Vertex provides Kalydeco reimbursement update

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said in its 2Q14 financial results that cystic fibrosis patients in Australia still can't access Kalydeco ivacaftor through public reimbursement. Kalydeco was approved in Australia last July; however, the company said Kalydeco is not yet listed on the Australian Pharmaceutical Benefits Scheme (PBS). In March, the Pharmaceutical Benefits Advisory Committee (PBAC) reiterated a recommendation that at Vertex's proposed price, Kalydeco is only cost-effective in patients who respond to the same extent and duration as shown in clinical trials. PBAC recommended listing Kalydeco on the PBS for reimbursement on a "pay for performance" scheme.

On a conference call to discuss its 2Q14 results, Vertex said it submitted a proposal in response to the PBAC recommendation to the Australian Department of Health in May, but declined to disclose details. Vertex expects a decision this half, and said its 2014 revenue guidance is in part contingent on securing reimbursement of Kalydeco in Australia. Vertex reiterated full-year revenue guidance of $520-$550 million, including Kalydeco revenues of $470-$500 million. Kalydeco is reimbursed in 18 countries. ...