Vertex has welcomed the expanded reimbursement of KALYDECO (ivacaftor) to include the treatment of more children with cystic fibrosis.
KALYDECO was first listed on the PBS in 2014 for the treatment of CF in people aged 6 or older with a gating mutation.
The new listing for children aged 4 to 12 months with a gating mutation in the DF transmembrane conductance regulator (CFTR) gene and those aged 4 months or older who have at least one mutation in the CFTR gene that is responsive to ivacaftor.
Vertex said the new listing includes 83 additional mutations.
CF is a rare, life-shortening genetic disease that affects approximately 3,700 people in Australia. It is generally diagnosed at birth and leads to cumulative health decline over time.
“We are delighted that the Australian Government has expanded the reimbursement of KALYDECO. It marks further progress towards our mission of providing treatment for all people living with CF regardless of age or genotype. We acknowledge the ongoing work of the CF community in reaching this milestone and the recognition of the value that our innovative medicines bring to people living with CF,” said Sabrina Barbic, the senior country manager for Vertex in Australia and New Zealand.