Australia delays Kalydeco reimbursement decision

Australia's Pharmaceutical Benefits Advisory Committee (PBAC) deferred a reimbursement decision on Kalydeco ivacaftor to allow Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) time to submit a new price proposal for the cystic fibrosis (CF) drug. PBAC said at Vertex's current proposed price, Kalydeco's cost per quality-adjusted life year (QALY) gained is "too high and too uncertain" to list the CF drug on the Australian Pharmaceutical Benefits Scheme (PBS). Vertex could not be reached for comment on a potential revision to Kalydeco's pricing or on a timeframe for resubmission of a price proposal.

Australia's Therapeutic Goods Administration ( TGA) approved Kalydeco in July to treat CF in patients six years and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator ( CFTR) gene. The small molecule potentiator of CFTR is also approved in the U.S. and EU for the indication. ...