17 February 2014 - Kalydeco (ivacaftor) was registered on the Australian Register of Therapeutic Goods on 9 July 2013 for the treatment of cystic fibrosis (CF) in patients aged six years and older who have a G551D mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene.

The Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body, makes recommendations to the Australian Government about Pharmaceutical Benefits Scheme (PBS) listings. The PBAC considers each PBS listing submission having regard to the safety, clinical effectiveness and cost-effectiveness (value-for-money) of the medicine for the intended use, in comparison with other available treatments.

At its July 2013 meeting, the PBAC considered Kalydeco for PBS listing either as a Highly Specialised Drug or for inclusion on the Life Saving Drugs Program for the treatment of cystic fibrosis in patients aged six years and older who have a G551D mutation in the CFTR gene.

For more details, go to: http://www.health.gov.au/internet/main/publishing.nsf/Content/MC14-000305-pharmaceutical-benefits-sc...