Vertex finalizes Orkambi deal with Australia

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said it reached an agreement Sept. 3 with the Australian government for the reimbursement of cystic fibrosis drug Orkambi lumacaftor/ivacaftor. The country will list the drug on its Pharmaceutical Benefits Scheme (PBS), starting Oct. 1. Orkambi is approved to treat CF in patients ages six and older who have two copies of the F508del mutation.

Vertex spokesperson Heather Nichols told BioCentury Orkambi will be listed in Australia under a Managed Access Program (MAP), but declined to provide details. In July, the country's Pharmaceutical Benefits Advisory Committee (PBAC) recommended listing Orkambi under a MAP that would require Vertex to provide long-term data showing the drug's benefits are sustained for at least four years, or else the government's subsidy "would reduce to a level consistent with the evidence provided to the PBAC," according to the committee (see "Vertex Nears Orkambi Reimbursement Agreement with Australia"). ...