimbursement Agreement in Italy Including KAFTRIO, SYMKEVI and Additional Indications of ORKAMBI and KALYDECO for Eligible Patients With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced it has reached a new portfolio agreement with the Italian Medicines Agency, AIFA, for the reimbursement of all of Vertex's approved medicines for the treatment of cystic fibrosis (CF), including KAFTRIO(r) (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor.

Italian patients ages 12 years and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene will now have access to KAFTRIO(r) (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor. Additionally, under the terms of the agreement, eligible patients ages two years and older with CF who have two copies of the F508del mutation in the CFTR gene (F/F) will now have access to ORKAMBI(r) (lumacaftor/ivacaftor). Eligible patients ages 12 years and older who either have two copies of the F508del mutation (F/F), or one copy of the F508del mutation and another responsive residual function mutation in the CFTR gene (F/RF), will have broad access to SYMKEVI(r) (tezacaftor/ivacaftor) in combination with ivacaftor. The agreement also expands access to KALYDECO(r) (ivacaftor) for eligible patients ages one year and older. In addition, the agreement covers any new approved indication extensions for Vertex's CF medicines submitted and approved for reimbursement during the term of the contract.

Ludovic Fenaux, Senior Vice President, Vertex International, commented, "This agreement is an important milestone for cystic fibrosis patients in Italy. Our medicines have fundamentally changed the way CF is treated, and we are delighted with this broad portfolio agreement which includes access for younger patients to ORKAMBI and KALYDECO and access to SYMKEVI and KAFTRIO for patients 12 years and older. I would like to thank AIFA and all parties involved for their collaboration, commitment and engagement in quickly reaching this agreement."

KALYDECO(r) was first reimbursed in Italy in 2015, followed by ORKAMBI(r) in 2017 for patients 12 years and older. Vertex's CF medicines are reimbursed in over 25 countries around the world including Australia, France, Germany, the Republic of Ireland, the Netherlands, Spain, Sweden, the U.K. and the U.S.