HEALTH minister Greg Hunt has confirmed the approval of a recommendation from the Pharmaceutical Benefits Advisory Committee for the PBS listing of Kalydeco (ivacaftor) from 01 May.
The Section 100 listing includes an extension to the current approval for patients aged six and above to also include patients aged 2-5 years, with the drug to be available to patients who have a GS51D or other gating (class III) mutation in the cystic fibrosis transmembrane regulator (CFTR) gene.
The approval follows an agreement with the medication's sponsor, Vertex Australia, which will also now supply the drug at no charge to 2-5 year olds prior to its PBS listing in three months.
A long term safety study for Kalydeco showed an improvement in the relative risk of hospitalisation in patients aged under six years.
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